A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis

Launched by RECKITT BENCKISER LLC · Jan 13, 2010

Keywords

ClinConnect Summary

Per randomization to the treatments and under double-blind conditions, patients were instructed to suck 1 sugar-based, flavoured flurbiprofen 8.75 mg lozenge or 1 sugar-based, flavoured matching vehicle control/placebo lozenge and remained at the study center for a 2-hour observation period to assess their responses to the study medication during the initial 2-hour post-dose period. Patients were allowed a dose of rescue medication (acetaminophen 650mg), as needed, post-treatment dosing during the study.

After the initial 2 hours in the research center, patients were discharged with an out...

Gender

ALL

Eligibility 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.)