Study Stopped
This study was terminated early as a result of regulatory action suspending tegaserod use in 2007
Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
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
1 other identifier
interventional
360
1 country
57
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2006
Shorter than P25 for phase_3
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 14, 2006
CompletedFirst Posted
Study publicly available on registry
November 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedMay 1, 2012
April 1, 2012
5 months
November 14, 2006
April 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long term safety of tegaserod
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (57)
Investigative Site
Mobile, Alabama, 36608, United States
Investigative Site
Phoenix, Arizona, 85029, United States
Investigative Site
Phoenix, Arizona, 85050, United States
Investigative Site
Tucson, Arizona, 85712, United States
Investigative Site
North Little Rock, Arkansas, 72117, United States
Investigative Site
Buena Park, California, 90620, United States
Investigative Site
Downey, California, 90240, United States
Investigative Site
Encinitas, California, 92024, United States
Investigative Site
Fountain Valley, California, 92708, United States
Investigative Site
La Jolla, California, 92037, United States
Investigative Site
Los Angeles, California, 90073, United States
Investigative Site
Mission Viejo, California, 92691, United States
Investigative Site
Monroe, California, 28112, United States
Investigative Site
San Diego, California, 92103, United States
Investigative Site
San Diego, California, 92117, United States
Investigative Site
San Francisco, California, 94115, United States
Investigative Site
Torrance, California, 90505, United States
Investigative Site
Northglenn, Colorado, 80234, United States
Investigative Site
Bristol, Connecticut, 06010, United States
Investigative Site
DeLande, Florida, 32720, United States
Investigative Site
Jacksonville, Florida, 32207, United States
Investigative Site
Largo, Florida, 33773, United States
Investigative Site
Miami, Florida, 33176, United States
Investigative Site
New Smyrna Beach, Florida, 32168, United States
Investigative Site
Sarasota, Florida, 34239, United States
Investigative Site
Springhill, Florida, 34609, United States
Investigative Site
Tampa, Florida, 33607, United States
Investigative Site
Belleville, Illinois, 62220, United States
Investigative Site
Chicago, Illinois, 60640, United States
Investigative Site
Avon, Indiana, 46123, United States
Investigative Site
Evansville, Indiana, 47714, United States
Investigative Site
Indianapolis, Indiana, 46254, United States
Investigative Site
Overland Park, Kansas, 66212, United States
Investigative Site
Prairie Village, Kansas, 66206, United States
Investigative Site
Topeka, Kansas, 66606, United States
Investigative Site
Shreveport, Louisiana, 71103, United States
Investigative Site
Boston, Massachusetts, 02118, United States
Investigative Site
Boston, Massachusetts, 02215, United States
Investigative Site
Wellesley Hills, Massachusetts, 02481-2106, United States
Investigative Site
Omaha, Nebraska, 68114, United States
Investigative Site
Omaha, Nebraska, 68134, United States
Investigative Site
Pahrump, Nevada, 89048, United States
Investigative Site
New York, New York, 10016, United States
Investigative Site
New York, New York, 10022, United States
Investigative Site
North Massapequa, New York, 11758, United States
Investigative Site
Charlotte, North Carolina, 28210, United States
Investigative Site
Greensboro, North Carolina, 27401, United States
Investigative Site
Winston-Salem, North Carolina, 27103, United States
Investigative Site
Oklahoma City, Oklahoma, 73112, United States
Investigative Site
Levittown, Pennsylvania, 19056, United States
Investigative Site
Chattanooga, Tennessee, 37404, United States
Investigative Site
Beaumont, Texas, 77701, United States
Investigative Site
Corsicana, Texas, 75110, United States
Investigative Site
Houston, Texas, 77005, United States
Investigative Site
Salt Lake City, Utah, 84132, United States
Investigative Site
Charlottesville, Virginia, 22903, United States
Investigative Site
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis Pharmaceuticals Corp.
NPC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2006
First Posted
November 15, 2006
Study Start
November 1, 2006
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
May 1, 2012
Record last verified: 2012-04