Efficacy and Safety of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain
NCT ID: NCT00365820
Last Updated: 2012-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
670 participants
INTERVENTIONAL
2006-07-31
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Tegaserod
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharma AG
Role: STUDY_CHAIR
Novartis Pharmaceuticals
Locations
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Investigative Site
Mobile, Alabama, United States
Investigative Site
Phoenix, Arizona, United States
Investigative Site
Phoenix, Arizona, United States
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Tucson, Arizona, United States
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North Little Rock, Arkansas, United States
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Buena Park, California, United States
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Downey, California, United States
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Encinitas, California, United States
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Fountain Valley, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Mission Viejo, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Torrance, California, United States
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Northglenn, Colorado, United States
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Bristol, Connecticut, United States
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DeLand, Florida, United States
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Jacksonville, Florida, United States
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Largo, Florida, United States
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Miami, Florida, United States
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New Smyrna Beach, Florida, United States
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Springhill, Florida, United States
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Tampa, Florida, United States
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Belleville, Illinois, United States
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Chicago, Illinois, United States
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Avon, Indiana, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Overland Park, Kansas, United States
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Prairie Village, Kansas, United States
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Shreveport, Louisiana, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Pahrump, Nevada, United States
Novartis Pharmaceutical Corporation
East Hanover, New Jersey, United States
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New York, New York, United States
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New York, New York, United States
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North Massapequa, New York, United States
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Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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Monroe, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Dayton, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Hershey, Pennsylvania, United States
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Levittown, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Beaumont, Texas, United States
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Colleyville, Texas, United States
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Corsicana, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Charlottesville, Virginia, United States
Investigative Site
Seattle, Washington, United States
Countries
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Other Identifiers
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CHTF919N2201
Identifier Type: -
Identifier Source: org_study_id
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