Multiple Dose Dental Pain Study Of Ibuprofen Extended Release
NCT01266161
ABOUT THIS STUDY
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- Males and females 16 to 40 years of age
- Subjects who undergo surgical removal of at least two third molars
- One of which must be a partial or full bony mandibular impaction
- Subjects must have at least moderate baseline pain (a score of 2 on the categorical pain severity rating scale) confirmed by a score of at least 50 mm on the 100-mm visual analog scale-pain severity rating scale (VAS-PSR)
- Acute localized dental infection at the time of surgery that could confound the
post-surgical evaluation
- Presence or history of any significant organ disease
- Use of prescription or OTC first generation antihistamines
- Females who are pregnant, lactating or of childbearing potential and not using a
medically approved method to prevent pregnancy
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Multiple Dose Dental Pain Study Of Ibuprofen Extended Release | |||
Official Title ICMJE | A Multiple Dose Dental Pain Study Of An Ibuprofen 600 Mg Extended Release Caplet | |||
Brief Summary | The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide analgesic efficacy superior to placebo over 12-hour dosing intervals. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) 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 | 106 | |||
Original Estimated Enrollment ICMJE | 120 | |||
Actual Study Completion Date ICMJE | March 31, 2011 | |||
Actual Primary Completion Date | March 31, 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 16 Years to 40 Years (Child, Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
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 | NCT01266161 | |||
Other Study ID Numbers ICMJE | B3491001 AK-10-13 ( Other Identifier: Alias Study Number ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | August 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |