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...
Date First Received: November 14, 2006
Last Updated: April 1, 2008
Verified by: Novartis, April 2008
Clinical Trial Phase: Phase 3 | Start Date: November 2006
Overall Status: Terminated
Estimated Enrollment: 360
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Tegaserod
Outcome Measures for this Clinical Trial
Primary Measures
- Long term safety of tegaserod
Secondary Measures
- Change from baseline assessment of OIC symptoms, at week 24 and 52
- Change from baseline assessment of opioid-induced mid/upper GI symptoms, at week 24 and 52
- Patients' weekly assessment of intensity of pain for which opioids were prescribed, at week 24 and 52
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patient has completed the 12 week double blind treatment of study CHTF919N2201
Exclusion Criteria:
- 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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Corp. Study Chair NPC
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00399659
Study ID Number: CHTF919N2201E1
ClinicalTrials.gov Identifier: NCT00399659
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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