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

Novartis

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Constipation

Treatments

Drug: Tegaserod

Study type

Interventional

Funder types

Industry

Identifiers

CHTF919N2201

Details and patient eligibility

About

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

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. 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:
  1. hard or very hard stools
  2. sensation of incomplete evacuation
  3. straining while having a bowel movement

Exclusion criteria

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.