Status:
COMPLETED
A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction
Lead Sponsor:
Pfizer
Conditions:
Dental Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a Phase 2 study designed to test the ability of investigational study drug ARRY-371797 to reduce pain in a postoperative pain model (third molar extraction), and to further evaluate the drug's...
Eligibility Criteria
Inclusion
- Key
- Scheduled for outpatient oral surgical procedure to remove 3 or more third molars, at least 1 of which is mandibular and fully or partially impacted by bone.
- Females of childbearing potential must be willing to use an acceptable method of contraception within 14 days prior to first dose of study drug until the completion of the follow-up procedures.
- Body weight \>50 kg (110 lbs).
- Good health determined by medical history, physical examination, vital signs and clinical laboratory results of non-clinical significance.
- Additional criteria exist.
- Key
Exclusion
- Evidence or history of clinically significant dermatologic, hematological, renal, endocrine (e.g. poorly controlled diabetes), pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, ophthalmologic, or allergic disease (including clinically significant drug allergies that could impact the conduct of this study, but excluding untreated, asymptomatic, seasonal allergies at time of study drug dosing).
- Positive urine drug screen within 28 days prior to first dose of study drug.
- Use of prohibited prescription drugs, or grapefruit juice within 7 days of first dose of study drug; prohibited medications are defined as nonsteroidal and steroidal antiinflammatory drugs, analgesics including opioids (except low dose aspirin for myocardial infarction prophylaxis), P450 CYP3A substrates or inhibitors (strong or moderate).
- Additional criteria exist.
Key Trial Info
Start Date :
April 7 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2008
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00663767
Start Date
April 7 2008
End Date
June 20 2008
Last Update
February 9 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
PPD Phase I Clinic
Austin, Texas, United States, 78744
2
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106