Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00399659 |
This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation (OIC) in patients with non-cancer pain.
Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis (IA) receive the treatment as follows: Patients on tegaserod 6 mg twice daily (b.i.d.) or 12 mg once daily (o.d.) in the core study will remain on the same dose in the extension (double-blind). Patients on placebo during the core study will receive tegaserod 12 mg o.d. (open-label)
Patients who enter this study AFTER the core study interim analysis will receive the selected tegaserod dose regimen (open-label) determined by the core study IA.
Condition | Intervention | Phase |
---|---|---|
Opioid-Induced Constipation |
Drug: Tegaserod |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 52-Week Extension to Study CHTF919N2201 to Evaluate the Safety and Efficacy of Tegaserod (6 mg b.i.d. and 12 mg o.d.) Given Orally for the Treatment of Opioid-Induced Constipation (OIC) in Patients With Chronic Non-Cancer Pain |
Estimated Enrollment: | 360 |
Study Start Date: | November 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Study Chair: | Novartis Pharmaceuticals Corp. | NPC |
Study ID Numbers: | CHTF919N2201E1 |
Study First Received: | November 14, 2006 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00399659 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Opioid, constipation, tegaserod |
Serotonin Agonists Signs and Symptoms Neurotransmitter Agents Signs and Symptoms, Digestive Constipation Central Nervous System Depressants |
Pain Peripheral Nervous System Agents Analgesics Serotonin Analgesics, Opioid Tegaserod |
Serotonin Agonists Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Signs and Symptoms, Digestive Physiological Effects of Drugs Central Nervous System Depressants Pharmacologic Actions Signs and Symptoms Serotonin Agents |
Sensory System Agents Therapeutic Uses Constipation Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid Tegaserod |