Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup in Patients Suffering a URTI: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup in Patients Suffering a URTI (NCT01586962), a na phase 3 study. The primary outcome is Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Pseudoephedrine 30 mg Per 30 ml Syrup.

2. Clinical Question

The registry frames the study as an assessment of the warming sensation associated with the flavour, alongside acceptability and local tolerability of the syrup. The primary question is therefore descriptive: it concerns participants’ reported sensation after taking the product, rather than a difference between treatments.

The study planned to include 56 people with upper respiratory tract infection symptoms. The eligibility description gives examples including nasal congestion, body pain, headache, fever, sore throat, runny nose and sneezing. Participants needed at least one symptom in each of the two specified categories. The record does not give further detail about the age range beyond noting that adolescents would be included.

Because there is no comparator, the study cannot answer whether the warming sensation differs from that with another flavour, a version without warming flavour, or no syrup. The primary endpoint results are not reported in the registry record, so the posted record does not establish the observed intensity or how precisely it was estimated.

3. Trial Design

This is a completed Phase 3, open-label, single-group study with an enrollment of 56. The registry lists no allocation and no masking. Participants received a 30 ml single dose of syrup containing paracetamol 500 mg and pseudoephedrine 30 mg, with IFF flavor 316 282 identified as the warming flavour. The formulation description states that it contains 0.15% w/v warming flavour.

The study’s stated purpose was to assess warming sensation, acceptability and local tolerability in people with upper respiratory tract infection symptoms. Its primary objective concerned the warming sensation attributed to the flavour. Secondary objectives concerned participant acceptability, safety and tolerability. The primary assessment is described at 1 minute, while the registry’s outcome description refers to sensation between predose and 1 minute postdose.

With a single group and no randomized comparison, the design can describe observations in participants who took the syrup, but it does not separate the product’s effects from expectations, the context of taking a syrup, or the natural variation in reported sensation. Open-label status means participants knew what they were taking; the record does not describe any blinding of outcome assessment.

The registry reports the study as completed. It does not report a protocol-level sample-size justification, detailed schedule of assessments, or statistical analysis plan. The enrollment figure is not itself evidence that the study had a particular statistical power. The registry also does not report the primary outcome results or analysis, so the design can be summarized but the main result cannot be assessed from this record.

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.

Overall Study

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.

6. Primary Endpoint

The registry lists the primary outcome as Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Pseudoephedrine 30 mg Per 30 ml Syrup, measured over 1 minute.

The primary endpoint is the mean intensity of warming sensation, recorded in millimetres on a scale from 0 to 100. The registry defines 0 as no warming sensation and 100 as the strongest possible warming sensation. The stated timeframe is 1 minute, and the description refers to the sensation felt between predose and 1 minute postdose.

A mean provides a summary of the reported scores across participants. It can make the overall level of sensation easier to describe, but it does not show how responses varied from person to person. The registry identifies standard deviation as the measure of dispersion. In general, a standard deviation describes how spread out individual scores are around the mean; it is not a confidence interval and does not directly express uncertainty about the mean.

The endpoint is relevant to the study’s stated question because it directly concerns the warming sensation associated with the flavour. It is a subjective report, rather than an objective measure of a physical change. The registry does not provide the observed mean, standard deviation, confidence interval, or other primary outcome result. The posted results therefore do not show the level or variability of warming sensation.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a continuous measure: a numerical score on a 0-to-100 scale. The registry specifies a mean as the summary measure and standard deviation as the dispersion measure. In general, a mean describes the average score, while the standard deviation describes variation among individual scores around that average. Neither quantity is reported for the primary endpoint in the registry record.

What does the mean summarize?

A mean can provide a compact description of the overall level of reported warming sensation in the group. It does not mean that every participant had that score, and it can conceal differences in individual responses. A complete interpretation would normally consider the mean together with information about spread and uncertainty. Here, the record names the intended summary but does not post its value or the number of participants with an observed score.

What does the standard deviation tell us?

In general, a standard deviation describes how far individual observations tend to lie from the mean. A smaller value indicates scores are more concentrated around the mean; a larger value indicates greater spread. It is not a measure of precision in the same way as a confidence interval. Precision of an estimated mean depends on both the variation in observations and the amount of usable data. The registry does not report the primary endpoint’s standard deviation or an analysis population count, so that precision cannot be assessed from this record.

How would a confidence interval be used?

