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This study was terminated early as a result of regulatory action suspending tegaserod use in 2007
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegaserod | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Long term safety of tegaserod |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline assessment of OIC symptoms, at week 24 and 52 | ||
| Change from baseline assessment of opioid-induced mid/upper GI symptoms, at week 24 and 52 | ||
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals Corp. | NPC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Mobile | Alabama | 36608 | United States | ||
| Investigative Site |
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| Patients' weekly assessment of intensity of pain for which opioids were prescribed, at week 24 and 52 |
| Phoenix |
| Arizona |
| 85029 |
| United States |
| Investigative Site | Phoenix | Arizona | 85050 | United States |
| Investigative Site | Tucson | Arizona | 85712 | United States |
| Investigative Site | North Little Rock | Arkansas | 72117 | United States |
| Investigative Site | Buena Park | California | 90620 | United States |
| Investigative Site | Downey | California | 90240 | United States |
| Investigative Site | Encinitas | California | 92024 | United States |
| Investigative Site | Fountain Valley | California | 92708 | United States |
| Investigative Site | La Jolla | California | 92037 | United States |
| Investigative Site | Los Angeles | California | 90073 | United States |
| Investigative Site | Mission Viejo | California | 92691 | United States |
| Investigative Site | Monroe | California | 28112 | United States |
| Investigative Site | San Diego | California | 92103 | United States |
| Investigative Site | San Diego | California | 92117 | United States |
| Investigative Site | San Francisco | California | 94115 | United States |
| Investigative Site | Torrance | California | 90505 | United States |
| Investigative Site | Northglenn | Colorado | 80234 | United States |
| Investigative Site | Bristol | Connecticut | 06010 | United States |
| Investigative Site | DeLande | Florida | 32720 | United States |
| Investigative Site | Jacksonville | Florida | 32207 | United States |
| Investigative Site | Largo | Florida | 33773 | United States |
| Investigative Site | Miami | Florida | 33176 | United States |
| Investigative Site | New Smyrna Beach | Florida | 32168 | United States |
| Investigative Site | Sarasota | Florida | 34239 | United States |
| Investigative Site | Springhill | Florida | 34609 | United States |
| Investigative Site | Tampa | Florida | 33607 | United States |
| Investigative Site | Belleville | Illinois | 62220 | United States |
| Investigative Site | Chicago | Illinois | 60640 | United States |
| Investigative Site | Avon | Indiana | 46123 | United States |
| Investigative Site | Evansville | Indiana | 47714 | United States |
| Investigative Site | Indianapolis | Indiana | 46254 | United States |
| Investigative Site | Overland Park | Kansas | 66212 | United States |
| Investigative Site | Prairie Village | Kansas | 66206 | United States |
| Investigative Site | Topeka | Kansas | 66606 | United States |
| Investigative Site | Shreveport | Louisiana | 71103 | United States |
| Investigative Site | Boston | Massachusetts | 02118 | United States |
| Investigative Site | Boston | Massachusetts | 02215 | United States |
| Investigative Site | Wellesley Hills | Massachusetts | 02481-2106 | United States |
| Investigative Site | Omaha | Nebraska | 68114 | United States |
| Investigative Site | Omaha | Nebraska | 68134 | United States |
| Investigative Site | Pahrump | Nevada | 89048 | United States |
| Investigative Site | New York | New York | 10016 | United States |
| Investigative Site | New York | New York | 10022 | United States |
| Investigative Site | North Massapequa | New York | 11758 | United States |
| Investigative Site | Charlotte | North Carolina | 28210 | United States |
| Investigative Site | Greensboro | North Carolina | 27401 | United States |
| Investigative Site | Winston-Salem | North Carolina | 27103 | United States |
| Investigative Site | Oklahoma City | Oklahoma | 73112 | United States |
| Investigative Site | Levittown | Pennsylvania | 19056 | United States |
| Investigative Site | Chattanooga | Tennessee | 37404 | United States |
| Investigative Site | Beaumont | Texas | 77701 | United States |
| Investigative Site | Corsicana | Texas | 75110 | United States |
| Investigative Site | Houston | Texas | 77005 | United States |
| Investigative Site | Salt Lake City | Utah | 84132 | United States |
| Investigative Site | Charlottesville | Virginia | 22903 | United States |
| Investigative Site | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D000079689 | Opioid-Induced Constipation |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C105050 | tegaserod |
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