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Sponsors and Collaborators: |
Grünenthal GmbH Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Grünenthal GmbH |
ClinicalTrials.gov Identifier: | NCT00609466 |
The main objective of this trial is to demonstrate the efficacy and safety of multiple-dose application of oral application of CG5503 IR 75mg compared to placebo and to assess safety and tolerability of CG5503 IR 75mg in subjects following bunionectomy.
Condition | Intervention | Phase |
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Bunionectomy Pain Assessment Post-Operative Pain Acute Pain |
Drug: CG5503 IR Drug: Morphine Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Parallel-Group, Multi-Center, Active- and Placebo-Controlled Trial to Evaluate the Analgesic Efficacy and Safety of Multiple Doses of CG5503 IR for Postoperative Pain Following Bunionectomy |
Estimated Enrollment: | 279 |
Study Start Date: | September 2007 |
Study Completion Date: | February 2008 |
Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: CG5503 IR
75mg IR 4 - 6 hourly Total: 72 hours
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2: Active Comparator |
Drug: Morphine
Morphine 30 mg IR 4 - 6 hourly Total: 72 hours
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3: Placebo Comparator |
Drug: Placebo
Placebo; 4 - 6 hourly; Total: 72 hours
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Subjects undergoing bunionectomy often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when subjects receive repeated doses of opioid analgesics. However, opoid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. CG5503, a newly synthesized drug with an immediate release (IR) formulation, also acts as a centrally acting pain reliever but has a dual mode of action. The aim of this trial is to investigate the effectiveness (level of pain control) and safety (side effects) of CG5503 IR 75mg compared with no drug (placebo) or one dose of morphine (an opoid commonly used to treat post-surgical pain). This trial is a randomized, double-blind (neither investigator nor patient will know which treatment was received), active- and placebo-controlled, parallel-group, multicenter trial to evaluate the treatment of acute pain after bunionectomy. The trial will include a blinded 72 hour inpatient phase immediately following bunionectomy, during which subjects will be treated with either 75-mg CG5503 IR, a placebo, or 20-mg morphine, and pain relief will be periodically assessed. Assessments of pain relief include the pain intensity numeric rating scale (PI), pain relief numeric rating scale (PAR), and patient global impression of change scale (PGIC). Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Venous blood samples will be collected for the determination of serum concentrations of CG5503 and morphine. The alternative trial hypothesis is that at least 1 dose strength of CG5503 will be different from placebo in controlling pain at 48 hours.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Site 104 | |
Pasadena, Maryland, United States, 21122 | |
United States, Texas | |
Site 101 | |
Austin, Texas, United States, 78705 | |
Site 102 | |
Houston, Texas, United States, 77081 | |
Site 103 | |
San Marcos, Texas, United States, 78666 | |
Site 105 | |
San Antonio, Texas, United States, 78229 | |
United States, Utah | |
Site 106 | |
Salt Lake City, Utah, United States, 84117 |
Principal Investigator: | Stephen Daniells, MD | Scirex Clinical Research Center |
Responsible Party: | Grünenthal GmbH ( Grünenthal GmbH ) |
Study ID Numbers: | 574139 |
Study First Received: | January 24, 2008 |
Last Updated: | February 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00609466 |
Health Authority: | United States: Food and Drug Administration |
Opioid Central acting analgesic CG5503 IR post-operative pain |
Bunionectomy Morphine Placebo |
Morphine Signs and Symptoms Postoperative Complications Pain Pain, Postoperative |
Pathologic Processes Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |