Efficacy and Safety 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 efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.

Official Title
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A Randomized, Double-blind, Placebo-controlled Multicenter Phase II/III Study to Evaluate the Efficacy and Safety of Tegaserod and Placebo Given Orally for 12 Weeks for the Treatment of Opioid-induced Constipation (OIC) in Patients With Chronic Non-cancer Pain

Conditions
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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. 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: hard or very hard stools sensation of incomplete evacuation straining while having a bowel movement Exclusion Criteria: Patients who are receiving opioids for abdominal pain or connective tissue disorders. Planned discontinuation or an increase or decrease by more than 30% of the current opioid dose Patients who underwent major surgery within 3 months prior to screening. Patients with a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use. Patients with a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators. 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


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 |
| --- | --- | --- |
| Change from baseline in the number of bowel movements over weeks 1-4 |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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 |  |  | 

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