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

Opioid-induced Constipation Clinical Trial

Official title:

An Open Label 52-week Study to Evaluate the Safety and Efficacy of Tegaserod Given Orally for the Treatment of Opioid-induced Constipation (OIC) in Patients With Chronic Non-cancer Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00414024
• Other study ID #: CHTF919N2302
• Status: Terminated
• Phase: Phase 3
• First received: December 19, 2006
• Last updated: April 19, 2012
• Start date: February 2007
• Est. completion date: May 2007

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Opioid-induced Constipation

Intervention

Drug:
• Tegaserod

Locations

Country	Name	City	State
China	2 Investigative Sites	Hong Kong
Egypt	6 Investigative Sites	Egypt
Singapore	1 Investigative Site	Singapore
Taiwan	2 Investigative Sites	Taiwan
United States	60 Investigative Sites	East Hanover	New Jersey
Venezuela	4 Investigative Sites	Venezuela

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Venezuela,  China,  Egypt,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the long term safety of tegaserod
Secondary	Change from baseline assessment of OIC symptoms at weeks 24 and 52
Secondary	Change from baseline assessment of opioid-induced mid/upper GI symptoms at weeks 24 and 52
Secondary	Patients weekly assessment of intensity of pain for which opioids were prescribed at weeks 24 and 52