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Sponsored by: |
QRxPharma Inc. |
---|---|
Information provided by: | QRxPharma Inc. |
ClinicalTrials.gov Identifier: | NCT00560183 |
This study will explore the efficacy and safety of a fixed dose combination of morphine and oxycodone for management of acute postoperative pain. The study will explore the efficacy dose response and dosing interval required to maintain adequate analgesia at each tested dosage strength.
Condition | Intervention | Phase |
---|---|---|
Postoperative Pain |
Drug: Q8003 IR Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Placebo-Controlled, Randomized, Double-Blind Study of the Safety and Efficacy of Q8003 in the Management of Post-Bunionectomy Pain |
Enrollment: | 256 |
Study Start Date: | November 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Q8003 IR
Capsules, four different mg dosage strengths
|
2: Placebo Comparator |
Drug: Placebo
Capsules
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This study is a randomized, double-blind, placebo-controlled, rising-dose/by-cohort study of the efficacy and safety of Q8003 IR in inpatients with acute pain following unilateral bunionectomy surgery. Patients in each dosing group will receive either Q8003 IR (approximately 50 per dosing group) or placebo (approximately 13 per dosing group), determined by random sequential assignment and blinded to patients and managing Investigators. Dosing groups will be enrolled sequentially in ascending order; only one dosing group will be open at a time for enrollment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Advanced Clinical Research Institute | |
Anaheim, California, United States, 92801 | |
United States, Maryland | |
Chesapeake Research Group | |
Pasadena, Maryland, United States, 21122 | |
United States, Pennsylvania | |
Advanced Regional Center for Foot and Ankle Care | |
Altoona, Pennsylvania, United States, 16602 | |
United States, Texas | |
Scirex Research Center | |
Houston, Texas, United States, 77081 | |
United States, Utah | |
Lifetree Clinical Research | |
Salt Lake City, Utah, United States, 84106 | |
Jean Brown Research | |
Salt Lake City, Utah, United States, 84124 |
Study Director: | Warren Stern, Ph.D. | QRxPharma Inc. |
Responsible Party: | QRxPharma Inc. ( Warren Stern, Executive Vice President, Drug Development ) |
Study ID Numbers: | Q8003-007 |
Study First Received: | November 14, 2007 |
Last Updated: | April 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00560183 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Acute Bunionectomy |
Signs and Symptoms Postoperative Complications Pain Pain, Postoperative |
Signs and Symptoms Pathologic Processes Postoperative Complications Pain Pain, Postoperative |