This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Pregabalin for Abdominal Pain From Adhesions (NCT00310765), a randomized phase 4 study. The primary outcome is Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00310765 |
| Phase | Phase 4 |
| Condition | Abdominal Pain, Surgical Adhesions |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Quadruple |
| Enrollment | 18 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Henry Ford Health System |
| Results posted | Yes |
2. Clinical Question
Population
Patients with severe abdominal pain attributed to surgical adhesions were the intended population. The registry describes daily pain and sleep-score reporting, and lists an enrollment of 18. The detailed characteristics of enrolled patients are not reported in the registry record.
Intervention
The active treatment was pregabalin, with a blinded phase of 75 mg or 150 mg twice daily for 7 weeks. The record describes dose doubling on day 3 if adequate pain relief was not obtained. After a 1 week washout, the record describes open-label pregabalin 150 mg twice daily for 4 weeks.
Comparator
The comparator was look-alike placebo during the blinded phase. The placebo arm description gives 75 mg or 150 mg twice daily, followed by a 1 week washout and open-label pregabalin 150 mg twice daily for 4 weeks. The exact sequence and analysis of each participant's treatment periods are not reported in the registry record.
Primary question
The trial sought to evaluate whether pregabalin reduced abdominal pain attributed to adhesions. Pain was recorded on a Likert 11-point numeric scale, from no pain at level 0 to severe pain at level 10. The registry describes a positive change of 2 points from each patient's baseline as the primary endpoint, with assessments described at week 8 and week 12.
The randomized, crossover design means the comparison was not simply a parallel assignment maintained throughout. The registry identifies a blinded pregabalin-versus-placebo phase and subsequent open-label pregabalin, with a washout between phases. However, it does not report enough detail to establish precisely how all treatment sequences were assigned, how the crossover comparison was constructed, or which observations contributed to the primary analysis.
The scientific question is clinically focused, but the registry does not report the primary outcome values or a treatment-effect estimate. It therefore does not establish from the posted results how pain scores differed between pregabalin and placebo. The record lists improved sleep scores as a secondary outcome, but does not report a numerical result for that outcome either. Interpretation must distinguish the study's stated question from evidence about the answer: the design describes what was intended to be compared, while the posted registry record does not provide the comparison needed to estimate the effect.
3. Trial Design
The registry describes a Phase 4 randomized, quadruple-masked crossover trial sponsored by Henry Ford Health System. The study began in 2006-03, had a primary completion date of 2008-08, and is listed as terminated. The reported enrollment is 18. The registry says the study was terminated early due to low enrollment; it does not report a more detailed account of the termination or whether every planned assessment was completed.
During the blinded phase, patients were randomly assigned to pregabalin or look-alike placebo. The active-treatment description gives pregabalin 75-150 mg twice daily for 7 weeks; the placebo description gives placebo 75 mg or 150 mg twice daily for the same period. A 1 week washout is described before open-label pregabalin 150 mg twice daily for 4 weeks. The record also says patients could double the dose on day 3 if adequate pain relief was not obtained. It does not give the number of participants assigned to each sequence or explain how dose changes were incorporated into analysis.
A crossover design can compare treatment periods within participants, which can account for stable differences between people when the analysis is constructed appropriately. It also makes period, sequence, and carryover effects relevant considerations. These are general features of crossover studies, not claims about what happened in this trial. The registry does not report the statistical handling of these issues. Although it identifies the model as crossover, the detailed assignment sequence and analysis population are not described.
The primary outcome is a continuous pain score collected through daily diaries. Sleep scores were listed as a secondary outcome. The registry refers to baseline and week 2 through week 12 in the timeframe, while the endpoint description also identifies the stated 2-point change at week 8 and week 12. It does not explain how daily diary observations were condensed or compared for the primary analysis. The record's description of the endpoint timing is therefore not sufficiently detailed to reconstruct an analysis.
