A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis
Information source: Reckitt Benckiser LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pharyngitis
Intervention: Placebo (Drug); Flurbiprofen (Drug)
Phase: Phase 3
Sponsored by: Reckitt Benckiser LLC
Official(s) and/or principal investigator(s):
Timothy J Shea, BS, Study Director, Affiliation: Reckitt Benckiser LLC
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.
Official title: A Repeat-Dose, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Study to Determine the Safety and Efficacy of Flurbiprofen 8.75 mg Lozenge Compared to Its Vehicle Control Lozenge in Patients With Painful Pharyngitis
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: The primary Outcome Measure in this trial will be efficacy for Sore Throat Pain during the first 24 hours.
Secondary outcome: The Secondary Outcome Measure in this trial will be efficacy for Sore Throat Pain during the first 2 hours.
Minimum age: 18 Years.
Maximum age: N/A.
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
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.)
Locations and Contacts
Bluestone Center for Clinical Research, New York, New York 10010, United States
Starting date: November 2009
Last updated: April 1, 2011