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Study Comparing the Efficacy ofTwo Ibuprofen Formulations
This study has been completed.
First Received: August 22, 2008   Last Updated: November 14, 2008   History of Changes
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:


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