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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-05-31

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.

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Detailed Description

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Conditions

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Opioid-induced Constipation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Tegaserod

Intervention Type DRUG

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:

1. Hard or very hard stools
2. sensation of incomplete evacuation
3. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No