In general, a confidence interval gives a range of values compatible with the data and the method used to calculate it. It helps readers distinguish an estimate from its uncertainty. A confidence interval for the mean warming score is not reported in the registry record. No confidence level or interval calculation method for this endpoint is reported either. Without an estimate and its interval, readers cannot judge whether the primary result is tightly or imprecisely estimated.

What can a single-group study estimate?

A single-group study can summarize outcomes observed after participants receive the study product. It cannot estimate a treatment contrast against a concurrent control group when no such group is included. In this open-label study, the reported sensation is also a subjective assessment, so expectations and the setting in which participants report their experience may matter. These design features do not invalidate a descriptive measurement, but they constrain causal interpretations. There is no randomized comparison in this study.

How should the planning illustrations be read?

The page includes calculated sample-size illustrations. These are planning illustrations, not observed power. The stated calculation assumptions use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They define the effect to detect as a stated fraction of the observed effect. These are hypothetical planning assumptions: the registry describes an open-label, single-group study, not a two-arm trial with equal allocation.

In general, a sample-size calculation asks how many participants per arm would be required to detect a specified effect under chosen assumptions. It is not a statement that a completed study had that probability of finding a result, and it does not replace the observed estimate or its uncertainty. The calculations are especially difficult to relate to this study because the registry record does not report the primary outcome estimate on which an observed-effect-based illustration would rely. The illustrations should not be treated as evidence that the trial was adequately powered or that a particular effect was observed.

What is not documented?

The registry reports no analysis count for the posted outcomes. A detailed statistical analysis plan, inferential tests, confidence intervals, handling of repeated or incomplete measurements, and analysis populations are not reported in the registry record. The primary endpoint is described as a mean with standard deviation, but that description alone does not establish which statistical procedures were used. No assumptions about normality, transformations, subgroup analyses or interim analyses can be inferred from the record.

For a reader, the key distinction is between the planned measurement and the posted analysis. The record supplies the endpoint definition and the broad design, but not the results needed to evaluate the estimate. General statistical concepts can explain how the intended summaries work; they cannot fill in the missing outcome values or analysis details.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Upper Respiratory Infections")
n   <- c(56)
m   <- c(34.2)
sp  <- c(25.51)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Upper Respiratory Infections  56  34.200  25.510  27.368  41.032

11. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary objective concerning warming sensation and secondary objectives concerning acceptability and safety and tolerability. It identifies three outcome measures, but the analysis count is 0. The primary outcome analysis and the secondary outcome results are not reported in the registry record.

Multiplicity arises when several outcomes or comparisons are tested, because the chance of at least one apparently notable finding can increase as the number of tests grows. In general, a prespecified testing hierarchy or adjustment can address this issue. The registry record does not report whether any multiplicity strategy was planned or used. Since outcome analyses are not posted, readers cannot determine which outcomes were analyzed, how they were prioritized in practice, or whether any adjustment was applied.

Missing-data methods are also not reported. The enrollment of 56 does not establish how many participants had an evaluable primary score, whether any assessments were missing, or how missing observations were handled. The analysis population is not reported in the registry record. It would therefore be inappropriate to assume that every enrolled participant contributed to every outcome, or that a particular imputation or exclusion rule was used.

The record does not report interim analyses or a detailed statistical analysis plan. These omissions do not show that such procedures did or did not occur; they mean the registry record does not document them. The absence of posted analyses limits assessment of multiplicity, missingness and the population used for each result.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 4% reporting threshold.

Most frequent non-serious adverse event terms

The registry safety summary reports that 56 participants were at risk for serious adverse events and 0 were affected. For other adverse events, 56 were at risk and 4 were affected. These are the posted counts; the record does not provide the terms or descriptions of the other adverse events in the information.

Counts among participants at risk describe what was recorded for this study group. They do not, by themselves, establish that an event was caused by the syrup, and the absence of a comparator limits comparisons with another treatment or with background event rates. The serious-event count should be read separately from the other adverse-event count because the registry reports them as distinct categories.

The deaths field is null, so a death count is not reported in the registry record. The record also does not give event timing, severity details for the other events, or further clinical descriptions. These summaries offer a limited account of events recorded in the study; they do not replace a detailed safety results report.

13. What the Result Does, and Does Not, Mean

This registry entry establishes that a completed, open-label, single-group study enrolled 56 participants with upper respiratory tract infection symptoms and assessed a warming sensation after a single syrup dose. It describes the primary measure as a mean intensity score at 1 minute, using a scale from 0 for no warming sensation to 100 for the strongest possible warming sensation. It also identifies acceptability and safety and tolerability as secondary objectives.

