Study Comparing the Efficacy of Two Ibuprofen Formulations
NCT00740857
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
:
- 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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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 211 | |||
Original Estimated Enrollment ICMJE | 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 :
Exclusions criteria:
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Sex/Gender ICMJE |
| |||
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 |
| |||
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 |