Phase 3
N=198
A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis
Pharyngitis
Bottom Line
View on ClinicalTrials.gov: NCT01048866 ↗Enrolled (actual)
198
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24) — -522.9; -326.5 units on a scale — p=0.0021
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- placebo (Drug); flurbiprofen (Drug); acetaminophen 650mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Reckitt Benckiser LLC
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24) |
-522.9; -326.5 | 0.0021 sig |
| SECONDARY Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline |
-37.1; -18.1 | 0.0002 sig |
| SECONDARY Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline |
-555.5; -379.4 | 0.0054 sig |
| SECONDARY Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline |
-35.5; -16.9 | 0.0008 sig |
| SECONDARY Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline |
-542.4; -377.4 | 0.0087 sig |
| SECONDARY Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2) |
-37.1; -17.9 | <0.0001 sig |
| 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 |
-476.9; -351.3 | 0.1844 |
| SECONDARY Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose |
9.9; 38.1; 28.7; 22.7; 27.7; 17.5 | <0.0001 sig |
| SECONDARY Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose |
25.0; 25.3; 27.0; 29.5; 26.0; 24.2 | 0.8827 |
| SECONDARY Participant Satisfaction Score 24 Hours After Initial Dose |
4.0; 5.2; 4.0; 9.4; 10.9; 14.6 | 0.0105 sig |
| SECONDARY Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7) |
19.8; 25.0; 22.9; 26.1; 24.0; 20.7 | — |
| SECONDARY Post 24 Hour, Multiple Dose Results: Weighted Sum of Pain Intensity Differences (SPID) Over 2 Hours for the Sore Throat Pain Intensity Scale (STPIS SPID2) |
-22.7; -16.8 | 0.0743 |
| SECONDARY Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Difficulty Swallowing Scale (DSS2) |
-21.0; -15.5 | 0.0871 |
| SECONDARY Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Swollen Throat Scale (SwoTS2) |
-19.5; -13.4 | 0.0595 |
| SECONDARY Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing |
9.7; 23.0; 21.7; 24.8; 25.2; 19.0 | 0.0195 sig |
| SECONDARY Percentage of Participants Who Took Rescue Pain Medication |
13.9; 25.8; 86.1; 74.2 | 0.0322 sig |
| SECONDARY Time to First Rescue Pain Medication |
2.0; 6.2; 2.0; 2.1; 5.9; 13.4 | 0.0276 sig |
| SECONDARY Change From Baseline in Body Temperature at 2 Hours Post Initial Dose |
-0.2; -0.0 | 0.0288 sig |
| SECONDARY Change From Baseline in Body Temperature at End of Study |
-0.4; -0.3 | 0.4274 |
Summary
The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen lozenge throughout the course of treating sore throat due to acute pharyngitis.
Eligibility Criteria
Inclusion Criteria
- The patient has a complaint of sore throat.
- If the patient is a female of childbearing potential, she has been using effective contraception since the last date of menses and is not breast-feeding or lactating.
- If the patient is a female of childbearing potential, the patient must have a negative urine pregnancy.
- The patient has provided written informed consent prior to any study-related procedures.
Exclusion Criteria
- The patient has a history of an upper gastrointestinal ulcer within the past 60 days, is currently experiencing clinically significant upper gastrointestinal complaints, or is currently taking medication regularly (≥ three times in the previous week).
- The patient has a history of any hepatic disease or renal dysfunction.
- The patient has a history of chronic analgesic use (≥ three times per week over the prior four weeks). (Patients on low-dose aspirin therapy may be allowed in the study per investigator's clinical decision.)
Data sourced from ClinicalTrials.gov (NCT01048866). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.