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

April 19, 2012 updated by: Novartis

A Randomized, Double-blind, Placebo-controlled Multicenter Phase II/III Study to Evaluate the Efficacy and Safety of Tegaserod and Placebo Given Orally for 12 Weeks for the Treatment of Opioid-induced Constipation (OIC) in Patients With Chronic Non-cancer Pain

This study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

670

Phase

  • Phase 2
  • 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
      • San Diego, California, United States, 92103
        • 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
      • DeLand, 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
      • 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
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Investigative Site
      • Boston, Massachusetts, United States, 02215
        • 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 Jersey
      • East Hanover, New Jersey, United States, 07936-1080
        • Novartis Pharmaceutical Corporation
    • 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
      • Monroe, North Carolina, United States, 28112
        • Investigative Site
      • Winston Salem, North Carolina, United States, 27103
        • Investigative Site
    • Ohio
      • Dayton, Ohio, United States, 45440
        • Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Investigative Site
    • Oregon
      • Portland, Oregon, United States, 97232
        • Investigative Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-085
        • Investigative Site
      • Levittown, Pennsylvania, United States, 19056
        • Investigative Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Investigative Site
    • Texas
      • Beaumont, Texas, United States, 77701
        • Investigative Site
      • Colleyville, Texas, United States, 76034
        • Investigative Site
      • Corsicana, Texas, United States, 75110
        • Investigative Site
      • Houston, Texas, United States, 77005
        • Investigative Site
      • San Antonio, Texas, United States, 78229
        • 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:

  1. Male and female outpatients 18 years of age or older.
  2. Patients with chronic non-cancer pain that necessitates the use of non-injectable opioid analgesics. The equivalent dose of 300 mg morphine per day is the maximum opioid analgesic dose allowed. In general, patients should be using opioids on a daily basis.
  3. Chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief.

  4. Constipation, according to the investigator's clinical judgment, that is resulting from opioid use for non-cancer chronic pain. Opioid-induced constipation (OIC) is defined as follows:

    • less than 3 spontaneous bowel movements per week and at least one of the following on at least 25% of occasions:

      1. hard or very hard stools
      2. sensation of incomplete evacuation
      3. straining while having a bowel movement

Exclusion Criteria:

  1. Patients who are receiving opioids for abdominal pain or connective tissue disorders.
  2. Planned discontinuation or an increase or decrease by more than 30% of the current opioid dose
  3. Patients who underwent major surgery within 3 months prior to screening.
  4. Patients with a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use.
  5. Patients with a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in the number of bowel movements over weeks 1-4

Secondary Outcome Measures

Outcome Measure
Change from baseline in the number of bowel movements over weeks 1-12
Change from baseline in abdominal distension/bloating over weeks 1-12
Change from baseline in abdominal discomfort/pain over weeks 1-12

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

July 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

August 17, 2006

First Submitted That Met QC Criteria

August 17, 2006

First Posted (Estimate)

August 18, 2006

Study Record Updates

Last Update Posted (Estimate)

April 20, 2012

Last Update Submitted That Met QC Criteria

April 19, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHTF919N2201

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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