The registry's population description says the number of patients required per treatment group was based on rates from published articles, but gives no target enrollment or detailed justification. The record attributes early termination to low enrollment. It does not report whether any interim analyses were conducted, whether the original target was revised, or how the termination affected the planned analysis.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: After signing consent patients completed a one week baseline pain and sleep evaluation. Patients completed a Short-Form McGill Pain Questionaire during screening and at randomization. Patients had an average daily diary score of at least 4 on the the Likert scale during the baseline week and 5 diary recordings with stable pain medication doses.
Placebo Controlled Double Blind
| Stage | Active Drug | Placebo |
|---|---|---|
| STARTED | 11 | 7 |
| COMPLETED | 8 | 5 |
| NOT COMPLETED | 3 | 2 |
Open Label
| Stage | Active Drug | Placebo |
|---|---|---|
| STARTED | 8 | 5 |
| COMPLETED | 7 | 3 |
| NOT COMPLETED | 1 | 2 |
Analysis population for the primary outcome, as defined in the registry: The number of patients required per treatment group to achieve greater tha 80% power with alpha=0.05 were based on rates from published articles. The study was terminated early due to low enrollment.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Active Drug | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 11 | 7 | 18 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 11 | 5 | 16 |
| Age, Categorical: >=65 years | Participants | 0 | 2 | 2 |
| Age, Continuous | years | 44.27 (SD 11.73) | 48.85 (SD 16.94) | 46.05 (SD 13.69) |
| Sex: Female, Male: Female | Participants | 11 | 7 | 18 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 11 | 7 | 18 |
6. Primary Endpoint
The registry lists the primary outcome as Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo, measured over Baseline and week 2 through week 12.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint concerns abdominal pain assessed with a daily patient diary. The registry describes a Likert 11-point numeric scale, with level 0 representing no pain and level 10 representing severe pain. It states that the scale assumes pain intensity changes linearly along that continuum. The outcome is described as a mean, with standard deviation as the dispersion measure, and the unit is listed as units on a scale.
The registry describes the primary endpoint as a positive change of 2 points from each patient's baseline, assessed at week 8 after the blinded study and at week 12 during the open-label portion. It also gives the timeframe as baseline and week 2 through week 12. Those descriptions do not fully explain whether the intended primary comparison used a particular daily score, an average across days, or a change calculated over a specified interval. The exact operational definition and analysis are not reported in the registry record.
Patient-reported pain scores are used because pain is an experience that cannot be measured directly by an external instrument in the same way as a laboratory value. A repeated diary can capture variation during treatment rather than relying only on recall at a later visit. These are general reasons for using such measures; they do not show that the diary was complete or that the measure was analyzed as planned in this trial.
No primary-outcome means, standard deviations, changes from baseline, between-treatment estimate, or uncertainty interval are reported in the registry record. Consequently, the endpoint description defines the intended measurement but does not provide a numerical result about the treatment comparison.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry establishes that this study asked a randomized treatment question, but it does not provide the efficacy results needed to answer it. No primary-outcome comparison is reported: there are no treatment-specific pain means or changes, no estimated contrast, no confidence interval, and no p-value in the record. The stated endpoint and the fact that enrollment was 18 do not substitute for those results. It is therefore not possible to describe the magnitude or precision of a pregabalin-versus-placebo difference from this record.
The study is listed as terminated, with low enrollment given as the reason. Early termination can leave fewer observations than planned, but the registry does not report the planned enrollment target, the number assessed at each time point, or how many participants contributed to the primary analysis. The extent to which termination affected the information available cannot be quantified from the record. In particular, enrollment alone does not show how much outcome information was collected or whether the crossover periods were completed.
The endpoint description includes a 2-point change criterion, but that criterion is not a reported treatment effect. It describes a threshold in the stated endpoint definition, not a result showing that either treatment group reached it or that the treatments differed by that amount. The record also refers to measurements at week 8 and week 12, including an open-label period. Without the outcome values and a clear comparison definition, it is not possible to interpret those time points as evidence for a blinded treatment contrast.
