Efficacy Of PF-05089771 In Treating Postoperative Dental Pain
NCT01529346
ABOUT THIS STUDY
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- Oral surgery having removed 2 unilateral third molar teeth.
- Pre-dose pain intensity score (100 mm VAS [VAS]) of at least 50mm within 5 hours of oral surgery
- Pre-dose pain intensity score of moderate or severe within 5 hours of oral surgery
- Presence or known history of any clinically significant hematological, hepatic, renal,
endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary,
allergic (including known drug hypersensitivities or allergies, but excluding
untreated asymptomatic seasonal allergy) or any metabolic disorder that may increase
risk associated with study participation, investigational drug administration or may
interfere with interpretation of study results.
- Prior use of any type of analgesic or NSAID within 5-half lives of that drug or less
before taking the first dose of study medication, except for anesthesia for the
procedure.
- Active dental infection at the time of surgery.
- Recent (within the previous 12 months) history of chronic analgesic or tranquiliser
dependency.
- Any significant oral surgery complication at the time of surgery or in the immediate
postoperative period, or oral surgery that has lasted more than 30 minutes (time from
first incision to last suture placement).
Subjects who smoke more than 1 pack (20 cigarettes) per day, more than 3 cigars per day or
use smokeless tobacco on a daily basis are excluded from the study.
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Descriptive Information | ||||
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Brief Title ICMJE | Efficacy Of PF-05089771 In Treating Postoperative Dental Pain | |||
Official Title ICMJE | A Randomized, Double-blind, Double-dummy, Parallel Group, Placebo Controlled Study Assessing The Efficacy Of Single Doses Of Pf-05089771 For The Treatment Of Postoperative Dental Pain Using Ibuprofen 400 Mg As Positive Control | |||
Brief Summary | The objective of this study is to evaluate the overall pain relief of a single dose of PF-05089771 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 | Postoperative 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 | Completed | |||
Actual Enrollment ICMJE | 235 | |||
Original Estimated Enrollment ICMJE | 234 | |||
Actual Study Completion Date ICMJE | June 25, 2012 | |||
Actual Primary Completion Date | June 25, 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Subjects who smoke more than 1 pack (20 cigarettes) per day, more than 3 cigars per day or use smokeless tobacco on a daily basis are excluded from the study. | |||
Sex/Gender ICMJE |
| |||
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 | NCT01529346 | |||
Other Study ID Numbers ICMJE | B3291009 | |||
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 | May 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |