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: 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
Study ID: NCT00399659
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigative Site, Mobile, Alabama, United States
Investigative Site, Phoenix, Arizona, United States
Investigative Site, Phoenix, Arizona, United States
Investigative Site, Tucson, Arizona, United States
Investigative Site, North Little Rock, Arkansas, United States
Investigative Site, Buena Park, California, United States
Investigative Site, Downey, California, United States
Investigative Site, Encinitas, California, United States
Investigative Site, Fountain Valley, California, United States
Investigative Site, La Jolla, California, United States
Investigative Site, Los Angeles, California, United States
Investigative Site, Mission Viejo, California, United States
Investigative Site, Monroe, California, United States
Investigative Site, San Diego, California, United States
Investigative Site, San Diego, California, United States
Investigative Site, San Francisco, California, United States
Investigative Site, Torrance, California, United States
Investigative Site, Northglenn, Colorado, United States
Investigative Site, Bristol, Connecticut, United States
Investigative Site, DeLande, Florida, United States
Investigative Site, Jacksonville, Florida, United States
Investigative Site, Largo, Florida, United States
Investigative Site, Miami, Florida, United States
Investigative Site, New Smyrna Beach, Florida, United States
Investigative Site, Sarasota, Florida, United States
Investigative Site, Springhill, Florida, United States
Investigative Site, Tampa, Florida, United States
Investigative Site, Belleville, Illinois, United States
Investigative Site, Chicago, Illinois, United States
Investigative Site, Avon, Indiana, United States
Investigative Site, Evansville, Indiana, United States
Investigative Site, Indianapolis, Indiana, United States
Investigative Site, Overland Park, Kansas, United States
Investigative Site, Prairie Village, Kansas, United States
Investigative Site, Topeka, Kansas, United States
Investigative Site, Shreveport, Louisiana, United States
Investigative Site, Boston, Massachusetts, United States
Investigative Site, Boston, Massachusetts, United States
Investigative Site, Wellesley Hills, Massachusetts, United States
Investigative Site, Omaha, Nebraska, United States
Investigative Site, Omaha, Nebraska, United States
Investigative Site, Pahrump, Nevada, United States
Investigative Site, New York City, New York, United States
Investigative Site, New York, New York, United States
Investigative Site, North Massapequa, New York, United States
Investigative Site, Charlotte, North Carolina, United States
Investigative Site, Greensboro, North Carolina, United States
Investigative Site, Winston Salem, North Carolina, United States
Investigative Site, Oklahoma City, Oklahoma, United States
Investigative Site, Levittown, Pennsylvania, United States
Investigative Site, Chattanooga, Tennessee, United States
Investigative Site, Beaumont, Texas, United States
Investigative Site, Corsicana, Texas, United States
Investigative Site, Houston, Texas, United States
Investigative Site, Salt Lake City, Utah, United States
Investigative Site, Charlottesville, Virginia, United States
Investigative Site, Seattle, Washington, United States
Contact Details
Name: Novartis Pharmaceuticals Corp.
Affiliation: NPC
Role: STUDY_CHAIR
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