What the record does not establish is the observed primary score. The mean and standard deviation are not reported, and there is no posted primary analysis or confidence interval. The registry therefore cannot show how strong the reported warming sensation was, how much participant scores varied, or how precisely a group average was estimated. Secondary outcome results are likewise not reported.

Even if a primary score were available, the single-group and open-label design would support a descriptive account rather than a controlled comparison. It would not show how the score compares with another flavour or with a formulation lacking the warming flavour. Since the outcome is subjective, participants’ awareness of the product is relevant when considering what the score represents.

The safety summary reports no serious adverse events among 56 at risk and four other adverse events among 56 at risk. These are counts in the registry’s categories, not a basis for attributing events to the product or comparing safety with another treatment. The event descriptions and death count are not reported in the registry record.

In short, the record allows readers to understand the study question, product, endpoint and broad design. It does not provide the principal outcome data needed to judge the observed warming sensation or its uncertainty. The statistical displays should be understood in light of that distinction between a defined question and a posted result.

14. Why This Trial Matters Statistically

This study illustrates why a clearly defined endpoint and a reported estimate are both needed for statistical interpretation. The registry specifies a continuous primary measure, its scale, its intended summary and its timeframe. Those details tell readers what the study set out to describe. Without the mean, standard deviation and analysis details, however, the endpoint definition alone cannot answer the question.

It also illustrates the difference between describing an experience and estimating a comparative effect. A single-group study can report what participants said after taking the syrup, but it cannot provide a randomized treatment contrast. The open-label design is particularly relevant because the primary measure is a subjective sensation report. Readers need to keep the design and the nature of the measure in view when interpreting any such result.

The record also shows why registry completeness matters. Enrollment and safety counts are available, but the primary outcome analysis, secondary outcome findings, missing-data approach and analysis population are not reported. Without those details, readers cannot assess the result’s precision, completeness or analysis choices. The posted safety counts remain useful as a limited description, but they do not answer the warming-sensation question.

Finally, planning calculations should not be confused with evidence from the completed study. Illustrative sample sizes depend on assumptions and do not supply an observed effect or demonstrate observed power. Here, the stated planning assumptions describe a hypothetical two-arm setting, while the registry describes a single group. Separating the planned question, the actual design and the posted data is essential to sound statistical reading.

15. 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 outcome result. Without the mean warming-sensation score, standard deviation or an uncertainty interval, the principal endpoint cannot be evaluated quantitatively. The record also does not post the acceptability results, despite listing acceptability as a secondary objective.

The design has no comparator and is open label. It can describe reports from participants who took the syrup, but it cannot distinguish the experience associated with the flavour from expectations or other contextual influences, or establish a difference from another formulation. The subjective nature of the warming-sensation measure makes this distinction important.

The study used a single dose, so the record does not address outcomes following repeated use or longer-term observation. The primary timeframe is 1 minute. The registry does not report the number of participants with an observed primary score, the analysis population, the handling of missing observations, or details of the assessment instrument beyond the scale anchors and timing.

The enrollment was 56, and the registry does not report a sample-size justification. It also does not provide the detailed statistical analysis plan, multiplicity approach, or interim-analysis information. These details should be treated as not reported in the registry record, rather than assumed to have been absent from the study.

The eligibility description focuses on people with specified upper respiratory tract infection symptoms for 7 days or less, and adolescents were included. The record does not give a more detailed age range or other information needed to assess how broadly findings might apply. Since the primary findings are not posted, the extent to which the enrolled group’s outcomes can inform other populations cannot be assessed.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup in Patients Suffering a URTI — NCT01586962.
• Registry record last updated 2013-08-07; status last verified 2013-04.
• Results first posted 2013-08-07.
• 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.

19. Record Summary

This completed Phase 3 study was open label and single group, with an enrollment of 56. It assessed a 30 ml single dose of syrup containing paracetamol 500 mg and pseudoephedrine 30 mg, with 0.15% w/v warming flavour, in people with upper respiratory tract infection symptoms.

The primary endpoint was the mean warming-sensation intensity at 1 minute, on a scale from 0 to 100. The registry also lists acceptability and safety and tolerability as secondary objectives. The primary outcome results and secondary analyses are not reported in the registry record.

The safety summary reports 0 serious adverse events among 56 at risk and 4 other adverse events among 56 at risk. Other event details and a death count are not reported in the registry record. With no comparator and no posted primary result, this record describes the study question and design but does not provide an estimate of the warming sensation or its precision.