A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Pharyngitis

In brief

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.

Key facts

Study ID

NCT01048866

Run by

Reckitt Benckiser LLC

People needed

198

Starts

2009-11-01

Expected to finish

2011-03-01

Last updated by the study team

2017-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.)

Where it is running

• Bluestone Center for Clinical Research — New York, New York, United States

Full record on ClinicalTrials.gov

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