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

Novartis

Status and phase: Terminated; Phase 3

Conditions: Opioid-induced Constipation

Treatments: Drug: Tegaserod

Study type: Interventional

Funder types: Industry

Identifiers

NCT00414024

CHTF919N2302

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)