Trial · NCT01048866
A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis
NCT01048866, Phase 3, Completed, Reckitt Benckiser LLC; results first posted 2017-09-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis. Trials, record NCT01048866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01048866
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis
- NCT number
- NCT01048866
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 198 participants, actual
- Lead sponsor
- Reckitt Benckiser LLC
- Conditions
- Pharyngitis
- Interventions
- placebo, flurbiprofen, acetaminophen 650mg
- First posted
- 2010-01-14
- Last updated
- 2017-09-21
- Results first posted
- 2017-09-21
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24) | baseline (pre-dose), post-dose - hourly up to 24 hours | STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID24 was calculated as the sum of the time weighted pain intensity differences from baseline until 24 hours. The full range was -104412 (complete pain relief within 1 hour of dosing that lasts 24 hours) to 27588 (maximum pain within 1 hour lasting 24 hours) using the mean baseline STPIS. Participants with a last recorded time point \<21 hours were considered Not Evaluable. If a participant used rescue medication, all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose. |
| Secondary | Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline | Baseline (pre-dose), Hours 1 and 2 post-dose | DSS measures difficulty swallowing (dysphagia) using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and "Place a line on the scale that best characterizes how difficult it is to swallow now." A mark at 0-mm indicated not difficult and 100-mm indicated very difficult. Data are reported as the sum of the time-weighted pain intensity differences from baseline until 2 hours post dose. The full range was -9360 (no difficulty swallowing within 1 hour of dosing that lasts 2 hours) to 2640 (maximum difficulty swallowing within 1 hour of dosing lasting 2 hours) using the baseline DSS value. Missing values of DSS with non-missing values at assessments before and after were calculated using linear interpolation. |
| Secondary | Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline | Baseline (pre-dose), hourly readings to 24 hours post-dose | DSS measures difficulty swallowing (dysphagia) using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and "Place a line on the scale that best characterizes how difficult it is to swallow now." A mark at 0-mm indicated not difficult and 100-mm indicated very difficult. Data are reported as the sum of the time-weighted pain intensity differences from baseline until 24 hours post dose. The full range was -102960 (no difficulty swallowing within 1 hour of dosing that lasts 24 hours) to 29040 (maximum difficulty swallowing within 1 hour of dosing lasting 24 hours) using the baseline DSS value. Negative values indicate improvement in difficulty swallowing. Missing values of DSS with non-missing values at assessments before and after were calculated using linear interpolation. |
| Secondary | Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline | Baseline (pre-dose), hourly readings to 2 hours post-dose | SwoTS measures how swollen a participant's throat felt using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and "Place a line on the scale that best characterizes how swollen your throat feels now." A mark at 0-mm indicated not swollen and 100-mm indicated very swollen. The full range of the sum of the time-weighted swollen throat differences from baseline until 2 hours was -9120 (throat did not feel swollen at all within 1 hour of dosing and lasted 2 hours) to 2880 (maximum swollen throat reported within 1 hour and lasting 2 hours) using the mean baseline SwoTS. Negative values for the differences indicate improvement. Missing values of SwoTS with non-missing values at assessments before and after were calculated using linear interpolation. |
| Secondary | Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline | Baseline (pre-dose), hourly readings to 24 hours post-dose | SwoTS measures how swollen a participant's throat felt using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and "Place a line on the scale that best characterizes how swollen your throat feels now." A mark at 0-mm indicated not swollen and 100-mm indicated very swollen. The full range of the sum of the time-weighted swollen throat differences from baseline until 24 hours was -100320 (throat did not feel swollen at all within 1 hour of dosing and lasted 24 hours) to 31680 (maximum swollen throat reported within 1 hour and lasting 24 hours) using the mean baseline SwoTS. Negative values for differences indicate improvement. |
| Secondary | Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2) | baseline (pre-dose), post-dose: 1 hour, 2 hours | STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID2 was calculated as the sum of the time weighted pain intensity differences from baseline until 2 hours post dose. The full range was -9492 (complete pain relief within one hour of dosing that lasts 2 hours) to 2508 (maximum pain within 1 hour lasting 2 hours) using the mean baseline STPIS. If a participant used rescue medication (acetaminophen 650mg was allowed as needed post dose), all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments (recorded or derived due to rescue) were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose. |
| Secondary | Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale Over 24 Hours Post-baseline (STPIS SPID24) For Participants With Baseline Practitioner's Assessment of Pharyngeal Inflammation (PAIN) of Moderate or Severe | baseline (pre-dose), 24 hours post dose (measured each hour post dose) | STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. For the subgroup of patients with moderate/severe pharyngeal inflammation at baseline, SPID24 was calculated as the sum of the time weighted pain intensity differences from baseline until 24 hours. Taking inclusion criteria into account, the full range was -115695 (no pain at any post-dose time (0) - average baseline) to 28505 (maximum possible pain (100) - average baseline). Participants with their last recorded time point \<21 hours were considered Not Evaluable. If a participant used rescue medication, all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imput |
| Secondary | Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose | 2 hours | Participants graded the relief of his/her sore throat at 2 hours post initial dose using the Sore Throat Relief Rating Scale (STRRS), which is a 6-category relief scale. The patient was instructed to swallow and asked: "Considering how your throat felt before you took the study medicine, circle the phrase that best describes the relief of your sore throat now." Responses were no relief, slight, mild, moderate, considerable, and complete relief. |
