Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.

Stopped early · Phase 3

Conditions studied: Opioid-induced Constipation

In brief

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.

Key facts

Study ID

NCT00399659

Run by

Novartis

People needed

360

Starts

2006-11-01

Expected to finish

2007-04-01

Last updated by the study team

2012-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has completed the 12 week double blind treatment of study CHTF919N2201

You may not qualify if…

• Planned discontinuation of opioids during the study.
• Development of any of the medical conditions listed as exclusion criteria for the CHTF919N2201 study.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• 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 — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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