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

• Status: Terminated
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3

Details

• Lead Sponsor: Novartis
• Treatments: Analgesics, Opioid; Tegaserod

Criteria

Inclusion Criteria:

1. Male and female outpatients 18 years of age or older.

2. 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.

3. Chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief.

4. 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. Patients who are receiving opioids for abdominal pain or connective tissue disorders.

2. Planned discontinuation or an increase or decrease by more than 30% of the current opioid dose

3. Patients who underwent major surgery within 3 months prior to screening.

4. 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.

5. Patients with a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators.

Other protocol-defined inclusion/exclusion criteria may apply.