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Terminated Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00399659

Public ClinicalTrials.gov record NCT00399659. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 11:04 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A 52-week Extension to Study CHTF919N2201 to Evaluate the Safety and Efficacy of Tegaserod (6 mg b.i.d. and 12 mg o.d.) Given Orally for the Treatment of Opioid-induced Constipation (OIC) in Patients With Chronic Non-cancer Pain

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00399659
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis
Industry
Enrollment
360 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 2006 (Type not available)
Primary completion
Apr 2007 (Actual)
Completion
Apr 2007 (Actual)
Last update posted
May 1, 2012

2006 – 2007

United States locations

U.S. sites
57
U.S. states
23
U.S. cities
52
Facility City State ZIP Site status
Investigative Site Mobile Alabama 36608 —
Investigative Site Phoenix Arizona 85029 —
Investigative Site Phoenix Arizona 85050 —
Investigative Site Tucson Arizona 85712 —
Investigative Site North Little Rock Arkansas 72117 —
Investigative Site Buena Park California 90620 —
Investigative Site Downey California 90240 —
Investigative Site Encinitas California 92024 —
Investigative Site Fountain Valley California 92708 —
Investigative Site La Jolla California 92037 —
Investigative Site Los Angeles California 90073 —
Investigative Site Mission Viejo California 92691 —
Investigative Site Monroe California 28112 —
Investigative Site San Diego California 92103 —
Investigative Site San Diego California 92117 —
Investigative Site San Francisco California 94115 —
Investigative Site Torrance California 90505 —
Investigative Site Northglenn Colorado 80234 —
Investigative Site Bristol Connecticut 06010 —
Investigative Site DeLande Florida 32720 —
Investigative Site Jacksonville Florida 32207 —
Investigative Site Largo Florida 33773 —
Investigative Site Miami Florida 33176 —
Investigative Site New Smyrna Beach Florida 32168 —
Investigative Site Sarasota Florida 34239 —
Investigative Site Springhill Florida 34609 —
Investigative Site Tampa Florida 33607 —
Investigative Site Belleville Illinois 62220 —
Investigative Site Chicago Illinois 60640 —
Investigative Site Avon Indiana 46123 —
Investigative Site Evansville Indiana 47714 —
Investigative Site Indianapolis Indiana 46254 —
Investigative Site Overland Park Kansas 66212 —
Investigative Site Prairie Village Kansas 66206 —
Investigative Site Topeka Kansas 66606 —
Investigative Site Shreveport Louisiana 71103 —
Investigative Site Boston Massachusetts 02118 —
Investigative Site Boston Massachusetts 02215 —
Investigative Site Wellesley Hills Massachusetts 02481-2106 —
Investigative Site Omaha Nebraska 68114 —
Investigative Site Omaha Nebraska 68134 —
Investigative Site Pahrump Nevada 89048 —
Investigative Site New York New York 10016 —
Investigative Site New York New York 10022 —
Investigative Site North Massapequa New York 11758 —
Investigative Site Charlotte North Carolina 28210 —
Investigative Site Greensboro North Carolina 27401 —
Investigative Site Winston-Salem North Carolina 27103 —
Investigative Site Oklahoma City Oklahoma 73112 —
Investigative Site Levittown Pennsylvania 19056 —
Investigative Site Chattanooga Tennessee 37404 —
Investigative Site Beaumont Texas 77701 —
Investigative Site Corsicana Texas 75110 —
Investigative Site Houston Texas 77005 —
Investigative Site Salt Lake City Utah 84132 —
Investigative Site Charlottesville Virginia 22903 —
Investigative Site Seattle Washington 98104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00399659, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 1, 2012 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00399659 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →