Trial · NCT01049334
A Study of Flurbiprofen 8.75 mg Lozenge in Patient With Pharyngitis
NCT01049334, 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 Patient With Pharyngitis. Trials, record NCT01049334. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01049334
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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 Patient With Pharyngitis
- NCT number
- NCT01049334
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 204 participants, actual
- Lead sponsor
- Reckitt Benckiser LLC
- Conditions
- Pharyngitis
- Interventions
- Placebo, Flurbiprofen
- First posted
- 2010-01-14
- Last updated
- 2017-09-21
- Results first posted
- 2017-09-21
Source ClinicalTrials.gov
Registered outcomes16
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), 24 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2; every 30 minutes until hour 6; and every hour the participant was awake between hours 7-24) | 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 -114609 (complete pain relief within 2 minutes of dosing that lasts 24 hours) to 29191 (maximum pain within 2 minutes 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 Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2) | baseline (pre-dose), 2 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2) | 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 dosing. The full range was -9405 (complete pain relief within 2 minutes of dosing that lasts 2 hours) to 2395 (maximum pain within 2 minutes 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 Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline | baseline (pre-dose), 2 hours post-dose (every 10 minutes until hour 2) | Participants were asked to evaluate his/her difficulty swallowing (dysphagia) using a 100-mm visual analog scale at Baseline and 2 hours post dose. 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 no difficulty and 100-mm indicated very difficult. Data is reported as the sum of the time-weighted pain intensity differences from baseline until 2 hours post dose. The full range was -9192 (no difficulty swallowing within 10 minutes of dosing that lasts 2 hours) to 2808 (maximum difficulty swallowing within 10 minutes 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), 24 hours post-dose (every 10 minutes until hour 2, every 30 minutes until hour 6, hourly from 7-24 hours) | Participants were asked to evaluate his/her difficulty swallowing (dysphagia) using a 100-mm visual analog scale at Baseline and until 24 hours post dose. 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 no difficulty and 100-mm indicated very difficult. Data is reported as the sum of the time-weighted pain intensity differences from baseline until 24 hours post dose. The full range was -110304 (no difficulty swallowing within 10 minutes of dosing that lasts 24 hours) to 33696 (maximum difficulty swallowing within 10 minutes lasting 24 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 Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline | baseline (pre-dose), 2 hours post-dose (at 1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, and 2 hours) | The participant was asked to evaluate how swollen his/her throat felt using a 100-mm visual analog scale at Baseline and at 1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, and 2 hours. The patient was 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 -9336 (throat did not feel swollen at all within 1 hour of dosing and lasted 2 hours) to 2664 (maximum swollen throat reported within 1 hour and lasting 2 hours) using the mean baseline SwoTS. |
| Secondary | Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline | baseline (pre-dose), 24 hours post-dose (1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, 2 hours, 2½ hours, 3 hours, 3½ hours, 4 hours, 4½ hours, 5 hours, 5½ hours, and 6 hours after the first dose, hourly from 7-24 hours) | The participant was asked to evaluate how swollen his/her throat felt using a 100-mm visual analog scale at Baseline and specified timeframes until 24 hours. The patient was 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 -112032 (throat did not feel swollen at all within 1 hour of dosing and lasted 24 hours) to 31968 (maximum swollen throat reported within 1 hour and lasting 24 hours) using the mean baseline SwoTS. |
| Secondary | Change From Baseline at 24 Hours in the Tonsillo-Pharyngitis Assessment (TPA) Scores in Participants With Baseline TPA Scores >=8 | Baseline (pre-dose), 24 hours post-dose | Tonsillo-Pharyngitis Assessment, or TPA, is an index of seven clinical features of the pain-producing condition itself, pharyngeal inflammation. The clinical features concern temperature, oropharyngeal color, size of tonsils, number of enanthems, largest size of cervical lymph node, number of lymph nodes, and maximum tenderness of lymph nodes. Each variable was rated on a scale of 0-3, with 0 representing the normal value, and 3 representing severe inflammation. The seven values are added together to create the TPA, ranging from 0-21. Negative change values represent improvement of symptoms. |
| Secondary | Practitioner's Assessment of Pharyngeal Inflammation (P.A.I.N.) Scores at 24 Hours After Initial Dose | 24 hours post-dose | P.A.I.N is a four step scale in which physicians rate the severity of pharyngeal inflammation: No inflammation, mild, moderate and severe inflammation. |
| 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 Scores 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 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
