Text Size

A Study of Flurbiprofen 8.75 mg Lozenge in Patient With Pharyngitis

This study has been completed.
Sponsor:
Information provided by:
Reckitt Benckiser LLC
ClinicalTrials.gov Identifier:
NCT01049334
First received: January 13, 2010
Last updated: April 1, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Pharyngitis
 Drug: Placebo
Drug: Flurbiprofen
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Multiple-Dose Study to Determine the Efficacy, Onset, and Duration of Action of Flurbiprofen 8.75 mg Lozenge Compared to Its Vehicle Control Lozenge in Patients With Painful Pharyngitis

Resource links provided by NLM:

MedlinePlus related topics: Sore Throat
U.S. FDA Resources

Further study details as provided by Reckitt Benckiser LLC:

Primary Outcome Measures:
  • The primary Outcome Measure in this trial will be efficacy for Sore Throat Pain during the first 24 hours. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Secondary Outcome Measure in this trial will be efficacy for Sore Throat Pain during the first 2 hours. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: November 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Vehicle control lozenge
 Drug: Placebo
Suck one lozenge until gone, every 3-6 hours as needed for pain
Experimental: Active
Active Flurbiprofen lozenge
 Drug: Flurbiprofen
Suck one lozenge until gone, every 3-6 hours as needed for pain

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049334

Locations
United States, New York
Bluestone Center for Clinical Research
New York, New York, United States, 10010
Sponsors and Collaborators
Reckitt Benckiser LLC
Investigators
Study Director: Timothy J Shea, BS Reckitt Benckiser LLC
  More Information

No publications provided

Responsible Party: Clinical Trial Manager, Reckitt Benckiser Inc
ClinicalTrials.gov Identifier: NCT01049334     History of Changes
Other Study ID Numbers: TH 0901
Study First Received: January 13, 2010
Last Updated: April 1, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Flurbiprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013