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

Primary Purpose

Opioid-induced Constipation

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tegaserod
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-induced Constipation focused on measuring Opioid, constipation, tegaserod

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

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Outcomes

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

Full Information

First Posted
November 14, 2006
Last Updated
April 30, 2012
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00399659
Brief Title
Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated early as a result of regulatory action suspending tegaserod use in 2007
Study Start Date
November 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-induced Constipation
Keywords
Opioid, constipation, tegaserod

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tegaserod
Primary Outcome Measure Information:
Title
Long term safety of tegaserod
Secondary Outcome Measure Information:
Title
Change from baseline assessment of OIC symptoms, at week 24 and 52
Title
Change from baseline assessment of opioid-induced mid/upper GI symptoms, at week 24 and 52
Title
Patients' weekly assessment of intensity of pain for which opioids were prescribed, at week 24 and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals Corp.
Organizational Affiliation
NPC
Official's Role
Study Chair
Facility Information:
Facility Name
Investigative Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85029
Country
United States
Facility Name
Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Investigative Site
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Investigative Site
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Investigative Site
City
Downey
State/Province
California
ZIP/Postal Code
90240
Country
United States
Facility Name
Investigative Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Investigative Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Investigative Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Investigative Site
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Investigative Site
City
Monroe
State/Province
California
ZIP/Postal Code
28112
Country
United States
Facility Name
Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Investigative Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Investigative Site
City
Torrance
State/Province
California
ZIP/Postal Code
90505
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United States
Facility Name
Investigative Site
City
Northglenn
State/Province
Colorado
ZIP/Postal Code
80234
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United States
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Investigative Site
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Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
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United States
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Investigative Site
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DeLande
State/Province
Florida
ZIP/Postal Code
32720
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United States
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Investigative Site
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Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Investigative Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
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Investigative Site
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Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Investigative Site
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New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
Investigative Site
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Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Investigative Site
City
Springhill
State/Province
Florida
ZIP/Postal Code
34609
Country
United States
Facility Name
Investigative Site
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Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Investigative Site
City
Belleville
State/Province
Illinois
ZIP/Postal Code
62220
Country
United States
Facility Name
Investigative Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Investigative Site
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Investigative Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Investigative Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
Investigative Site
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Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
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United States
Facility Name
Investigative Site
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Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
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United States
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Investigative Site
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Topeka
State/Province
Kansas
ZIP/Postal Code
66606
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United States
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Investigative Site
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Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
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United States
Facility Name
Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
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United States
Facility Name
Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
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United States
Facility Name
Investigative Site
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Wellesley Hills
State/Province
Massachusetts
ZIP/Postal Code
02481-2106
Country
United States
Facility Name
Investigative Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Investigative Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Investigative Site
City
Pahrump
State/Province
Nevada
ZIP/Postal Code
89048
Country
United States
Facility Name
Investigative Site
City
New York City
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Investigative Site
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Facility Name
Investigative Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Investigative Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Investigative Site
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Investigative Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Investigative Site
City
Levittown
State/Province
Pennsylvania
ZIP/Postal Code
19056
Country
United States
Facility Name
Investigative Site
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Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Investigative Site
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
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United States
Facility Name
Investigative Site
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
Facility Name
Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
Investigative Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Investigative Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

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

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