A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction
NCT00542035
ABOUT THIS STUDY
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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.
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction | ||||||
| Official Title ICMJE | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP ANALGESIC EFFICACY TRIAL OF ORAL ARRY-371797 IN SUBJECTS UNDERGOING THIRD MOLAR EXTRACTION | ||||||
| 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 |
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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 | 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:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older 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 | NCT00542035 | ||||||
| Other Study ID Numbers ICMJE | ARRAY-797-221 C4411008 ( Other Identifier: Alias Study Number ) | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE |
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| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Pfizer | ||||||
| Verification Date | February 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||