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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Tegaserod

Primary Measures

• To evaluate the long term safety of tegaserod

Secondary Measures

• Change from baseline assessment of OIC symptoms at weeks 24 and 52
• Change from baseline assessment of opioid-induced mid/upper GI symptoms at weeks 24 and 52
• Patients weekly assessment of intensity of pain for which opioids were prescribed at weeks 24 and 52

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

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 Pharmaceuticals Corp. Principal Investigator NPC  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00414024

Study ID Number: CHTF919N2302

ClinicalTrials.gov Identifier: NCT00414024

Health Authority: United States: Food and Drug Administration