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

Novartis5 sites in 5 countries11 target enrollmentFebruary 2007

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2007

End Date

May 2007

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

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.
•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

•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

To evaluate the long term safety of tegaserod

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