Phase 3
Completed N=204
A Study of Flurbiprofen 8.75 mg Lozenge in Patient With Pharyngitis
Source: ClinicalTrials.gov NCT01049334 ↗Enrolled (actual)
204
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24) — -473.7; -322.3 units on a scale — p=0.0201
◆ Published Evidence
Established
27citations · ~2 / year
Randomised, double-blind, placebo-controlled studies on flurbiprofen 8.75 mg lozenges in patients with/without group A or C streptococcal throat infection, with an assessment of clinicians' prediction of 'strep throat'.
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.
Linked Publications (2)
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Randomised, double-blind, placebo-controlled studies on flurbiprofen 8.75 mg lozenges in patients with/without group A or C streptococcal throat infection, with an assessment of clinicians' prediction of 'strep throat'.
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Efficacy of flurbiprofen 8.75 mg lozenge in patients with a swollen and inflamed sore throat.
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) |
-473.7; -322.3 | 0.0201 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) |
-43.4; -23.5 | <.0001 sig |
| SECONDARY Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline |
-39.1; -16.6 | <0.0001 sig |
| SECONDARY Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline |
-460.8; -274.3 | 0.0071 sig |
| SECONDARY Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline |
-39.9; -20.1 | <0.0001 sig |
| SECONDARY Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline |
-472.2; -355.2 | 0.0393 sig |
| SECONDARY Change From Baseline at 24 Hours in the Tonsillo-Pharyngitis Assessment (TPA) Scores in Participants With Baseline TPA Scores >=8 |
-1.2; -2.0 | 0.0459 sig |
| SECONDARY Practitioner's Assessment of Pharyngeal Inflammation (P.A.I.N.) Scores at 24 Hours After Initial Dose |
0; 1; 48; 42; 42; 50 | 0.8383 |
| SECONDARY Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose |
15.8; 38.0; 34.7; 28.0; 19.8; 18.0 | 0.0005 sig |
| SECONDARY Participant Satisfaction Scores 24 Hours After Initial Dose |
5.0; 10.0; 6.9; 20.0; 11.9; 14.0 | 0.0005 sig |
| SECONDARY Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at the End of the Study (Day 7) |
11.8; 31.6; 28.0; 34.7; 30.1; 14.7 | 0.0002 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 |
-451.4; -283.4 | 0.0435 sig |
| SECONDARY Sore Throat Relief Rating Scale (STRRS) At 2 Hours After Initial Dose |
18.6; 45.1; 23.5; 24.5; 23.5; 11.8 | <.0001 sig |
| SECONDARY Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05 |
-0.1; -0.2; -0.3; -0.4; -0.6; -0.8 | 0.1448 |
| SECONDARY Kaplan-Meier Estimates for Sore Throat Pain Intensity Scale (STPIS) Time to Definite Improvement |
NA; NA | 0.0273 sig |
| SECONDARY Kaplan-Meier Estimates for Sore Throat Pain Intensity Scale (STPIS) Time to Definite Improvement Duration of Relief Using Participant-Defined Definite Improvement Levels (DIL) |
75.2; 29.4 | 0.0098 sig |
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 (NCT01049334) and the linked publication. 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. Informational only — not medical advice.