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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 Sep 2, 2026, 3:05 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
Oct 31, 2006
Primary completion
Mar 31, 2007
Completion
Mar 31, 2007
Last update posted
Apr 30, 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 Apr 30, 2012 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00399659 live on ClinicalTrials.gov.

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