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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Opioid-induced Constipation

Intervention: Tegaserod (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals Corp., Principal Investigator, Affiliation: NPC

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.

Clinical Details

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

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

Primary outcome: To evaluate the long term safety of tegaserod

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

2 Investigative Sites, Hong Kong, China

6 Investigative Sites, Egypt, Egypt

1 Investigative Site, Singapore, Singapore

2 Investigative Sites, Taiwan, Taiwan

4 Investigative Sites, Venezuela, Venezuela

60 Investigative Sites, East Hanover, New Jersey, United States

Additional Information

Starting date: February 2007
Last updated: April 19, 2012

Page last updated: August 23, 2015

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