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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Opioid-induced Constipation

Intervention: Tegaserod (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals Corp., Study Chair, Affiliation: NPC

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.

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Long term safety of tegaserod

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

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 City, New York 10022, United States

Investigative Site, New York, New York 10016, 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

Additional Information

Starting date: November 2006
Last updated: April 30, 2012

Page last updated: August 23, 2015

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