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

Phase 2

Terminated

• Conditions: Constipation

• Registration Number: NCT00365820
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-08-17
• Study First Submitted QC: 2006-08-17
• Study First Posted: 2006-08-18
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-19
• Last Update Posted: 2012-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 670

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in the number of bowel movements over weeks 1-4

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the number of bowel movements over weeks 1-12
Change from baseline in abdominal distension/bloating over weeks 1-12
Change from baseline in abdominal discomfort/pain over weeks 1-12

Trial Locations

Locations (2)

Novartis Pharmaceutical Corporation; 🇺🇸 East Hanover, New Jersey, United States

Investigative Site; 🇺🇸 Seattle, Washington, United States