Study Comparing the Efficacy ofTwo Ibuprofen Formulations
Information source: Wyeth
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: placebo (Drug); ibuprofen Formulation 1 (Drug); ibuprofen Formulation 2 (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com
Summary
This is a study of healthy volunteers to compare how quickly different ibuprofen products
relieve dental pain.
Clinical Details
Official title: A Study Comparing the Efficacy ofTwo Ibuprofen Formulations
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: Time to meaningful pain relief
Secondary outcome: PID (pain intensity difference), PR (pain relief), SPRID from 0-2 hours and 0-6 hours, PRID, SPID, TOTPAR. Time to first perceptible relief.
Eligibility
Minimum age: 16 Years.
Maximum age: 40 Years.
Gender(s): Both.
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.
Locations and Contacts
Trial Manager, Email: clintrialparticipation@wyeth.com
Salt Lake City, Utah 84124, United States; Recruiting
Additional Information
Starting date: July 2008
Ending date: October 2008
Last updated: August 28, 2008
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