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), 24 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2; every 30 minutes until hour 6; and every hour the participant was awake between hours 7-24) | Intent to treat population of participants who took the first full dose of medication. Three participants (1 Flurbiprofen, 2 Placebo) did not have sufficient 24 hour data to be included in the primary analysis of the primary endpoint (no entries after 2 hours), but did have sufficient data to be included in other efficacy analyses. | units on a scale | LEAST_SQUARES_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), 2 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2) | 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 2 Hours From Baseline | baseline (pre-dose), 2 hours post-dose (every 10 minutes until hour 2) | 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), 24 hours post-dose (every 10 minutes until hour 2, every 30 minutes until hour 6, hourly from 7-24 hours) | Intent to treat population of participants who took the first full dose of medication and had DSS recorded after 21-hours. | 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), 2 hours post-dose (at 1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, and 2 hours) | 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), 24 hours post-dose (1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, 2 hours, 2½ hours, 3 hours, 3½ hours, 4 hours, 4½ hours, 5 hours, 5½ hours, and 6 hours after the first dose, hourly from 7-24 hours) | Intent to treat population of participants who took the first full dose of medication, and had SwoTS recorded after 21 hours. Four participants (1 Flurbiprofen, 3 Vehicle) did not have SwoTS recorded after 21 hours and were not included in the analysis. | units on a scale | MEAN |
| SECONDARY | Change From Baseline at 24 Hours in the Tonsillo-Pharyngitis Assessment (TPA) Scores in Participants With Baseline TPA Scores >=8 | Baseline (pre-dose), 24 hours post-dose | Intent to treat population of participants whose baseline TPA was \>=8 and had an assessment at hour 24. | units on a scale | MEAN |
| SECONDARY | Practitioner's Assessment of Pharyngeal Inflammation (P.A.I.N.) Scores at 24 Hours After Initial Dose | 24 hours post-dose | Intent to treat population. Three participants withdrew before the 24 hour assessment. | 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. Three participants withdrew before the 24 hour assessment. | percentage of participants | NUMBER |
| SECONDARY | Participant Satisfaction Scores 24 Hours After Initial Dose | 24 hours | Intent to treat population. Three participants withdrew before the 24 hour assessment. | percentage of participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group114
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 | -473.7 | Standard Error 45.4428 | 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 | -322.3 | Standard Error 45.6708 | units on a scale | |
| Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2) | Flurbiprofen 8.75 mg Lozenge | -43.4 | Standard Deviation 39.20 | units on a scale | |
| Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2) | Placebo Lozenge | -23.5 | Standard Deviation 29.52 | 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 | -39.1 | Standard Deviation 38.64 | units on a scale | |
| Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline | Placebo Lozenge | -16.6 | Standard Deviation 29.34 | 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 | -460.8 | Standard Deviation 498.79 | units on a scale | |
| Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline | Placebo Lozenge | -274.3 | Standard Deviation 455.35 | 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 | -39.9 | Standard Deviation 39.63 | units on a scale | |
| Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline | Placebo Lozenge | -20.1 | Standard Deviation 27.28 | units on a scale |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 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 | 102 | |
| Overall Study | STARTED | Placebo Lozenge | 102 | |
| Overall Study | COMPLETED | Flurbiprofen 8.75 mg Lozenge | 93 | |
| Overall Study | COMPLETED | Placebo Lozenge | 95 | |
| Overall Study | NOT COMPLETED | Flurbiprofen 8.75 mg Lozenge | 9 | |
| Overall Study | NOT COMPLETED | Placebo Lozenge | 7 |
Source ClinicalTrials.gov
Adverse events108
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 | Tinnitis | Ear and labyrinth disorders | Flurbiprofen 8.75 mg Lozenge | 1 | 102 | |
| other | Tinnitis | Ear and labyrinth disorders | Placebo Lozenge | 0 | 102 | |
| other | Conjunctivitis | Ear and labyrinth disorders | Flurbiprofen 8.75 mg Lozenge | 1 | 102 | |
| other | Conjunctivitis | Ear and labyrinth disorders | Placebo Lozenge | 1 | 102 | |
| other | Ocular hyperaemia | Ear and labyrinth disorders | Flurbiprofen 8.75 mg Lozenge | 1 | 102 | |
| other | Ocular hyperaemia | Ear and labyrinth disorders | Placebo Lozenge | 0 | 102 | |
| other | Abnormal sensation in eye | Ear and labyrinth disorders | Flurbiprofen 8.75 mg Lozenge | 0 | 102 | |
| other | Abnormal sensation in eye | Ear and labyrinth disorders | Placebo Lozenge | 1 | 102 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Flurbiprofen 8.75 mg Lozenge | 3 | 102 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo Lozenge | 0 | 102 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 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 | 36 | 102 |
| Total, other adverse events | Placebo Lozenge | 33 | 102 |
| Total, serious adverse events | Flurbiprofen 8.75 mg Lozenge | 0 | 102 |
| Total, serious adverse events | Placebo Lozenge | 0 | 102 |
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.
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