Study Comparing the Efficacy of Two Ibuprofen Formulations

NCT00740857

Last updated date
Study Location
Salt Lake City, Utah, 84124, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16-40 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

:

- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Comparing the Efficacy of Two Ibuprofen Formulations
Official Title  ICMJE A Study Comparing the Efficacy of Two Ibuprofen Formulations
Brief Summary This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: placebo
    2 placebo gels capsules delivered as a single dose.
  • Drug: ibuprofen Formulation 1
    2 marketed ibuprofen gels
  • Drug: ibuprofen Formulation 2
    2 marketed ibuprofen gels
Study Arms  ICMJE
  • Placebo Comparator: 1
    Intervention: Drug: placebo
  • Active Comparator: 2
    Intervention: Drug: ibuprofen Formulation 1
  • Active Comparator: 3
    Intervention: Drug: ibuprofen Formulation 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2010)
211
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2008)
230
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 16 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00740857
Other Study ID Numbers  ICMJE PV-08-24
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP