A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Reckitt Benckiser LLC
• Treatments: Acetaminophen; Flurbiprofen

Criteria

Inclusion Criteria:

1. The patient has a complaint of sore throat.

2. 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.

3. If the patient is a female of childbearing potential, the patient must have a negative urine pregnancy.

4. The patient has provided written informed consent prior to any study-related procedures.

Exclusion Criteria:

1. 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).

2. The patient has a history of any hepatic disease or renal dysfunction.

3. 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.)