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

This study has been terminated.
(This study was terminated early as a result of regulatory action suspending tegaserod use in 2007)
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00414024
First received: December 19, 2006
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Opioid-induced Constipation
Drug: Tegaserod
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To evaluate the long term safety of tegaserod

Secondary Outcome 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

Enrollment: 11
Study Start Date: February 2007
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414024

Locations
United States, New Jersey
60 Investigative Sites
East Hanover, New Jersey, United States
China
2 Investigative Sites
Hong Kong, China
Egypt
6 Investigative Sites
Egypt, Egypt
Singapore
1 Investigative Site
Singapore, Singapore
Taiwan
2 Investigative Sites
Taiwan, Taiwan
Venezuela
4 Investigative Sites
Venezuela, Venezuela
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Pharmaceuticals Corp. NPC
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00414024     History of Changes
Other Study ID Numbers: CHTF919N2302
Study First Received: December 19, 2006
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Opioid, constipation, tegaserod

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Analgesics, Opioid
Tegaserod
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014