Trial · NCT01986361
Placebo-Controlled Onset-of-Action Study of Flurbiprofen Utilizing the Double-Stopwatch Method
NCT01986361, Phase 3, Completed, Reckitt Benckiser LLC; results first posted 2017-08-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Placebo-Controlled Onset-of-Action Study of Flurbiprofen Utilizing the Double-Stopwatch Method. Trials, record NCT01986361. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01986361
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Placebo-Controlled Onset-of-Action Study of Flurbiprofen Utilizing the Double-Stopwatch Method
- NCT number
- NCT01986361
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 122 participants, actual
- Lead sponsor
- Reckitt Benckiser LLC
- Conditions
- Acute Pharyngitis, Sore Throat
- Interventions
- flurbiprofen, placebo
- First posted
- 2013-11-18
- Last updated
- 2017-09-28
- Results first posted
- 2017-08-24
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Kaplan-Meier Estimates for Time to Meaningful Pain Relief | up to 3 hours post dose on Day 1 | Time to meaningful pain relief is a patient-reported outcome (PRO) captured as part of the double stopwatch method. Participants depress the second stop watch when they experience what they perceive as meaningful pain relief. Instructions to participants are: "Stop the second stopwatch when the sore throat pain relief is meaningful to you. This does not mean you feel completely better, although you might, but when you feel relief of throat pain that is meaningful to you." Participants who did not have perceived pain relief were censored at 3 hours. |
| Secondary | Kaplan-Meier Estimates for Time of First Perceived Pain Relief | up to 3 hours post dose on Day 1 | Time to first perceived pain relief is a patient-reported outcome (PRO) captured as part of the double stopwatch method. Participants depress the first stop watch when they experience any pain relief, termed "perceived pain relief". Instructions to participants are: "Stop the first stopwatch when you first feel any sore throat pain relief whatsoever. This does not mean you feel completely better, although you might, but when you first feel any relief of the throat pain you have now." Participants who did not have perceived pain relief were censored at 3 hours. |
| Secondary | Kaplan-Meier Estimates for Time to First Perceived Pain Relief That Is Confirmed By Meaningful Pain Relief | up to 3 hours post dose on Day 1 | Time to first perceived pain relief on the first stopwatch that was confirmed by meaningful pain relief on the second stopwatch. Participants who had no meaningful pain relief within 3 hours from baseline were censored to 3 hours. |
| Secondary | Kaplan-Meier Estimates for Time of First Indication of Sore Throat Relief as Measured By Any Reduction in the Sore Throat Scale (STS) | up to 3 hours post dose on Day 1 | Time to first indication of sore throat relief, defined as any reduction or decrease in STS observed during the 3 hours post dose. Participants who did not have any reduction in STS from baseline within 3 hours were censored to 3 hours. The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: "Circle the number that shows how sore your throat is now when you swallow." The STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours. |
| Secondary | Kaplan-Meier Estimates for Time of First Perceived Pain Reduction on the Sore Throat Scale (STS) Which is Followed by ≥ 20% Pain Reduction on the Sore Throat Pain Intensity Scale (STPIS) | Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1 | Time to pain reduction on the STS (defined as any reduction or decrease observed during the 3 hours post dose) for participants whose improvement was confirmed by a \>=20% reduction in pain on the STPIS. STS: The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: "Circle the number that shows how sore your throat is now when you swallow." The STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours. STPIS: The participant was instructed to swallow and: "Place a line on the Sore Throat Scale that best characterizes the severity of your sore throat now:" 0mm=no pain and 100mm=severe pain. The STPIS was obtained at baseline, after the participant depressed the second stopwatch, and at 1, 2, and 3 hours postdose. |
| Secondary | Change From Baseline at Individual Timepoints in Sore Throat Scale (STS) | Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1 | The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: "Circle the number that shows how sore your throat is now when you swallow." The STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours. |
| Secondary | Percentage of Participants With Meaningful Pain Relief | up to 3 hours post dose on Day 1 | Defined as the percentage of participants who pressed the second stopwatch during the 3 hour evaluation period. |
| Secondary | Percentage of Participants With Perceived Pain Relief | up to 3 hours post dose on Day 1 | Defined as the percentage of participants who pressed the first stopwatch during the 3 hour evaluation period. |
| Secondary | Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Scale (STS) Over the 3 Hours Post-baseline (STS SPID3) | Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1 | The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: "Circle the number that shows how sore your throat is now when you swallow." STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours, for a total of 24 post-dose measurements. The time-weighted SPID combines relief magnitude (PID = change from baseline) as weighted by duration interval between ratings. SPID3 refers to measurements taken up to 3 hours post-baseline, and has a full range of -1332 (complete pain relief within 5 minutes of dosing that lasts for 3 hours) to 468 (drug escalates level of pain to a score of 10 and the pain stays at that level for 3 hours) using the mean baseline STS value 7.4 for this study. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Kaplan-Meier Estimates for Time to Meaningful Pain Relief | up to 3 hours post dose on Day 1 | Intent to treat population | minutes | MEDIAN |
