Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Outcome Measures
Primary Outcome Measures
- To evaluate the long term safety of tegaserod []
Secondary Outcome Measures
- 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 []
- Patients weekly assessment of intensity of pain for which opioids were prescribed at weeks 24 and 52 []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and female outpatients 18 years of age or older.
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Patients with chronic non-cancer pain that necessitates the use of non- injectable opioid analgesics.
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Chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief.
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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:
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Hard or very hard stools
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sensation of incomplete evacuation
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straining while having a bowel movement
Exclusion Criteria:
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- Who are receiving opioids for abdominal pain or connective tissue disorders.
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Planned discontinuation of opioids during the study
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Who underwent major surgery within 3 months prior to screening.
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With a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use.
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With a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators.
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With a previous use of tegaserod within 3 months prior to baseline.
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 60 Investigative Sites | East Hanover | New Jersey | United States | |
| 2 | 2 Investigative Sites | Hong Kong | China | ||
| 3 | 6 Investigative Sites | Egypt | Egypt | ||
| 4 | 1 Investigative Site | Singapore | Singapore | ||
| 5 | 2 Investigative Sites | Taiwan | Taiwan | ||
| 6 | 4 Investigative Sites | Venezuela | Venezuela |
Sponsors and Collaborators
- Novartis
Investigators
- Principal Investigator: Novartis Pharmaceuticals Corp., NPC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHTF919N2302