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

April 30, 2012 updated by: Novartis

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Investigative Site
    • Arizona
      • Phoenix, Arizona, United States, 85029
        • Investigative Site
      • Phoenix, Arizona, United States, 85050
        • Investigative Site
      • Tucson, Arizona, United States, 85712
        • Investigative Site
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Investigative Site
    • California
      • Buena Park, California, United States, 90620
        • Investigative Site
      • Downey, California, United States, 90240
        • Investigative Site
      • Encinitas, California, United States, 92024
        • Investigative Site
      • Fountain Valley, California, United States, 92708
        • Investigative Site
      • La Jolla, California, United States, 92037
        • Investigative Site
      • Los Angeles, California, United States, 90073
        • Investigative Site
      • Mission Viejo, California, United States, 92691
        • Investigative Site
      • Monroe, California, United States, 28112
        • Investigative Site
      • San Diego, California, United States, 92103
        • Investigative Site
      • San Diego, California, United States, 92117
        • Investigative Site
      • San Francisco, California, United States, 94115
        • Investigative Site
      • Torrance, California, United States, 90505
        • Investigative Site
    • Colorado
      • Northglenn, Colorado, United States, 80234
        • Investigative Site
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Investigative Site
    • Florida
      • DeLande, Florida, United States, 32720
        • Investigative Site
      • Jacksonville, Florida, United States, 32207
        • Investigative Site
      • Largo, Florida, United States, 33773
        • Investigative Site
      • Miami, Florida, United States, 33176
        • Investigative Site
      • New Smyrna Beach, Florida, United States, 32168
        • Investigative Site
      • Sarasota, Florida, United States, 34239
        • Investigative Site
      • Springhill, Florida, United States, 34609
        • Investigative Site
      • Tampa, Florida, United States, 33607
        • Investigative Site
    • Illinois
      • Belleville, Illinois, United States, 62220
        • Investigative Site
      • Chicago, Illinois, United States, 60640
        • Investigative Site
    • Indiana
      • Avon, Indiana, United States, 46123
        • Investigative Site
      • Evansville, Indiana, United States, 47714
        • Investigative Site
      • Indianapolis, Indiana, United States, 46254
        • Investigative Site
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Investigative Site
      • Prairie Village, Kansas, United States, 66206
        • Investigative Site
      • Topeka, Kansas, United States, 66606
        • Investigative Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Investigative Site
      • Boston, Massachusetts, United States, 02215
        • Investigative Site
      • Wellesley Hills, Massachusetts, United States, 02481-2106
        • Investigative Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Investigative Site
      • Omaha, Nebraska, United States, 68134
        • Investigative Site
    • Nevada
      • Pahrump, Nevada, United States, 89048
        • Investigative Site
    • New York
      • New York, New York, United States, 10016
        • Investigative Site
      • New York City, New York, United States, 10022
        • Investigative Site
      • North Massapequa, New York, United States, 11758
        • Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Investigative Site
      • Greensboro, North Carolina, United States, 27401
        • Investigative Site
      • Winston Salem, North Carolina, United States, 27103
        • Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Investigative Site
    • Pennsylvania
      • Levittown, Pennsylvania, United States, 19056
        • Investigative Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Investigative Site
    • Texas
      • Beaumont, Texas, United States, 77701
        • Investigative Site
      • Corsicana, Texas, United States, 75110
        • Investigative Site
      • Houston, Texas, United States, 77005
        • Investigative Site
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Investigative Site
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Investigative Site
    • Washington
      • Seattle, Washington, United States, 98104
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Long term safety of tegaserod

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

November 14, 2006

First Submitted That Met QC Criteria

November 14, 2006

First Posted (Estimate)

November 15, 2006

Study Record Updates

Last Update Posted (Estimate)

May 1, 2012

Last Update Submitted That Met QC Criteria

April 30, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHTF919N2201E1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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