The registry identifies the study as randomized and quadruple-masked, features intended to limit bias in assignment and assessment. Those design labels do not establish that bias was absent, and the registry does not describe the masking roles or report an assessment of masking. Further, the crossover model makes treatment sequence, period, and possible carryover relevant to analysis in general. The registry does not state how these were addressed, so the validity of a crossover estimate cannot be evaluated from the posted information.
The safety entries report serious adverse events and other adverse events by group, but those figures should not be taken as a complete comparative safety analysis. The registry does not report exposure-adjusted rates, statistical comparisons, or enough information to determine whether adverse-event categories overlap. The listed serious-event term is also not a treatment-effect estimate. The safety entries can be described as recorded counts, but they do not resolve the primary pain question.
Overall, the record supports a description of the planned randomized crossover study and its reported termination, not a conclusion about the efficacy of pregabalin for this indication. The absence of a posted primary comparison means that neither the direction nor the size nor the precision of a treatment difference can be assessed. This is absence of a reported estimate in the registry record, not evidence that the treatments were equivalent or that there was no effect.
9. Statistical Methods Explained
The registry identifies the primary measure as the mean of a continuous outcome, with standard deviation as its dispersion measure. That classification indicates how the endpoint was intended to be summarized, but it does not reveal the treatment effect. A mean describes the central value of observed scores, while a standard deviation describes variability among the values. Neither summary alone establishes whether two treatment conditions differ, and the registry does not report either summary for the pain outcome.
What does a confidence interval communicate?
In general, a confidence interval expresses the statistical uncertainty around an estimated effect under the assumptions of the analysis. Its width reflects how precisely the effect has been estimated: a wider interval indicates less precision, while a narrower interval indicates greater precision. An interval can also show which effect sizes remain compatible with the data and model. No confidence interval for the primary outcome is reported in the registry record, so the precision of any treatment comparison cannot be judged.
A p-value, when reported, describes how compatible the observed data are with a specified null model, given the analysis assumptions. It does not measure the probability that a treatment works, nor does a value by itself describe the size or clinical importance of an effect. The record does not report a p-value for the primary comparison. The endpoint's stated 2-point change threshold should not be confused with a significance test: a change criterion and a test of a treatment contrast answer different statistical questions.
Why does the crossover structure matter?
In general, a crossover design assigns participants to treatment sequences so that treatment conditions can be compared across periods. When suitable data and analysis are available, comparisons within the same participant can reduce the influence of stable differences between participants. The design also creates potential concerns: scores may change over time, treatment effects can differ by period, and an earlier treatment could affect a later period. These are general considerations, not findings about this trial.
This record describes a 1 week washout between the blinded treatment phase and open-label pregabalin. A washout is intended in general to separate treatment periods, but its presence alone does not establish that carryover was absent. The registry does not report an analysis of sequence, period, or carryover, and it does not specify how the within-participant structure was reflected in the model. Without those details, an outside reader cannot reconstruct the intended crossover analysis or determine whether a simple parallel-group interpretation would be appropriate.
How should the pain scale be understood?
The registry describes a Likert 11-point numeric scale, bounded by 0 for no pain and 10 for severe pain. It states that the scale assumes a linear continuum of pain intensity. This assumption treats the numeric spacing as meaningful for summarizing changes. In general, a numerical rating scale is often analyzed as a continuous measure, but the appropriateness of that approach depends on the measure and analysis plan. The record does not state what model or test was used, whether the scale distribution was assessed, or how daily observations were summarized.
Daily recording can provide repeated observations and make within-person patterns visible. Repeated measures are correlated: an individual's score on one day is generally related to their scores on other days. General statistical methods account for this dependence rather than treating every diary entry as an independent observation. The registry does not report how diary entries were handled, what constituted a valid diary, how missing daily entries were treated, or whether the endpoint was calculated as a single-day score or an average. Those omissions prevent a full assessment of the uncertainty calculation.
