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 A Real-World Evidence Study to Evaluate the Effects of Voltaren Use on Mobility and Quality of Life in Participants With Knee Osteoarthritis Pain (NCT06379893), a na phase 4 study. The primary outcome is Change From Baseline in the Average Minutes of Moderate and Vigorous Physical Activity (MVPA) at Week 1.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06379893 |
| Phase | Phase 4 |
| Condition | Pain |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 196 |
| Arms in the primary outcome | n/a |
| Lead sponsor | HALEON |
| Results posted | Yes |
2. Clinical Question
Population
Participants with knee osteoarthritis pain. The study enrolled 196 participants; the primary endpoint analysis population is described as the modified Intent-To-Treat population, with eligibility criteria based on meeting inclusion and exclusion criteria, using study product at least once, and having at least one post-baseline quality-of-life questionnaire supporting a secondary endpoint assessment.
Intervention
Voltaren Gel, applied topically each day according to label and leaflet instructions for up to 21 days. Participants were also instructed to wear an Actigraph activity tracker on the wrist throughout the day for up to 21 days, following training and the applicable instructions.
Comparator
There was no control group or like-for-like comparison. The study used a single-group design, and all participants were analyzed as one group rather than comparing formulations or treatments.
Primary question
The primary endpoint asks how average minutes of moderate and vigorous physical activity changed from baseline to Week 1, as measured by the connected Actigraph tracker. A positive change was defined in the registry record as improvement. The numerical change, its uncertainty, and any statistical test result are not reported in the registry record.
The study also set out to examine mobility and quality-of-life measures. Listed secondary outcomes include daily step counts, sedentary and non-sedentary time, gait measures, morning mobility, and the WOMAC physical function score at Weeks 1, 2, and 3. The brief summary also names sleep, mood, and engagement in daily activities as quality-of-life interests, but results for these measures are not reported in the registry record.
3. Trial Design
This was a prospective Phase 4 real-world evidence study with a single-group design. The registry record lists 196 participants enrolled and identifies Voltaren Gel as the intervention. Participants were to apply the gel topically each day according to label and leaflet instructions for up to 21 days. They were also instructed to wear an Actigraph wrist device throughout the day for up to 21 days. The study was completed; its start date was 2024-04-25 and its primary completion date was 2024-10-29.
Allocation is listed as not applicable, masking as none, and the model as single group. The registry record explicitly says the study was not intended to compare the effectiveness of three formulations: participants were analyzed as a single group. There was no randomized control group or other comparator, so changes over time cannot be separated from changes that might have occurred for other reasons. The design therefore describes within-group change, rather than a comparative treatment effect.
The primary endpoint was change from baseline in average minutes of moderate and vigorous physical activity at Week 1. The tracker measured activity, and the planned analysis used a mixed model with repeated measures. The baseline average was defined using non-missing days from Day -6 through Day 0. Other listed outcomes assess activity, mobility, gait, morning stiffness, and physical function at later time points. The registry record lists 18 outcome measures and 39 analyses, but detailed results for those outcomes are not reported in the registry record.
The record does not report a control condition, randomization procedure, or masking beyond listing masking as none. The specific clinical and operational details beyond those described in the record are not reported in the registry record. In particular, further information about participant characteristics, adherence, and how the study population represents routine users is not reported in the registry record. These omissions limit how fully the real-world setting and the reach of the findings can be assessed.
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: A total of 214 participants were screened during study of which 196 participants were enrolled and received Voltaren Gel. A total of 194 participants completed the study.
Overall Study
| Stage | Voltaren Gel |
|---|---|
| STARTED | 196 |
| COMPLETED | 194 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Voltaren Gel |
|---|---|
| Withdrawal by Subject | 1 |
| Sponsors' decision | 1 |
Analysis population for the primary outcome, as defined in the registry: mITT Population. This study was designed as a single-arm real-world evidence (RWE) study to evaluate the effectiveness of Voltaren gel. There was no intention to compare the effectiveness of the three formulations within the population; therefore, all participants were analyzed as a single group. The reported results apply to the entire study population ("all groups") because there were no separate Arms/Groups in the study design.
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.
Population: The enrolled population included all participants who met the inclusion/exclusion criteria as recorded on the 'Participant Eligibility: Inclusion/Exclusion Criteria' electronic case report form (eCRF) page.
| Characteristic | Unit | Voltaren Gel |
|---|---|---|
| Participants analysed | 196 | |
| Age, Continuous | years | 61.8 (SD 9.33) |
| Sex: Female, Male: Female | Participants | 118 |
| Sex: Female, Male: Male | Participants | 78 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 6 |
| Race (NIH/OMB): White | Participants | 188 |
| Race (NIH/OMB): More than one race | Participants | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race/Ethnicity, Customized: Hispanic or Latino | Participants | 19 |
| Race/Ethnicity, Customized: Not Hispanic or Latino | Participants | 20 |
| Race/Ethnicity, Customized: Missing | Participants | 157 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in the Average Minutes of Moderate and Vigorous Physical Activity (MVPA) at Week 1, measured over Baseline and Week 1.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | minutes |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the change from baseline in average minutes of moderate and vigorous physical activity at Week 1. Moderate and vigorous physical activity is abbreviated as MVPA in the registry record. A connected Actigraph activity tracker worn by participants measured activity. The endpoint is continuous: it records minutes, rather than classifying participants into categories. The registry record defines change by subtracting the baseline average from the Week 1 average, and says that a positive change indicates improvement.
Baseline average MVPA was defined as the sum of MVPA minutes over the baseline period divided by the duration of that period. The baseline period used the number of non-missing days between Day -6 and Day 0. The Week 1 comparison therefore evaluates change from an activity level measured over the baseline period to the Week 1 average. The registry record does not report the actual baseline or Week 1 averages, the estimated change, or uncertainty around that estimate.
Wearable measurement offers a way to quantify day-to-day physical activity without relying only on a participant’s recollection. This is a general measurement rationale, not evidence that the tracker captures every aspect of mobility or that the activity change reflects a particular cause. The endpoint was selected to address physical activity, one of the study’s stated interests alongside mobility and quality of life. Its clinical interpretation depends on the size and precision of the estimated change, which are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the primary endpoint and analysis method but does not report the numerical primary result. The estimated change in average MVPA minutes at Week 1, its standard deviation, any confidence interval, and any p-value are not reported in the registry record. As a result, the direction and magnitude of the observed primary change cannot be assessed from the posted information. The endpoint definition states that a positive change would indicate improvement, but that definition is not itself evidence of an observed positive change.
The study enrolled 196 participants and analyzed the primary endpoint in a modified Intent-To-Treat population. Those details describe the study population and analysis definition; they do not substitute for an outcome estimate. Without the number of participants contributing data at each time point, the estimate and its precision, readers cannot judge how complete the primary endpoint data were or how stable the result might be.
The single-group design is central to interpretation. Any reported change would represent change over time among participants using Voltaren Gel, not a contrast against a concurrent untreated or alternative-treatment group. Without a control comparison, changes cannot be confidently attributed to the gel rather than to other influences, including natural fluctuation, changes in activity, expectations, or other aspects of participants’ lives. These are general concerns for interpreting uncontrolled before-and-after data, not findings about what occurred in this study.
The primary endpoint was measured at Week 1, while the intervention and tracker use could continue for up to 21 days. The registry record also lists secondary outcomes across Weeks 1, 2, and 3, including steps, sedentary time, gait, morning mobility, and physical function. Numerical results for these outcomes are not reported in the registry record, so they cannot provide corroboration or context for the primary endpoint in this record.
The record lists a repeated-measures model, but does not give its estimated treatment-period changes, model uncertainty, or specific implementation details. A confidence interval, when reported, describes a range of values compatible with the data under the model and its assumptions; it helps readers assess precision. No such interval for the primary result is reported in the registry record. The statistical significance of the primary endpoint is also not reported in the registry record. Neither the design description nor the stated analysis method allows a conclusion about the endpoint’s result in the absence of the estimate.
Overall, the registry record establishes what the study intended to measure and how it planned to analyze that measure. It does not establish the size or precision of the Week 1 change. Interpretation should therefore remain limited to the study question and design rather than implying a finding about the effect of Voltaren Gel.
9. Statistical Methods Explained
The registry record identifies average MVPA minutes as a continuous outcome and describes analysis with a mixed model with repeated measures (MMRM). It defines the Week 1 change as the Week 1 average minus the baseline average. The baseline average uses MVPA minutes on non-missing days from Day -6 through Day 0. A positive value was defined as improvement. Although the outcome is described and the analysis method is named, the numerical estimate and model output are not reported in the registry record.
What does a repeated-measures model do?
In general, repeated-measures data contain multiple observations from the same participant over time. Those observations are usually related: a participant’s activity on one occasion may resemble their activity on another occasion more than it resembles another participant’s activity. A repeated-measures model accounts for that within-participant structure when estimating average patterns over time. This is a general explanation of the method, not a claim about the model’s exact specification in this study.
The registry record does not report the model’s fixed effects, covariance structure, estimation method, or any adjustment variables. Those details are not reported in the registry record. It also does not report the model-based estimate, standard error, confidence interval, or test result for the primary endpoint. Naming an MMRM does not by itself reveal the size, precision, or statistical significance of an estimated change.
How should continuous outcomes be read?
In general, a mean describes the average value in a group, while a standard deviation describes how spread out individual values are around that average. The primary outcome is expressed in minutes of MVPA, so an estimated change would retain a directly interpretable unit. The registry record identifies the measure as a mean with standard deviation, but the observed group summaries and change estimate are not reported in the registry record. No numerical interpretation of the primary outcome can therefore be made from the record.
In general, a confidence interval communicates uncertainty around an estimate. A narrower interval indicates greater precision under the analysis assumptions; a wider interval indicates more uncertainty. It is not a range that contains every participant’s response. The registry record does not report a confidence interval for the primary outcome. A p-value, if reported, would address compatibility of the data with a specified statistical null model under its assumptions; it would not measure the size or importance of a change. A primary-outcome p-value is not reported in the registry record.
Why do repeated observations and missing data matter?
In general, repeated activity measurements can vary from day to day, and some days may have no usable tracker data. A baseline average defined over non-missing days can consequently be based on different numbers of observed days across participants. How much this affects an estimate depends on the amount and pattern of missingness and on the analysis assumptions. The registry record defines baseline using non-missing days but does not report the number of missing tracker days, the amount of missing outcome data, or the assumptions and procedures used to handle missing values. Those details are not reported in the registry record.
In general, over-dispersion refers to variability greater than a statistical model assumes. It matters when the model’s assumed variability is too small, since uncertainty estimates and tests can then be misleading. The primary endpoint is a continuous measure analyzed with an MMRM; the record does not report an over-dispersion assessment, and the stated information does not establish that over-dispersion was relevant to this analysis. The more important reading point is that model diagnostics and the fit of the specified model are not reported in the registry record.
What does the planning information mean?
The record describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. The illustration is explicitly not the trial’s own design: the study itself was single group, with no two-arm allocation. The actual effect magnitude and calculated participant counts for the illustration are not reported in the registry record. Such counts are planning illustrations, not observed power and not evidence about the result of this study.
In general, power calculations concern the chance of detecting a specified effect under chosen assumptions and a statistical model. They do not tell readers the probability that a result is true, and post hoc calculations based on an observed estimate do not replace the estimate and its uncertainty. The planning description cannot resolve the absence of primary outcome results, nor can it make the single-group study a comparative trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 18 outcome measures and 39 analyses. It names the primary Week 1 MVPA change and multiple secondary outcomes, including step counts, sedentary and non-sedentary time, gait, morning mobility, and WOMAC physical function at Weeks 1, 2, and 3. MVPA on each day of the study is also listed. With multiple outcomes, time points, and analyses, there may be more than one opportunity to observe a statistically notable result. This is a general multiplicity concern; the presence of multiple analyses does not establish that any particular finding is false.
