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

Novartis2 sites in 1 country670 target enrollmentJuly 2006

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Constipation
Sponsor: Novartis
Enrollment: 670
Locations: 2
Primary Endpoint: Change from baseline in the number of bowel movements over weeks 1-4
Status: Terminated
Last Updated: 14 years ago

This study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.

Registry

clinicaltrials.gov

Start Date

July 2006

End Date

April 2007

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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.