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

Stopped early · Phase 3

Conditions studied: Opioid-induced Constipation

In brief

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.

Key facts

Study ID

NCT00414024

Run by

Novartis

People needed

11

Starts

2007-02-01

Expected to finish

2007-05-01

Last updated by the study team

2012-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 60 Investigative Sites — East Hanover, New Jersey, United States
• 2 Investigative Sites — Hong Kong, China
• 6 Investigative Sites — Egypt, Egypt
• 1 Investigative Site — Singapore, Singapore
• 2 Investigative Sites — Dawan, Taiwan
• 4 Investigative Sites — Venezuela, Venezuela

Full record on ClinicalTrials.gov

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