Official Title: “A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase II/III Study to Evaluate the Efficacy and Safety of Tegaserod and Placebo Given Orally for 12 Weeks for the Treatment of Opioid-Induced Constipation (OIC) in Patients With Chronic Non-Cancer Pain”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Tegaserod

Primary Measures

• Change from baseline in the number of bowel movements over weeks 1-4

Secondary Measures

• 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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharma AG Study Chair Novartis  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00365820

Study ID Number: CHTF919N2201

ClinicalTrials.gov Identifier: NCT00365820

Health Authority: United States: Food and Drug Administration