|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | QRxPharma Inc. |
|---|---|
| Information provided by: | QRxPharma Inc. |
| ClinicalTrials.gov Identifier: | NCT00560183 |
Purpose
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 (morphine sulfate and oxycodone hydrochloride) Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
|---|---|
| Experimental: 1 |
Drug: Q8003 (morphine sulfate and oxycodone hydrochloride)
Capsules, four different mg dosage strengths
|
| Placebo Comparator: 2 |
Drug: Placebo
Capsules
|
This study is a randomized, double-blind, placebo-controlled, rising-dose/by-cohort study of the efficacy and safety of Q8003 in inpatients with acute pain following unilateral bunionectomy surgery. Patients in each dosing group will receive either Q8003 (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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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. |
More Information
| Responsible Party: | Warren Stern, Executive Vice President, Drug Development, QRxPharma Inc. |
| ClinicalTrials.gov Identifier: | NCT00560183 History of Changes |
| Other Study ID Numbers: | Q8003-007 |
| Study First Received: | November 14, 2007 |
| Last Updated: | August 30, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Acute Bunionectomy |
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Morphine Oxycodone Analgesics, Opioid Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics |