A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction
This study has been completed.
Sponsor:
Array BioPharma
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT00542035
First received: October 5, 2007
Last updated: January 6, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dental Pain |
Drug: ARRY-371797, p38 inhibitor; oral Drug: Placebo; oral |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
Further study details as provided by Array BioPharma:
Primary Outcome Measures:
- Assess the efficacy of the study drug dosed either perioperatively or postoperatively in terms of total pain relief (TOTPAR) and total pain intensity (visual analog scale, VAS). [ Time Frame: 6 hours post dose 2 ] [ Designated as safety issue: No ]
- Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Compare the efficacy of the study drug dosed perioperatively versus postoperatively in terms of total pain intensity (VAS). [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
| Enrollment: | 103 |
| Study Start Date: | October 2007 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ARRY-371797 |
Drug: ARRY-371797, p38 inhibitor; oral
dose 1, dose 2
|
| Experimental: Placebo, ARRY-371797 |
Drug: Placebo; oral
dose 1
Drug: ARRY-371797, p38 inhibitor; oral
dose 2
|
| Placebo Comparator: Placebo |
Drug: Placebo; oral
dose 1, dose 2
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Key Inclusion Criteria:
- 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 Exclusion Criteria:
- 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Array BioPharma |
| ClinicalTrials.gov Identifier: | NCT00542035 History of Changes |
| Other Study ID Numbers: | ARRAY-797-221 |
| Study First Received: | October 5, 2007 |
| Last Updated: | January 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Array BioPharma:
|
Analgesia |
Additional relevant MeSH terms:
|
Toothache Tooth Diseases Stomatognathic Diseases |
Facial Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013