| SECONDARY | Kaplan-Meier Estimates for Time of First Perceived Pain Relief | up to 3 hours post dose on Day 1 | Intent to treat | minutes | MEDIAN |
| SECONDARY | Kaplan-Meier Estimates for Time to First Perceived Pain Relief That Is Confirmed By Meaningful Pain Relief | up to 3 hours post dose on Day 1 | Intent to treat | minutes | MEDIAN |
| SECONDARY | Kaplan-Meier Estimates for Time of First Indication of Sore Throat Relief as Measured By Any Reduction in the Sore Throat Scale (STS) | up to 3 hours post dose on Day 1 | Intent to treat | minutes | MEDIAN |
| SECONDARY | Kaplan-Meier Estimates for Time of First Perceived Pain Reduction on the Sore Throat Scale (STS) Which is Followed by ≥ 20% Pain Reduction on the Sore Throat Pain Intensity Scale (STPIS) | Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1 | Intent to treat | minutes | MEDIAN |
| SECONDARY | Change From Baseline at Individual Timepoints in Sore Throat Scale (STS) | Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1 | Intent to treat | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With Meaningful Pain Relief | up to 3 hours post dose on Day 1 | Intent to treat | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Perceived Pain Relief | up to 3 hours post dose on Day 1 | Intent to treat | percentage of participants | NUMBER |
| SECONDARY | Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Scale (STS) Over the 3 Hours Post-baseline (STS SPID3) | Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1 | Intent to treat | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Kaplan-Meier Estimates for Time to Meaningful Pain Relief | Flurbiprofen 8.75 mg Lozenge | 42.917 | 95% Confidence Interval 36.367 to 49.383 | minutes | |
| Kaplan-Meier Estimates for Time to Meaningful Pain Relief | Placebo Lozenge | NA | 95% Confidence Interval 47.567 to NA | minutes | |
| Kaplan-Meier Estimates for Time of First Perceived Pain Relief | Flurbiprofen 8.75 mg Lozenge | 10.867 | 95% Confidence Interval 7.633 to 14.283 | minutes | |
| Kaplan-Meier Estimates for Time of First Perceived Pain Relief | Placebo Lozenge | 19.317 | 95% Confidence Interval 4.783 to 30.333 | minutes | |
| Kaplan-Meier Estimates for Time to First Perceived Pain Relief That Is Confirmed By Meaningful Pain Relief | Flurbiprofen 8.75 mg Lozenge | 13.200 | 95% Confidence Interval 8.633 to 16.567 | minutes | |
| Kaplan-Meier Estimates for Time to First Perceived Pain Relief That Is Confirmed By Meaningful Pain Relief | Placebo Lozenge | NA | 95% Confidence Interval 6.633 to NA | minutes | |
| Kaplan-Meier Estimates for Time of First Indication of Sore Throat Relief as Measured By Any Reduction in the Sore Throat Scale (STS) | Flurbiprofen 8.75 mg Lozenge | 15.000 | 95% Confidence Interval 10.000 to 15.000 | minutes | |
| Kaplan-Meier Estimates for Time of First Indication of Sore Throat Relief as Measured By Any Reduction in the Sore Throat Scale (STS) | Placebo Lozenge | 20.000 | 95% Confidence Interval 5.000 to 30.000 | minutes | |
| Kaplan-Meier Estimates for Time of First Perceived Pain Reduction on the Sore Throat Scale (STS) Which is Followed by ≥ 20% Pain Reduction on the Sore Throat Pain Intensity Scale (STPIS) | Flurbiprofen 8.75 mg Lozenge | 15.000 | 95% Confidence Interval 10.000 to 20.000 | minutes | |
| Kaplan-Meier Estimates for Time of First Perceived Pain Reduction on the Sore Throat Scale (STS) Which is Followed by ≥ 20% Pain Reduction on the Sore Throat Pain Intensity Scale (STPIS) | Placebo Lozenge | NA | 95% Confidence Interval 10.000 to NA | minutes |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Flurbiprofen 8.75 mg Lozenge | 101 | |
| Overall Study | STARTED | Placebo Lozenge | 21 | |
| Overall Study | COMPLETED | Flurbiprofen 8.75 mg Lozenge | 101 | |
| Overall Study | COMPLETED | Placebo Lozenge | 21 | |
| Overall Study | NOT COMPLETED | Flurbiprofen 8.75 mg Lozenge | 0 | |
| Overall Study | NOT COMPLETED | Placebo Lozenge | 0 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | Flurbiprofen 8.75 mg Lozenge | 1 | 101 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo Lozenge | 0 | 21 | |
| other | Diarrhoea | Gastrointestinal disorders | Flurbiprofen 8.75 mg Lozenge | 1 | 101 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Lozenge | 0 | 21 | |
| other | Nausea | Gastrointestinal disorders | Flurbiprofen 8.75 mg Lozenge | 2 | 101 | |
| other | Nausea | Gastrointestinal disorders | Placebo Lozenge | 0 | 21 | |
| other | Dizziness | Nervous system disorders | Flurbiprofen 8.75 mg Lozenge | 1 | 101 | |
| other | Dizziness | Nervous system disorders | Placebo Lozenge | 0 | 21 | |
| other | Headache | Nervous system disorders | Flurbiprofen 8.75 mg Lozenge | 1 | 101 | |
| other | Headache | Nervous system disorders | Placebo Lozenge | 1 | 21 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Flurbiprofen 8.75 mg Lozenge | ||
| Total, all-cause mortality | Placebo Lozenge | ||
| Total, other adverse events | Flurbiprofen 8.75 mg Lozenge | 10 | 101 |
| Total, other adverse events | Placebo Lozenge | 1 | 21 |
| Total, serious adverse events | Flurbiprofen 8.75 mg Lozenge | 0 | 101 |
| Total, serious adverse events | Placebo Lozenge | 0 | 21 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29381110 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Flurbiprofen 8.75 mg Lozenge vs Placebo Lozenge: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01986361
GET https://conductscience.org/api/trials/v1/NCT01986361/results?page=2