Study Comparing the Efficacy ofTwo Ibuprofen Formulations - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00740857

Purpose

This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.

Condition	Intervention	Phase
Pain	Drug: placebo Drug: ibuprofen Formulation 1 Drug: ibuprofen Formulation 2	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	A Study Comparing the Efficacy ofTwo Ibuprofen Formulations

Resource links provided by NLM:

Drug Information available for: Ibuprofen

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Time to meaningful pain relief [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PID (pain intensity difference), PR (pain relief), SPRID from 0-2 hours and 0-6 hours, PRID, SPID, TOTPAR. Time to first perceptible relief. [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	230
Study Start Date:	July 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: placebo 2 placebo gels capsules delivered as a single dose.
2: Active Comparator	Drug: ibuprofen Formulation 1 2 marketed ibuprofen gels
3: Active Comparator	Drug: ibuprofen Formulation 2 2 marketed ibuprofen gels

Eligibility

Ages Eligible for Study:	16 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria :

Outpatients with post-operative pain following surgical extraction of third molars,
examined by the attending dentist or physician and medically cleared to participate in the study,
in general good health and have no contraindications to the study or rescue medication.

Exclusions criteria:

any serious medical condition,
acute localized dental infection at the time of surgery ,
females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740857

Locations

United States, Utah

Salt Lake City, Utah, United States, 84124

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	PV-08-24
Study First Received:	August 22, 2008
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00740857 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Wyeth:

Dental pain analgesia

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Ibuprofen
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010