What do the planning assumptions mean?
The registry includes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It describes the target effect as a stated fraction of the observed effect. Such calculations are planning illustrations, not observed power and not evidence about the result of this trial. The primary outcome has several categories or time points and was not reduced to one comparison for this calculation. No resulting participant-per-arm planning values are reported in the record.
The registry separately says that the number required per treatment group was based on rates from published articles. It does not give the actual planned number or a detailed sample-size justification. The general principle is that a planning calculation depends on assumptions about the treatment effect, outcome variability, significance level, allocation, and analysis. If those assumptions are uncertain, the planned enrollment may not yield the intended precision. In this record, the low-enrollment termination is reported, but the effect on statistical precision cannot be quantified without the missing analysis and outcome details.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists the primary pain outcome and improved sleep scores as a secondary outcome. It also describes pain assessment at baseline and week 2 through week 12, and refers to the stated primary change at week 8 and week 12. Considering multiple outcomes or time points raises a general multiplicity issue: repeated testing can increase the chance of finding an apparently notable result by chance if the analysis does not account for the number of comparisons. The registry record does not report a multiplicity adjustment, a hierarchy of tests, or which time point was intended to carry the primary inference.
The primary outcome has several categories or time points and was not reduced to one comparison in the planning illustration. This further limits interpretation of any derived planning figures; no such figures are reported. The record does not identify a prespecified single primary contrast that could be used to interpret the planned analysis unambiguously.
Daily pain and sleep scores were reported by patients throughout the study, according to the arm descriptions. The registry does not report the amount of missing diary data, the reasons for missingness, or the method used to handle missing observations. It also does not state whether analyses used all randomized participants, participants who completed treatment, or another analysis population. No imputation method, sensitivity analysis, or missing-data assumption is reported.
These omissions matter because missingness and analysis-population choices can affect both the estimated effect and its uncertainty, particularly when repeated observations and treatment periods are involved. The registry does not provide enough information to determine how these issues were handled. This is not evidence that a specific method was or was not used outside the posted record; it means the method is not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Active Drug 150 mg Double-blind and 300 mg Open-label | 0 | 5 | 0.0% |
| Active Drug 300mg Double-blind and 300mg Open-label | 1 | 6 | 16.7% |
| Placebo (150 mg or 300mg): Double-Blind | 0 | 7 | 0.0% |
| Placebo (300 mg Active Drug): Open-label Only | 0 | 5 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Active Drug 150 mg Double-blind and 300 mg Open-label | 0 of 5 |
| Active Drug 300mg Double-blind and 300mg Open-label | 0 of 6 |
| Placebo (150 mg or 300mg): Double-Blind | 0 of 7 |
| Placebo (300 mg Active Drug): Open-label Only | 0 of 5 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Active Drug 150 mg Double-blind and 300 mg Open-label | 3 of 5 |
| Active Drug 300mg Double-blind and 300mg Open-label | 3 of 6 |
| Placebo (150 mg or 300mg): Double-Blind | 2 of 7 |
| Placebo (300 mg Active Drug): Open-label Only | 1 of 5 |
Most frequent serious adverse event terms
| Event term | Organ system | Active Drug 150 mg Double-blind and 300 mg Open-label | Active Drug 300mg Double-blind and 300mg Open-label | Placebo (150 mg or 300mg): Double-Blind | Placebo (300 mg Active Drug): Open-label Only |
|---|---|---|---|---|---|
| Suicide attempt | Psychiatric disorders | 0 of 5 | 1 of 6 | 0 of 7 | 0 of 5 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Active Drug 150 mg Double-blind and 300 mg Open-label | Active Drug 300mg Double-blind and 300mg Open-label | Placebo (150 mg or 300mg): Double-Blind | Placebo (300 mg Active Drug): Open-label Only |
|---|---|---|---|---|---|
| dizziness | Ear and labyrinth disorders | 1 of 5 | 0 of 6 | 0 of 7 | 1 of 5 |
| headache and hyperactivity | Nervous system disorders | 1 of 5 | 0 of 6 | 0 of 7 | 0 of 5 |
| night sweats | Blood and lymphatic system disorders | 0 of 5 | 1 of 6 | 0 of 7 | 0 of 5 |
| drowsiness | General disorders | 0 of 5 | 1 of 6 | 0 of 7 | 0 of 5 |
| dizziness and blurred vision | Nervous system disorders | 1 of 5 | 0 of 6 | 0 of 7 | 0 of 5 |
| hand numbness | Nervous system disorders | 0 of 5 | 1 of 6 | 0 of 7 | 0 of 5 |
| gastroenteritis and dizziness | Metabolism and nutrition disorders | 0 of 5 | 0 of 6 | 1 of 7 | 0 of 5 |
| pedal edema | Blood and lymphatic system disorders | 0 of 5 | 0 of 6 | 1 of 7 | 0 of 5 |
Serious events with the highest arm-level rate: suicide attempt (16.7%).
The registry reports serious adverse events, other adverse events, and deaths separately for four group entries. For the entries titled Active Drug 150 mg Double-blind and 300 mg Open-label, Active Drug 300mg Double-blind and 300mg Open-label, Placebo (150 mg or 300mg): Double-Blind, and Placebo (300 mg Active Drug): Open-label Only, the serious-event counts are respectively 0 of 5, 1 of 6, 0 of 7, and 0 of 5. The other-adverse-event counts are respectively 3 of 5, 3 of 6, 2 of 7, and 1 of 5. Deaths are listed as 0 in each entry.
The registry also lists Suicide attempt at 16.7% among the top serious adverse-event terms. It does not give the count or denominator associated with that term in the record, so the percentage should not be translated into a count or attributed to a particular group without additional information. The group descriptions include blinded and open-label periods, and the registry does not explain whether participants can appear in more than one entry. The counts should therefore not be added or treated as independent group totals.
These are descriptive registry entries, not adjusted comparisons of safety risk. The record does not report exposure-adjusted rates, event timing, attribution to study treatment, or statistical uncertainty. Small event counts can be especially imprecise, and absence of a reported event in an entry does not establish absence of risk.
12. What the Result Does, and Does Not, Mean
The record is useful for understanding the study question and design: pregabalin was compared with look-alike placebo in a randomized, quadruple-masked crossover trial of abdominal pain attributed to adhesions, followed by open-label pregabalin. It also documents the intended patient-reported pain measure and the fact that the study was terminated early because of low enrollment. These details explain what the study set out to investigate.
The record does not report the primary pain results. Without group-specific outcome summaries or a treatment contrast, it is not possible to say whether pain scores were higher or lower under either blinded condition, how large any difference was, or how precisely it was estimated. No reported estimate also means there is no basis in this record for deciding whether a result met the stated change criterion. The endpoint definition is not itself a finding.
Likewise, the record does not establish that pregabalin and placebo had equivalent effects. Equivalence requires an appropriately designed comparison and a sufficiently precise estimate relative to a stated margin; the registry does not report such a margin or comparison. Nor does the absence of a posted result show that the treatments had no effect. It reflects the information available in the registry record, which lacks the primary-outcome analysis.
The safety figures provide counts for listed group entries, but do not amount to a complete comparative safety evaluation. They do not provide exposure-adjusted analyses, uncertainty intervals, or full event-level descriptions. The suicide-attempt term is reported as a percentage without a corresponding denominator in the registry record. These data should be read as limited descriptive information rather than a definitive comparison.
