Spots Global Cancer Trial Database for Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
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Trial Identification
Brief Title: Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
Official Title: An Open Label 52-week Study to Evaluate the Safety and Efficacy of Tegaserod Given Orally for the Treatment of Opioid-induced Constipation (OIC) in Patients With Chronic Non-cancer Pain
Study ID: NCT00414024
Conditions
Interventions
Study Description
Brief Summary: This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation in patients with non-cancer pain. Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis receive the treatment as follows: Patients will be randomly assigned to receive open label tegaserod 6 mg b.i.d. or tegaserod 12 mg o.d. using an allocation ratio of 1:1. Patients who enter this study AFTER the core study interim analysis receive the treatment as follows: Patients will be assigned to receive the selected tegaserod dose regimen (as determined by the core study interim analysis) in an open label fashion.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
60 Investigative Sites, East Hanover, New Jersey, United States
2 Investigative Sites, Hong Kong, , China
6 Investigative Sites, Egypt, , Egypt
1 Investigative Site, Singapore, , Singapore
2 Investigative Sites, Taiwan, , Taiwan
4 Investigative Sites, Venezuela, , Venezuela
Contact Details
Name: Novartis Pharmaceuticals Corp.
Affiliation: NPC
Role: PRINCIPAL_INVESTIGATOR
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