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

NCT ID: NCT00399659

Last Updated: 2012-05-01

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Opioid-induced Constipation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Tegaserod

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient has completed the 12 week double blind treatment of study CHTF919N2201

Exclusion Criteria

* Planned discontinuation of opioids during the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals Corp.

Role: STUDY_CHAIR

NPC

Locations

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Investigative Site

Mobile, Alabama, United States

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Phoenix, Arizona, United States

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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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Monroe, California, United States

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San Diego, 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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DeLande, 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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Sarasota, 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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Topeka, 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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Wellesley Hills, 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

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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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Winston-Salem, North Carolina, United States

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Oklahoma City, Oklahoma, 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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Corsicana, Texas, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, United States

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Seattle, Washington, United States

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Countries

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United States

Other Identifiers

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CHTF919N2201E1

Identifier Type: -

Identifier Source: org_study_id

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