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

This study has been terminated.
(This study was terminated early as a result of regulatory action suspending tegaserod use in 2007)
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00365820
First received: August 17, 2006
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Constipation
Drug: Tegaserod
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in the number of bowel movements over weeks 1-4

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 670
Study Start Date: July 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365820

  Hide Study Locations
Locations
United States, Alabama
Investigative Site
Mobile, Alabama, United States, 36608
United States, Arizona
Investigative Site
Phoenix, Arizona, United States, 85029
Investigative Site
Phoenix, Arizona, United States, 85050
Investigative Site
Tucson, Arizona, United States, 85712
United States, Arkansas
Investigative Site
North Little Rock, Arkansas, United States, 72117
United States, California
Investigative Site
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
United States, Colorado
Investigative Site
Northglenn, Colorado, United States, 80234
United States, Connecticut
Investigative Site
Bristol, Connecticut, United States, 06010
United States, Florida
Investigative Site
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
United States, Illinois
Investigative Site
Belleville, Illinois, United States, 62220
Investigative Site
Chicago, Illinois, United States, 60640
United States, Indiana
Investigative Site
Avon, Indiana, United States, 46123
Investigative Site
Evansville, Indiana, United States, 47714
Investigative Site
Indianapolis, Indiana, United States, 46254
United States, Kansas
Investigative Site
Overland Park, Kansas, United States, 66212
Investigative Site
Prairie Village, Kansas, United States, 66206
United States, Louisiana
Investigative Site
Shreveport, Louisiana, United States, 71103
United States, Massachusetts
Investigative Site
Boston, Massachusetts, United States, 02118
Investigative Site
Boston, Massachusetts, United States, 02215
United States, Nebraska
Investigative Site
Omaha, Nebraska, United States, 68114
Investigative Site
Omaha, Nebraska, United States, 68134
United States, Nevada
Investigative Site
Pahrump, Nevada, United States, 89048
United States, New Jersey
Novartis Pharmaceutical Corporation
East Hanover, New Jersey, United States, 07936-1080
United States, New York
Investigative Site
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
United States, North Carolina
Investigative Site
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
United States, Ohio
Investigative Site
Dayton, Ohio, United States, 45440
United States, Oklahoma
Investigative Site
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Investigative Site
Portland, Oregon, United States, 97232
United States, Pennsylvania
Investigative Site
Hershey, Pennsylvania, United States, 17033-085
Investigative Site
Levittown, Pennsylvania, United States, 19056
United States, Tennessee
Investigative Site
Chattanooga, Tennessee, United States, 37404
United States, Texas
Investigative Site
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
United States, Utah
Investigative Site
Salt Lake City, Utah, United States, 84132
United States, Virginia
Investigative Site
Charlottesville, Virginia, United States, 22903
United States, Washington
Investigative Site
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharma AG Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00365820     History of Changes
Other Study ID Numbers: CHTF919N2201
Study First Received: August 17, 2006
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Opioid, constipation, tegaserod
Opioid-induced constipation

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Analgesics, Opioid
Tegaserod
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014