| April 18, 2008 |
| June 20, 2008 |
| April 2008 |
| June 2008 (final data collection date for primary outcome measure) |
| Total pain relief (TOTPAR) through 6 hours following the first dose of study medication (DOSE 1) [ Time Frame: 6 hours post-dose ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00663767 on ClinicalTrials.gov Archive Site |
- Peak pain relief (PPR) relative to pre-DOSE 1, the highest pain-relief (PR) score achieved at any time point during the post DOSE 1 evaluation period prior to the receipt of DOSE 2 [ Time Frame: Any time point post-dose ] [ Designated as safety issue: No ]
- Time to perceptible PR following DOSE 1 [ Time Frame: Post-dose ] [ Designated as safety issue: No ]
- Time to meaningful PR following DOSE 1 [ Time Frame: Post-dose ] [ Designated as safety issue: No ]
- Time to onset of analgesia following DOSE 1 [ Time Frame: Post-dose ] [ Designated as safety issue: No ]
- Time to rescue medication following DOSE 1 [ Time Frame: Post-dose ] [ Designated as safety issue: No ]
- Patient's Global Evaluation of Study Medication [ Time Frame: 6 hours post DOSE 1 ] [ Designated as safety issue: No ]
- Symptom distress scale questionnaire score [ Time Frame: 24 hours post DOSE 1 ] [ Designated as safety issue: No ]
- Incidence and severity of adverse events [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
- Incidence and severity of clinical findings on physical examination [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
- Incidence and severity of clinical laboratory abnormalities [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
- Mean change from baseline in vital signs (blood pressure, temperature, pulse) [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
- Mean change from baseline in 12-lead ECG parameters [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| Analgesic Efficacy Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction |
| A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Analgesic Efficacy Trial of Oral ARRY-371797 in Subjects Undergoing Third Molar Extraction |
This study will allow us to expand our understanding of ARRY-371797 efficacy in a postoperative pain model by evaluating dose response relationship of ARRY-371797, and by comparing the onset, magnitude, and duration of ARRY-371797 efficacy to a marketed anti-inflammatory drug, celecoxib. The 400 mg dose was evaluated in the recently completed postoperative pain study ARRAY-797-221, thus the primary objective of the ARRAY-797-222 study is to confirm the efficacy of 400 mg ARRY-371797 compared to placebo. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Dental Pain |
- Drug: ARRY-371797
- Drug: Placebo
- Drug: Celecoxib
|
- Placebo Comparator: DOSE 1- Placebo, DOSE 2- Placebo
- Experimental: DOSE 1- Placebo, DOSE 2- 200 mg ARRY-371797
- Experimental: DOSE 1- 200 mg ARRY-371797, DOSE 2- Placebo
- Experimental: DOSE 1- 200 mg ARRY-371797, DOSE 2- 200 mg ARRY-371797
- Experimental: DOSE 1- 400 mg ARRY-371797, DOSE 2- Placebo
- Experimental: DOSE 1- 400 mg ARRY-371797, DOSE 2- 200 mg ARRY-371797
- Experimental: DOSE 1- 600 mg ARRY-371797, DOSE 2- Placebo
- Active Comparator: DOSE 1- 400 mg celecoxib, DOSE 2- Placebo
- Experimental: DOSE 1-400 mg celecoxib, DOSE 2- 200 mg ARRY-371797
|
| |
| |
| Completed |
| 250 |
| June 2008 |
| June 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 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 as outlined in the protocol from at least 14 days prior to the dosing of trial medication until the completion of the follow-up procedures;
- A non-clinically significant ECG at screening and prior to surgery on Day 1 with QTc interval ≤ 450 msec for each individual ECG;
- Body weight >50 kg (110 lbs);
- Good health determined by medical history, physical examination, vital signs and clinical laboratory results of non-clinical significance;
- Postsurgical pain rating of "moderate" or "severe" and VAS pain intensity ≥ 50 mm.
Exclusion Criteria:
- 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 dosing);
- Pregnancy or lactation;
- Positive urine drug screen at the screening visit;
- Use of prohibited prescription drugs, or grapefruit juice within 7 days of randomization; 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).
- Use of P450 CYP3A inducers including St John's Wort within 14 days of randomization.
|
| Both |
| 18 Years to 65 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00663767 |
| Cynthia L. Martinez, RN/Clinical Program Manager, Array BioPharma Inc. |
| ARRAY-797-222 |
| Array BioPharma |
|
| Principal Investigator: |
William L Buchanan, MD, DDS |
PPD Phase I Clinic |
|
|
| Array BioPharma |
| June 2008 |