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:
NCT00399659
First received: November 14, 2006
Last updated: April 30, 2012
Last verified: April 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00399659

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00399659     History of Changes
Other Study ID Numbers: CHTF919N2201E1
Study First Received: November 14, 2006
Last Updated: April 30, 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 24, 2014