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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: | NCT00478023 |
The main objective of this study is to demonstrate the efficacy and safety of multiple-dose application of three different oral doses of CG5503 IR compared to placebo and to assess safety and tolerability of CG5503 IR in women undergoing abdominal hysterectomy.
Condition | Intervention | Phase |
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Hysterectomy Abdominal Pain Assessment Visceral Pain |
Drug: Morphine Drug: CG5503 IR Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Parallel-Arm, Placebo- and Comparator- Controlled Trial of the Efficacy and Safety of Multiple Doses of Immediate-Release (IR) CG5503 for Postoperative Pain Following Abdominal Hysterectomy |
Enrollment: | 854 |
Study Start Date: | May 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: Active Comparator |
Drug: Morphine
20 mg IR; 4 - 6 hourly; Total 72 hours
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2: Experimental |
Drug: CG5503 IR
50mg; 4 - 6 hourly; Total 72 hours
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3: Experimental |
Drug: CG5503 IR
75mg; 4 -6 hourly; Total 72 hours
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4: Experimental |
Drug: CG5503 IR
100mg, 4 - 6 hourly; Total 72 hours
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5: Placebo Comparator |
Drug: Placebo
4 - 6 hourly; Total 72 hours
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Subjects undergoing abdominal hysterectomy often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when subjects receive repeated doses of opioid analgesics. However, opioid 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 study is to investigate the effectiveness (level of pain control) and safety (side effects) of 3 dose levels of CG5503 IR compared with no drug (placebo) or one dose of morphine (an opioid commonly used to treat post-surgical pain). This study is a randomized, double-blind (neither investigator nor patient will know which treatment was received), active- and placebo-controlled, parallel-group, multicenter study to evaluate the treatment of acute pain after abdominal hysterectomy. The study will include a blinded 72 hour inpatient phase immediately following hysterectomy, during which subjects will be treated with either 50-, 75-, or 100-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 study hypothesis is that at least 1 dose strength of CG5503 will be different from placebo in controlling pain at 24 hours.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Tomasz Rechberger, Prof. | Samodzielny Publiczny Szpital |
Responsible Party: | Grünenthal GmbH ( Grünenthal GmbH ) |
Study ID Numbers: | 731200 |
Study First Received: | May 23, 2007 |
Last Updated: | February 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00478023 History of Changes |
Health Authority: | Serbia: Medicines and Medical Devices Agency of Serbia; Croatia: Ministry of Health; Hungary: Hungarian National Institut of Pharmacy; Latvia: State Agency of Medicines; Poland: Minstry of Health and Social Welfare; Rumania: Minstry of Health; Russia: Minstry of Health Russia; Slovenia: Agency for medicinal prodcuts and medical devices; Slowakia: Statny pre kontrolu lieciv; Ukraine: Ministry of Health |
Opioid Central acting analgesic CG5503 IR Abdominal pain |
Hysterectomy Morphine Placebo |
Morphine Signs and Symptoms Signs and Symptoms, Digestive Abdominal Pain Central Nervous System Depressants Narcotics |
Pain Peripheral Nervous System Agents Analgesics Analgesics, Opioid Pain, Postoperative |
Morphine Signs and Symptoms, Digestive Abdominal Pain Physiological Effects of Drugs Central Nervous System Depressants Narcotics Pain Pharmacologic Actions |
Signs and Symptoms Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |