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Sponsored by: |
Grünenthal GmbH |
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Information provided by: | Grünenthal GmbH |
ClinicalTrials.gov Identifier: | NCT00472303 |
The Purpose of this study is to determine whether CG5503 is effective and safe in the treatment of chronic tumor related pain compared to placebo. In addition CG5503 will also be compared to morphine SR.
Condition | Intervention | Phase |
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Tumor Pain |
Drug: CG5503 ER Drug: Placebo to match CG5503 Drug: Morphine Sulphate CR Drug: Placebo to match Morphine Sulphate CR |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Withdrawal, Active- and Placebo-Controlled, Double-Blind, Multi-Center Phase III Trial Assessing Safety and Efficacy of Oral CG5503 PR* in Subjects With Moderate to Severe Chronic Malignant Tumor-Related Pain |
Estimated Enrollment: | 573 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Entering the titration phase subjects will be randomized into either ARM A or ARM C, with a ratio of 2:1 respectively. In the maintenance phase subjects in ARM A will be re-randomized into either ARM A or ARM B, with a ratio of 1:1.
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Drug: CG5503 ER
Tablet taken orally, twice daily, morning & evening with preferably 12 hrs (not less than 6 hrs) between doses. Titration phase: Starting at 100 mg, increasing at a minimum of 3 day intervals by 50 mg, with a maximum dose of 250 mg. Maintenance phase: continuing on dose level established in titration phase.
Drug: Placebo to match Morphine Sulphate CR
Capsule taken orally, twice daily, morning & evening with preferably 12 hrs (not less than 6 hrs) between doses
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B: Placebo Comparator
In the maintenance phase subjects in ARM A will be re-randomized into either ARM A or ARM B with a ratio of 1:1.
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Drug: Placebo to match CG5503
Tablet taken orally, twice daily, morning & evening with preferably 12 hrs (not less than 6 hrs) between doses
Drug: Placebo to match Morphine Sulphate CR
Capsule taken orally, twice daily, morning & evening with preferably 12 hrs (not less than 6 hrs) between doses
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C: Active Comparator
Entering the titration phase subjects will be randomized into either ARM A or ARM B, with a ratio of 2:1 respectively. In the maintenance phase subjects in ARM C will continue in ARM C
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Drug: Placebo to match CG5503
Tablet taken orally, twice daily, morning & evening with preferably 12 hrs (not less than 6 hrs) between doses
Drug: Morphine Sulphate CR
Capsule taken orally, twice daily, morning & evening with preferably 12 hrs (not less than 6 hrs) between doses. Titration phase: Starting at 40 mg, increasing at a minimum of 3 days intervals by 20 mg, with a maximum dose of 100 mg. Maintenance phase: continuing on dose level established in titration phase.
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Normally chronic tumor related 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 prolonged release (PR) 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 PR compared with no drug (placebo) and corresponding dose of morphine (an opioid commonly used to treat tumor related 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.
The trial includes a 2 week titration phase starting with either 40 mg morphine (PR) bid or 100 mg CG5503 PR bid. Based on effectiveness and side effects subjects can up-titrate in steps of 50 mg CG5503 PR (20 mg morphine PR) to a maximal dose of 250 mg CG5503 PR bid or 100 mg morphine PR bid. If subjects meet the stabilisation criteria at the end of the titration phase they will be re-randomized to either placebo or active treatment and will continue 4 weeks at the last dose level in the maintenance phase.
Assessments of pain relief include the pain intensity numeric rating scale (NRS), 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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Key Exclusion Criteria:
Contact: Claudia Leinweber | +49 (0)241-569 ext 2509 | Clinical-Trials@grunenthal.com |
Principal Investigator: | Hans Georg Kress, Dr. | Clinic of Anaesthesiology and Pain Management, AKH Vienna |
Responsible Party: | Grünenthal GmbH ( Grünenthal GmbH ) |
Study ID Numbers: | 761101 |
Study First Received: | May 10, 2007 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00472303 |
Health Authority: | Bulgaria: Bulgarian Drug Agency; Czech Republic: State Institute of Drug Control; Hungary: National Institute of Pharmacy; Poland: Central Register of Clinical Trials; Romania: National Medicines Agency; Russia: The Ministry of Health and Scocial Development of the Russian Federation; Serbia: Medicines and Medical Devices Agency of Sebia; Slovakia: State Institute of Drug control; Germany: Bundesinstitut für Arzneimittel und Medizinprodukte; Austria: Österreichische Agentur für Gesundheit und Ernährungssicherheit; Switzerland: Swissmedic, Schweizerisches Heilmittelinstitut; Italy: Local Hospital Boards only; Croatia: Ministry of Health and Social Welfare; Spain: Agencia Espanola de Medicamentos y Productos Sanitarios |
Opioid Central acting analgesic CG5503 PR Tumor related pain |
Cancer related pain Morphine Pain assessment Placebo |
Morphine Pain |
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 |