Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain
NCT01512160
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- Oral surgical procedure having removed 2 third molars (unilateral).
- Pre-dose pain intensity score (100 mm Visual Analog Scale [VAS]) >50 mm within 5 hours of oral surgery.
- Pre-dose pain intensity score of moderate or within 5 hours of oral surgery.
- Presence or history of any significant hepatic, renal, endocrine, cardiovascular,
neurological (including subjects with a history of frequent moderate to severe
headaches or subjects with episodic migraines more than twice per month), psychiatric,
gastrointestinal, pulmonary, hematologic, or metabolic disorder.
- Prior use of any type of analgesic or NSAID within five half-lives of that drug or
less before taking the first dose of study medication, except for anesthesia for the
procedure.
- Recent history of chronic analgesic or tranquilizer dependency.
- Active dental infection at the time of surgery.
- Any significant oral surgery complication at the time of surgery or in the immediate
postoperative period or dental surgery lasting > 30 minutes.
- Subjects who are smokers.
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Descriptive Information | ||||
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Brief Title ICMJE | Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain | |||
Official Title ICMJE | A Randomized, Double-Blind Third Party Open, Double-Dummy, Parallel Group, Placebo Controlled Study Assessing The Efficacy Of Single Doses Of Pf-04531083 For The Treatment Of Post-Surgical Dental Pain Using Ibuprofen 400 Mg As A Positive Control | |||
Brief Summary | The purpose of this study is to evaluate the overall pain relief of a single dose of PF-04531083 against placebo following third molar extraction. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Post-surgical Dental 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 | Terminated | |||
Actual Enrollment ICMJE | 90 | |||
Original Estimated Enrollment ICMJE | 140 | |||
Actual Study Completion Date ICMJE | May 2012 | |||
Actual Primary Completion Date | March 2012 (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 | 18 Years to 55 Years (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 | NCT01512160 | |||
Other Study ID Numbers ICMJE | B1351010 | |||
Has Data Monitoring Committee | Yes | |||
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 | May 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |