Study Stopped
This study was terminated early as a result of regulatory action suspending tegaserod use in 2007
Efficacy and Safety of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain
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
1 other identifier
interventional
670
1 country
59
Brief Summary
This study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2006
Shorter than P25 for phase_2
59 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
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 17, 2006
CompletedFirst Posted
Study publicly available on registry
August 18, 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
CompletedApril 20, 2012
April 1, 2012
9 months
August 17, 2006
April 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the number of bowel movements over weeks 1-4
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- Male and female outpatients 18 years of age or older.
- 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.
- Chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief.
- 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:
- hard or very hard stools
- sensation of incomplete evacuation
- straining while having a bowel movement
You may not qualify if:
- Patients who are receiving opioids for abdominal pain or connective tissue disorders.
- Planned discontinuation or an increase or decrease by more than 30% of the current opioid dose
- Patients who underwent major surgery within 3 months prior to screening.
- 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.
- Patients with a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (59)
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
San Diego, California, 92103, 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
DeLand, 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
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
Shreveport, Louisiana, 71103, United States
Investigative Site
Boston, Massachusetts, 02118, United States
Investigative Site
Boston, Massachusetts, 02215, United States
Investigative Site
Omaha, Nebraska, 68114, United States
Investigative Site
Omaha, Nebraska, 68134, United States
Investigative Site
Pahrump, Nevada, 89048, United States
Novartis Pharmaceutical Corporation
East Hanover, New Jersey, 07936-1080, 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
Monroe, North Carolina, 28112, United States
Investigative Site
Winston-Salem, North Carolina, 27103, United States
Investigative Site
Dayton, Ohio, 45440, United States
Investigative Site
Oklahoma City, Oklahoma, 73112, United States
Investigative Site
Portland, Oregon, 97232, United States
Investigative Site
Hershey, Pennsylvania, 17033-085, 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
Colleyville, Texas, 76034, United States
Investigative Site
Corsicana, Texas, 75110, United States
Investigative Site
Houston, Texas, 77005, United States
Investigative Site
San Antonio, Texas, 78229, 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 Pharma AG
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2006
First Posted
August 18, 2006
Study Start
July 1, 2006
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
April 20, 2012
Record last verified: 2012-04