Study Comparing the Efficacy of Two Ibuprofen Formulations
A Study Comparing the Efficacy of Two Ibuprofen Formulations
1 other identifier
interventional
211
1 country
1
Brief Summary
This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 pain
Started Aug 2008
Shorter than P25 for phase_4 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 22, 2008
CompletedFirst Posted
Study publicly available on registry
August 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
August 12, 2010
CompletedJune 6, 2011
June 1, 2011
3 months
August 22, 2008
October 30, 2009
June 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Meaningful Pain Relief
Subjects evaluated the time to "First Perceptible" Relief by depressing a stopwatch at the moment they first began to experience "perceptible" relief and the time to "Meaningful" Relief by depressing a second stopwatch at the moment they first began to experience "meaningful" relief. These times were recorded up to 6 hrs after dosing. Range: up to 6 hrs, a lower number is better.
0-6 hours
Secondary Outcomes (7)
Pain Intensity Difference (PID) Scores at Each Individual Time Points
0-6 hours
Pain Relief (PR) Scores at Individual Time Points
0-6 hours
Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours
0-2 and 0-6 hours
Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points
0-6 hours
Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours
0-2 and 0-6 hours
- +2 more secondary outcomes
Study Arms (3)
1
PLACEBO COMPARATOR2
ACTIVE COMPARATOR3
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Salt Lake City, Utah, 84124, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- U. S. Contact Center
- Organization
- Wyeth
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 22, 2008
First Posted
August 25, 2008
Study Start
August 1, 2008
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
June 6, 2011
Results First Posted
August 12, 2010
Record last verified: 2011-06