Overview

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

Status:
Terminated
Trial end date:
2007-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Details
Lead Sponsor:
Novartis
Treatments:
Analgesics, Opioid
Tegaserod
Criteria
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.

Other protocol-defined inclusion/exclusion criteria may apply