Safety and Efficacy of Tegaserod in Opioid-Induced Constipation in Patients With Non-Cancer Pain. - Full Text View

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:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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

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Locations

United States, Alabama
Investigative Site
Mobile, Alabama, United States, 36608
United States, Arizona
Investigative Site
Phoenix, Arizona, United States, 85050
Investigative Site
Phoenix, Arizona, United States, 85029
Investigative Site
Tucson, Arizona, United States, 85712
United States, Arkansas
Investigative Site
North Little Rock, Arkansas, United States, 72117
United States, California
Investigative Site
Torrance, California, United States, 90505
Investigative Site
Mission Viejo, California, United States, 92691
Investigative Site
San Francisco, California, United States, 94115
Investigative Site
Buena Park, California, United States, 90620
Investigative Site
Encinitas, California, United States, 92024
Investigative Site
San Diego, California, United States, 92103
Investigative Site
La Jolla, California, United States, 92037
Investigative Site
Fountain Valley, California, United States, 92708
Investigative Site
Los Angeles, California, United States, 90073
Investigative Site
San Diego, California, United States, 92117
Investigative Site
Downey, California, United States, 90240
Investigative Site
Monroe, California, United States, 28112
United States, Colorado
Investigative Site
Northglenn, Colorado, United States, 80234
United States, Connecticut
Investigative Site
Bristol, Connecticut, United States, 06010
United States, Florida
Investigative Site
DeLande, Florida, United States, 32720
Investigative Site
Jacksonville, Florida, United States, 32207
Investigative Site
Miami, Florida, United States, 33176
Investigative Site
Largo, Florida, United States, 33773
Investigative Site
Springhill, Florida, United States, 34609
Investigative Site
New Smyrna Beach, Florida, United States, 32168
Investigative Site
Tampa, Florida, United States, 33607
Investigative Site
Sarasota, Florida, United States, 34239
United States, Illinois
Investigative Site
Chicago, Illinois, United States, 60640
Investigative Site
Belleville, Illinois, United States, 62220
United States, Indiana
Investigative Site
Evansville, Indiana, United States, 47714
Investigative Site
Indianapolis, Indiana, United States, 46254
Investigative Site
Avon, Indiana, United States, 46123
United States, Kansas
Investigative Site
Overland Park, Kansas, United States, 66212
Investigative Site
Prairie Village, Kansas, United States, 66206
Investigative Site
Topeka, Kansas, United States, 66606
United States, Louisiana
Investigative Site
Shreveport, Louisiana, United States, 71103
United States, Massachusetts
Investigative Site
Wellesley Hills, Massachusetts, United States, 02481-2106
Investigative Site
Boston, Massachusetts, United States, 02215
Investigative Site
Boston, Massachusetts, United States, 02118
United States, Nebraska
Investigative Site
Omaha, Nebraska, United States, 68114
Investigative Site
Omaha, Nebraska, United States, 68134
United States, Nevada
Investigative Site
Pahrump, Nevada, United States, 89048
United States, New York
Investigative Site
New York City, New York, United States, 10022
Investigative Site
North Massapequa, New York, United States, 11758
Investigative Site
New York, New York, United States, 10016
United States, North Carolina
Investigative Site
Winston Salem, North Carolina, United States, 27103
Investigative Site
Charlotte, North Carolina, United States, 28210
Investigative Site
Greensboro, North Carolina, United States, 27401
United States, Oklahoma
Investigative Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Investigative Site
Levittown, Pennsylvania, United States, 19056
United States, Tennessee
Investigative Site
Chattanooga, Tennessee, United States, 37404
United States, Texas
Investigative Site
Corsicana, Texas, United States, 75110
Investigative Site
Beaumont, Texas, United States, 77701
Investigative Site
Houston, Texas, United States, 77005
United States, Utah
Investigative Site
Salt Lake City, Utah, United States, 84132
United States, Virginia
Investigative Site
Charlottesville, Virginia, United States, 22903
United States, Washington
Investigative Site
Seattle, Washington, United States, 98104

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals Corp.

NPC

More Information

No publications provided

Study ID Numbers:	CHTF919N2201E1
Study First Received:	November 14, 2006
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00399659 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Opioid, constipation, tegaserod

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Physiological Effects of Drugs
Central Nervous System Depressants
Pharmacologic Actions
Signs and Symptoms
Serotonin Agents

Sensory System Agents
Therapeutic Uses
Constipation
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid
Tegaserod

ClinicalTrials.gov processed this record on November 30, 2009