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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:
ClinicalTrials.gov Identifier:
NCT00399659
First Posted: November 15, 2006
Last Update Posted: May 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  Purpose

This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation (OIC) in patients with non-cancer pain.

Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis (IA) receive the treatment as follows:

Patients on tegaserod 6 mg twice daily (b.i.d.) or 12 mg once daily (o.d.) in the core study will remain on the same dose in the extension (double-blind).

Patients on placebo during the core study will receive tegaserod 12 mg o.d. (open-label)

Patients who enter this study AFTER the core study interim analysis will receive the selected tegaserod dose regimen (open-label) determined by the core study IA.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 52-week Extension to Study CHTF919N2201 to Evaluate the Safety and Efficacy of Tegaserod (6 mg b.i.d. and 12 mg o.d.) 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:
  • Long term safety of tegaserod

Secondary Outcome Measures:
  • Change from baseline assessment of OIC symptoms, at week 24 and 52
  • Change from baseline assessment of opioid-induced mid/upper GI symptoms, at week 24 and 52
  • Patients' weekly assessment of intensity of pain for which opioids were prescribed, at week 24 and 52

Enrollment: 360
Study Start Date: November 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Patient has completed the 12 week double blind treatment of study CHTF919N2201

Exclusion Criteria:

  • Planned discontinuation of opioids during the study.
  • Development of any of the medical conditions listed as exclusion criteria for the CHTF919N2201 study.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399659


  Show 57 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Corp. NPC
  More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00399659     History of Changes
Other Study ID Numbers: CHTF919N2201E1
First Submitted: November 14, 2006
First Posted: November 15, 2006
Last Update Posted: May 1, 2012
Last Verified: April 2012

Keywords provided by Novartis:
Opioid, constipation, tegaserod

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