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 )

First Received on November 14, 2006. Last Updated on April 1, 2008 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00399659

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 III

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:

MedlinePlus related topics: Constipation

Drug Information available for: Tegaserod Tegaserod maleate

U.S. FDA Resources

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

Estimated Enrollment:	360
Study Start Date:	November 2006

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

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

ClinicalTrials.gov Identifier:	NCT00399659 History of Changes
Other Study ID Numbers:	CHTF919N2201E1
Study First Received:	November 14, 2006
Last Updated:	April 1, 2008
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 February 12, 2012