Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
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.
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
- Enrollment
- 360 participants
Conditions and interventions
Conditions
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.