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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 efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegaserod | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the number of bowel movements over weeks 1-4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the number of bowel movements over weeks 1-12 | ||
| Change from baseline in abdominal distension/bloating over weeks 1-12 | ||
| Change from baseline in abdominal discomfort/pain over weeks 1-12 |
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Inclusion Criteria:
Male and female outpatients 18 years of age or older.
Patients with chronic non-cancer pain that necessitates the use of non-injectable opioid analgesics. The equivalent dose of 300 mg morphine per day is the maximum opioid analgesic dose allowed. In general, patients should be using opioids on a daily basis.
Chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief.
Constipation, according to the investigator's clinical judgment, that is resulting from opioid use for non-cancer chronic pain. Opioid-induced constipation (OIC) is defined as follows:
less than 3 spontaneous bowel movements per week and at least one of the following on at least 25% of occasions:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharma AG | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Mobile | Alabama | 36608 | United States | ||
| Investigative Site |
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| 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 | San Diego | California | 92103 | 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 | DeLand | 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 | 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 | Shreveport | Louisiana | 71103 | United States |
| Investigative Site | Boston | Massachusetts | 02118 | United States |
| Investigative Site | Boston | Massachusetts | 02215 | United States |
| Investigative Site | Omaha | Nebraska | 68114 | United States |
| Investigative Site | Omaha | Nebraska | 68134 | United States |
| Investigative Site | Pahrump | Nevada | 89048 | United States |
| Novartis Pharmaceutical Corporation | East Hanover | New Jersey | 07936-1080 | 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 | Monroe | North Carolina | 28112 | United States |
| Investigative Site | Winston-Salem | North Carolina | 27103 | United States |
| Investigative Site | Dayton | Ohio | 45440 | United States |
| Investigative Site | Oklahoma City | Oklahoma | 73112 | United States |
| Investigative Site | Portland | Oregon | 97232 | United States |
| Investigative Site | Hershey | Pennsylvania | 17033-085 | 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 | Colleyville | Texas | 76034 | United States |
| Investigative Site | Corsicana | Texas | 75110 | United States |
| Investigative Site | Houston | Texas | 77005 | United States |
| Investigative Site | San Antonio | Texas | 78229 | 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 |
|---|---|
| D003248 | Constipation |
| D000079689 | Opioid-Induced 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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