A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction
NCT00542035
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
- Scheduled for outpatient oral surgical procedure to remove 2 ipsilateral 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
- Positive urine drug screen.
- Use of prescription or nonprescription drugs, herbal or dietary supplements, vitamins,
or grapefruit juice within 14 days prior to first dose of study drug.
- Additional criteria exist.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Austin, Texas
- Salt Lake City, Utah
- San Marcos, Texas
- Salt Lake City, Utah
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction | ||||||
| Official Title ICMJE | Not Provided | ||||||
| Brief Summary | This is a Phase 2 study designed to test the ability of investigational study drug ARRY-371797 to reduce pain either perioperatively or postoperatively in a third molar extraction pain model, and to further evaluate the drug's safety. Approximately 150 subjects from the US will be enrolled in this study. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 2 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Supportive Care | ||||||
| Condition ICMJE | Dental 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 | 103 | ||||||
| Original Estimated Enrollment ICMJE | 150 | ||||||
| Actual Study Completion Date ICMJE | February 11, 2008 | ||||||
| Actual Primary Completion Date | February 11, 2008 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| Ages ICMJE | 18 Years and older (Adult, Older 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 | NCT00542035 | ||||||
| Other Study ID Numbers ICMJE | ARRAY-797-221 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE |
| ||||||
| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
| ||||||
| PRS Account | Pfizer | ||||||
| Verification Date | October 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||