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

NCT00414024 | Terminated Phase 3

• 1 other identifier: CHTF919N2302
• Study Type: interventional
• Target: 11
• Locations: 6 countries
• Sites: 6

Brief 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.

Conditions

Opioid-induced Constipation

Keywords

Opioid, constipation, tegaserod

Outcome Measures

Primary Outcomes (1)

• To evaluate the long term safety of tegaserod

Secondary Outcomes (3)

• 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

Interventions

Tegaserod DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Hard or very hard stools
• sensation of incomplete evacuation
• straining while having a bowel movement

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (6)

60 Investigative Sites

East Hanover, New Jersey, United States

Location

2 Investigative Sites

Hong Kong, China

Location

6 Investigative Sites

Egypt, Egypt

Location

1 Investigative Site

Singapore, Singapore

Location

2 Investigative Sites

Dawan, Taiwan

Location

4 Investigative Sites

Venezuela, Venezuela

Location

MeSH Terms

Conditions

Opioid-Induced Constipation; Constipation

Interventions

tegaserod

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Novartis Pharmaceuticals Corp.

  NPC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2006
• First Posted: December 20, 2006
• Study Start: February 1, 2007
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: April 20, 2012

Record last verified: 2012-04

Locations

VE (1); TW (1); SG (1); EG (1); US (1); CN (1)