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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 in patients with non-cancer pain.
Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis receive the treatment as follows:
Patients will be randomly assigned to receive open label tegaserod 6 mg b.i.d. or tegaserod 12 mg o.d. using an allocation ratio of 1:1.
Patients who enter this study AFTER the core study interim analysis receive the treatment as follows:
Patients will be assigned to receive the selected tegaserod dose regimen (as determined by the core study interim analysis) in an open label fashion.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegaserod | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the long term safety of tegaserod |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline assessment of OIC symptoms at weeks 24 and 52 | ||
| Change from baseline assessment of opioid-induced mid/upper GI symptoms at weeks 24 and 52 | ||
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Inclusion Criteria:
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 Pharmaceuticals Corp. | NPC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 60 Investigative Sites | East Hanover | New Jersey | United States | |||
| 2 Investigative Sites |
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| 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 |
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| ID | Term |
|---|---|
| C105050 | tegaserod |
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| Patients weekly assessment of intensity of pain for which opioids were prescribed at weeks 24 and 52 |
| Hong Kong |
| China |
| 6 Investigative Sites | Egypt | Egypt |
| 1 Investigative Site | Singapore | Singapore |
| 2 Investigative Sites | Dawan | Taiwan |
| 4 Investigative Sites | Venezuela | Venezuela |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |