Study Comparing the Efficacy of Two Ibuprofen Formulations
NCT00740857
Last updated date
ABOUT THIS STUDY
This is a study of healthy volunteers to compare how quickly different ibuprofen products
relieve dental pain.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
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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 |
| |||
| Study Arms ICMJE |
| |||
| 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:
| |||
| 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 | ||||