Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label 52-week Study to Evaluate the Safety and Efficacy of Tegaserod Given Orally for the Treatment of Opioid-induced Constipation (OIC) in Patients With Chronic Non-cancer Pain

Conditions
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Opioid-induced Constipation

Intervention / Treatment
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* Drug: Tegaserod


Participation Criteria
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Eligibility Criteria
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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. 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: Hard or very hard stools sensation of incomplete evacuation straining while having a bowel movement Exclusion Criteria: 1. Who are receiving opioids for abdominal pain or connective tissue disorders. Planned discontinuation of opioids during the study Who underwent major surgery within 3 months prior to screening. With a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use. With a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators. With a previous use of tegaserod within 3 months prior to baseline. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tegaserod|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the long term safety of tegaserod |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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 |  |  | 
| Patients weekly assessment of intensity of pain for which opioids were prescribed at weeks 24 and 52 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid, constipation, tegaserod