The registry record does not report whether a multiplicity adjustment was planned or used, how the primary endpoint was distinguished in formal testing from secondary endpoints, or whether analyses were designated as confirmatory or exploratory. These details are not reported in the registry record. Results for the listed secondary outcomes are also not reported in the registry record, so their relationship to the primary outcome cannot be assessed.
The primary analysis population is described as modified Intent-To-Treat. It included participants who met inclusion and exclusion criteria, used study product at least once, and had data from at least one post-baseline quality-of-life questionnaire supporting at least one secondary endpoint assessment. The number of participants included in the primary analysis, and the number contributing usable tracker measurements at each time point, are not reported in the registry record.
The record defines the baseline period using non-missing tracker days, but does not describe the extent or pattern of missing data, how missing Week 1 measurements were handled, or whether sensitivity analyses were conducted. These details are not reported in the registry record. In general, missingness can affect both the analyzed population and the interpretation of estimates, especially if the availability of measurements is related to participants’ activity or experience. The record does not provide enough detail to assess that possibility or the robustness of the analysis to missing data.
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 |
|---|---|---|---|
| Voltaren Gel | 0 | 196 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Voltaren Gel | 0 of 196 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Voltaren Gel | 17 of 196 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Voltaren Gel |
|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | 6 of 196 |
| Headache | Nervous system disorders | 3 of 196 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 1 of 196 |
| Myalgia | Musculoskeletal and connective tissue disorders | 1 of 196 |
| Ear infection | Infections and infestations | 1 of 196 |
| Sinusitis | Infections and infestations | 1 of 196 |
| Viral infection | Infections and infestations | 1 of 196 |
| Viral upper respiratory tract infection | Infections and infestations | 1 of 196 |
| Erythema | Skin and subcutaneous tissue disorders | 1 of 196 |
| Rash | Skin and subcutaneous tissue disorders | 1 of 196 |
The registry record lists 196 participants at risk for serious adverse events and 0 participants affected. It lists 196 participants at risk for other adverse events and 17 participants affected. The recorded number of deaths is 0. No serious adverse-event terms are listed in the registry record.
These are counts in the registry record, not comparative estimates. Because the study had a single group, the figures do not compare adverse events between Voltaren Gel and a control group. The record does not report event-level detail for the 17 participants, including event descriptions, severity, timing, or whether an event was considered related to study product. Those details are not reported in the registry record. The figures also do not establish whether all participants had the same duration of safety observation.
In general, adverse-event counts describe events recorded under a study’s reporting and observation procedures; they do not by themselves establish causation or rule out unrecorded events. The registry record’s serious and other adverse-event categories should be read as separate reported counts. No interpretation of their clinical significance beyond those recorded counts is supported by the information available.
12. What the Result Does, and Does Not, Mean
The study addresses a practical question: whether activity and mobility measures change over time among participants with knee osteoarthritis pain who use Voltaren Gel in a real-world evidence setting. Its primary endpoint uses tracker-measured MVPA minutes, and the record describes an analysis intended to assess change from baseline to Week 1. The design and endpoint are clearly described, but the numerical primary outcome is not reported in the registry record.
That absence matters. Without an estimated change and a measure of uncertainty, readers cannot determine the observed direction or size of the Week 1 difference, or how precisely it was estimated. The registry record’s definition that a positive change indicates improvement explains how a result would be interpreted; it does not show that a positive change occurred. Results for the listed mobility and quality-of-life measures are also not reported in the registry record.
Even if within-group changes were reported, this single-group design would not provide a direct comparison with no treatment or an alternative treatment. In general, a before-and-after change can reflect several influences occurring over the same period. The absence of a comparator means that the design cannot isolate the contribution of Voltaren Gel from those other influences. This is a limitation of the design, not a claim about the cause of any change.
The registry record does report safety counts: 0 participants affected by serious adverse events among 196 at risk, 17 affected by other adverse events among 196 at risk, and 0 deaths. These counts are descriptive. They do not, on their own, establish a causal relationship or characterize event severity, since those details are not reported in the registry record.
