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Sponsored by: |
QRxPharma Inc. |
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Information provided by: | QRxPharma Inc. |
ClinicalTrials.gov Identifier: | NCT00565760 |
This is a Phase 3 double-blind, multiple dose safety extension study of Q8003 administered at daily doses up to 36 mg morphine/24 mg oxycodone (Q8003 36mg/24mg) over a treatment period of up to 4 weeks. Patients with acute moderate to severe pain who have completed participation in one of the designated QRxPharma, Inc. acute pain lead-in studies will be eligible for this trial.
Condition | Intervention | Phase |
---|---|---|
Acute Moderate to Severe Pain |
Drug: Q8003 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Double-Blind, Multi-Center Extension Study to Evaluate the Safety and Efficacy of Q8003 in Patients With Acute Moderate to Severe Pain |
Enrollment: | 16 |
Study Start Date: | November 2007 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Q8003
Capsules
|
2: Placebo Comparator |
Drug: Placebo
Capsules
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The currently designated acute pain lead-in study is Study Q8003-007, which is a safety and efficacy study of Q8003 in the management of post-bunionectomy pain.
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, Ph.D., Executive Vice President, Drug Development ) |
Study ID Numbers: | Q8003-010 |
Study First Received: | November 28, 2007 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00565760 |
Health Authority: | United States: Food and Drug Administration |
Acute Pain |
Pain |