In short, the trial's registry record establishes the intended question and reports early termination, but it does not provide the numerical evidence necessary to answer the efficacy question. Any conclusion about treatment effect, precision, or comparative safety would require results and analysis details that are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial illustrates why a design description and an outcome estimate are different kinds of evidence. Randomization, masking, and crossover structure describe how a comparison was intended to be organized. They do not reveal the observed pain scores or the magnitude of a treatment contrast. When the primary result is absent, the central statistical question—how much the outcome differed and with what precision—remains unanswered in the registry record.
Early termination for low enrollment is also important context. A smaller-than-planned study can provide limited information, but the record does not give the planned target or the number contributing to each outcome analysis. It is therefore not possible to quantify the effect of termination on precision or to infer that a non-significant result occurred. No primary comparison is reported at all.
The crossover structure highlights the importance of reporting how treatment sequences and periods were analyzed. Within-participant comparisons can be informative in general, yet interpretation depends on the handling of period effects, sequence, carryover, and incomplete observations. The registry identifies the study as crossover and describes a washout, but does not report the analysis needed to assess these features.
The endpoint description also shows why operational clarity matters. A daily pain scale, a stated change threshold, and assessments at multiple time points need a clear analysis definition so readers can understand what was compared. The record does not resolve how diary observations were combined or how the week 8 and week 12 descriptions relate to the primary contrast. Without such detail and a reported estimate, readers cannot assess either statistical or clinical importance.
For biostatisticians and clinical researchers, this record is a reminder that registration details can describe intent while leaving the evidence for the primary question unavailable. Transparent outcome reporting, analysis methods, uncertainty estimates, and handling of missing data are needed to interpret a trial's results responsibly.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpretation is that the registry record does not report the primary pain outcome results. It gives no treatment-specific means or standard deviations, effect estimate, confidence interval, or p-value. Consequently, the size, direction, and precision of the primary comparison cannot be evaluated.
The trial was terminated early because of low enrollment, and enrollment is listed as 18. The planned enrollment target and numbers contributing to each outcome are not reported. The record therefore does not permit an assessment of how much information was lost, whether follow-up was complete, or how termination affected the planned comparison.
The endpoint description gives a pain-scale range and a 2-point change criterion, but does not clearly specify the precise summary of daily diary values used for analysis. It refers to baseline and week 2 through week 12, and separately describes the primary endpoint at week 8 and week 12. The relationship between these timings is not explained. The statistical model and treatment contrast are also not reported.
The record identifies a crossover model and describes a washout, but does not report treatment sequence details or how period, sequence, or possible carryover effects were considered. Missing-data methods and analysis populations are not reported. Multiplicity handling for the pain time points and the secondary sleep outcome is also not reported.
Finally, the safety entries are descriptive and do not include exposure-adjusted comparisons or uncertainty estimates. Because group descriptions span blinded and open-label treatment and the registry does not explain participant overlap between entries, the counts should not be pooled. These limitations are specific to the information available in the registry record and do not establish what may have been analyzed or reported elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pregabalin for Abdominal Pain From Adhesions — NCT00310765.
- Registry record last updated 2023-10-23; status last verified 2023-09.
- Results first posted 2023-10-23.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT00310765 is a Phase 4 randomized, quadruple-masked crossover trial sponsored by Henry Ford Health System. It studied pregabalin for abdominal pain attributed to adhesions, comparing active treatment with look-alike placebo during a blinded phase and describing open-label pregabalin after a washout. The reported enrollment is 18. The study began in 2006-03, reached primary completion in 2008-08, and is listed as terminated because of low enrollment.
The primary endpoint was patient-reported abdominal pain on a Likert 11-point numeric scale, described through daily diaries and a stated 2-point change from baseline at specified follow-up times. Improved sleep scores were listed as a secondary outcome. The registry record does not report a primary treatment comparison, its precision, or the statistical analysis methods needed to reconstruct that comparison. Adverse-event counts are listed by group entry, but do not provide an adjusted comparative safety analysis.