Accordingly, the record supports understanding the intended question, study structure, endpoint definition, and analysis approach. It does not support a conclusion about the magnitude, precision, or statistical significance of the primary outcome, nor a comparative conclusion about treatment effects.
13. Why This Trial Matters Statistically
This study illustrates the statistical distinction between describing change and estimating a comparative effect. The primary question concerns change in MVPA from baseline to Week 1, but the single-group design includes no control group. A within-group change can describe the trajectory among participants in the study; it cannot by itself show what would have happened to comparable participants without the intervention. That distinction is essential when interpreting real-world evidence.
The use of a connected activity tracker also highlights a measurement issue. Activity is recorded across days, and the baseline average is defined using non-missing days from Day -6 through Day 0. In general, device-based measures can provide repeated observations, but interpretation depends on data completeness and the rules used to summarize measurements. The record does not report how many tracker observations were missing or how missing data were handled beyond the baseline definition.
The endpoint is expressed as a continuous measure in minutes, and an MMRM is named for its analysis. This makes the planned approach recognizable, while the absence of estimates and uncertainty means that its practical result cannot be evaluated. Statistical methods are most informative when accompanied by effect estimates and measures of precision, not just the name of a model.
The record lists numerous outcomes and analyses, making the handling of multiple comparisons relevant to interpretation. It does not report whether any multiplicity strategy was used. Nor does it report the numerical primary or secondary results. These gaps prevent assessment of consistency across endpoints and time points.
Finally, the record’s planning illustration uses a two-arm framework despite the actual single-group design. It is explicitly a planning exercise rather than a feature of the study design. Keeping planning assumptions separate from observed analysis is important: an illustrative participant count cannot substitute for trial results or imply observed power.
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 lack of a comparator is a principal design limitation. Allocation is listed as not applicable, masking as none, and the model as single group. Consequently, the study does not offer a randomized or concurrent control comparison. Any change over time, if observed, could not be attributed uniquely to Voltaren Gel using this design alone.
The primary outcome result is not reported in the registry record. Neither the estimated Week 1 change nor its precision is available, and the listed secondary outcomes do not have numerical results in the registry record. This prevents evaluation of the magnitude, uncertainty, and consistency of outcome findings.
The registry record describes tracker-based measurement and a baseline definition using non-missing days, but does not report participant-level data completeness, the number of participants contributing to the primary analysis, or missing-data handling details. It also does not report adherence to gel use or tracker wear. These omissions limit assessment of measurement completeness and the analyzed sample.
The record does not provide detailed model specifications, model diagnostics, or the adjustment strategy for multiple outcomes and analyses. Those details are not reported in the registry record. Participant characteristics and further information needed to assess how well the enrolled group represents the broader population of people with knee osteoarthritis pain are also not reported in the registry record.
Safety information is presented as aggregate counts, without event descriptions, severity, timing, or product-relatedness detail. The registry record does not report the observation duration for adverse events or detailed safety methods. The counts should therefore be interpreted as a limited description rather than a complete characterization of safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Real-World Evidence Study to Evaluate the Effects of Voltaren Use on Mobility and Quality of Life in Participants With Knee Osteoarthritis Pain — NCT06379893.
- Registry record last updated 2026-01-20; status last verified 2026-01.
- Results first posted 2026-01-20.
- 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
The registry record describes a completed prospective Phase 4 real-world evidence study of Voltaren Gel in participants with knee osteoarthritis pain. It enrolled 196 participants and used a single-group design, with no comparator. Participants were instructed to apply the gel daily and wear an Actigraph wrist device for up to 21 days.
The primary endpoint was change from baseline in average MVPA minutes at Week 1, analyzed using an MMRM. The record defines positive change as improvement but does not report the primary outcome estimate, its uncertainty, or a p-value. It lists 18 outcome measures and 39 analyses, while numerical results for the primary and secondary outcomes are not reported in the registry record.
Safety counts include 0 serious adverse-event participants among 196 at risk, 17 participants with other adverse events among 196 at risk, and 0 deaths. The design and results available in the record do not support a comparative treatment-effect conclusion.