| Secondary | Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose | 24 hours | Investigators assessed the effectiveness of study medication on the patient's sore throat at 24 hours following initial dose by answering the following question: "Considering the patient's response to the study medicine over the past 24 hours, how do you rate the study medicine as a treatment for sore throat?" Responses were poor, fair, good, very good or excellent. |
| Secondary | Participant Satisfaction Score 24 Hours After Initial Dose | 24 hours | After 24 hours of treatment, participants rated their satisfaction with the treatment on a 7-step scale from extremely dissatisfied to extremely satisfied. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24) | baseline (pre-dose), post-dose - hourly up to 24 hours | Intent to treat population of participants who took the first full dose of medication, and had STPIS values recorded \>= 21 hours post initial dose. Four participants (2 Flurbiprofen, 2 placebo) did not have sufficient 24 hour data to be included in the primary analysis of the primary endpoint. | units on a scale | MEAN |
| SECONDARY | Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline | Baseline (pre-dose), Hours 1 and 2 post-dose | Intent to treat population of participants who took the first full dose of medication | units on a scale | MEAN |
| SECONDARY | Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline | Baseline (pre-dose), hourly readings to 24 hours post-dose | Intent to treat population. Four participants (2 Flurbiprofen and 2 placebo) did not have DSS recorded after 21 hours and were not included in the analysis. | units on a scale | MEAN |
| SECONDARY | Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline | Baseline (pre-dose), hourly readings to 2 hours post-dose | Intent to treat population of participants who took the first full dose of medication | units on a scale | MEAN |
| SECONDARY | Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline | Baseline (pre-dose), hourly readings to 24 hours post-dose | Intent to treat population. Four participants (2 Flurbiprofen, 2 Vehicle) did not have SwoTS recorded after 21 hours and were not included in the analysis. | units on a scale | MEAN |
| SECONDARY | Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2) | baseline (pre-dose), post-dose: 1 hour, 2 hours | Intent to treat population | units on a scale | MEAN |
| SECONDARY | Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale Over 24 Hours Post-baseline (STPIS SPID24) For Participants With Baseline Practitioner's Assessment of Pharyngeal Inflammation (PAIN) of Moderate or Severe | baseline (pre-dose), 24 hours post dose (measured each hour post dose) | Intent to treat population of participants who took the first full dose of medication and had moderate or severe pharyngeal inflammation at baseline. | units on a scale | MEAN |
| SECONDARY | Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose | 2 hours | Intent to treat population | percentage of participants | NUMBER |
| SECONDARY | Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose | 24 hours | Intent to treat population. CLIN was not performed for 3 participants (1 Flurbiprofen, 2 placebo). | percentage of participants | NUMBER |
| SECONDARY | Participant Satisfaction Score 24 Hours After Initial Dose | 24 hours | Intent to treat population. One placebo participant did not complete a Patient Satisfaction Score. | percentage of participants | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24) | Flurbiprofen 8.75 mg Lozenge | -522.9 | Standard Deviation 476.54 | units on a scale | |
| Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24) | Placebo Lozenge | -326.5 | Standard Deviation 386.83 | units on a scale | |
| Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline | Flurbiprofen 8.75 mg Lozenge | -37.1 | Standard Deviation 39.60 | units on a scale | |
| Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline | Placebo Lozenge | -18.1 | Standard Deviation 29.43 | units on a scale | |
| Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline | Flurbiprofen 8.75 mg Lozenge | -555.5 | Standard Deviation 494.04 | units on a scale | |
| Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline | Placebo Lozenge | -379.4 | Standard Deviation 397.66 | units on a scale | |
| Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline | Flurbiprofen 8.75 mg Lozenge | -35.5 | Standard Deviation 38.92 | units on a scale | |
| Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline | Placebo Lozenge | -16.9 | Standard Deviation 29.10 | units on a scale | |
| Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline | Flurbiprofen 8.75 mg Lozenge | -542.4 | Standard Deviation 487.67 | units on a scale | |
| Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline | Placebo Lozenge | -377.4 | Standard Deviation 419.95 | units on a scale |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 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 | 97 | |
| Overall Study | COMPLETED | Flurbiprofen 8.75 mg Lozenge | 97 | |
| Overall Study | COMPLETED | Placebo Lozenge | 92 | |
| Overall Study | NOT COMPLETED | Flurbiprofen 8.75 mg Lozenge | 4 | |
| Overall Study | NOT COMPLETED | Placebo Lozenge | 5 |
Source ClinicalTrials.gov
Adverse events90
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 | Lacrimation increased | Eye disorders | Flurbiprofen 8.75 mg Lozenge | 0 | 101 | |
| other | Lacrimation increased | Eye disorders | Placebo Lozenge | 1 | 97 | |
| other | Vision blurred | Eye disorders | Flurbiprofen 8.75 mg Lozenge | 0 | 101 | |
| other | Vision blurred | Eye disorders | Placebo Lozenge | 1 | 97 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Flurbiprofen 8.75 mg Lozenge | 1 | 101 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo Lozenge | 1 | 97 | |
| other | Aphthous stomatitis | Gastrointestinal disorders | Flurbiprofen 8.75 mg Lozenge | 1 | 101 | |
| other | Aphthous stomatitis | Gastrointestinal disorders | Placebo Lozenge | 1 | 97 | |
| other | Diarrhoea | Gastrointestinal disorders | Flurbiprofen 8.75 mg Lozenge | 2 | 101 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Lozenge | 1 | 97 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 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 | 34 | 101 |
| Total, other adverse events | Placebo Lozenge | 28 | 97 |
| Total, serious adverse events | Flurbiprofen 8.75 mg Lozenge | 0 | 101 |
| Total, serious adverse events | Placebo Lozenge | 0 | 97 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT01048866
GET https://conductscience.org/api/trials/v1/NCT01048866/results?page=2