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

Primary Purpose

Constipation

Status
Terminated
Phase
Phase 2
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 Constipation focused on measuring Opioid, constipation, tegaserod, Opioid-induced constipation

Eligibility Criteria

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

Inclusion Criteria: Male and female outpatients 18 years of age or older. Patients with chronic non-cancer pain that necessitates the use of non-injectable opioid analgesics. The equivalent dose of 300 mg morphine per day is the maximum opioid analgesic dose allowed. In general, patients should be using opioids on a daily basis. Chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief. Constipation, according to the investigator's clinical judgment, that is resulting from opioid use for non-cancer chronic pain. Opioid-induced constipation (OIC) is defined as follows: less than 3 spontaneous bowel movements per week and at least one of the following on at least 25% of occasions: hard or very hard stools sensation of incomplete evacuation straining while having a bowel movement Exclusion Criteria: Patients who are receiving opioids for abdominal pain or connective tissue disorders. Planned discontinuation or an increase or decrease by more than 30% of the current opioid dose Patients who underwent major surgery within 3 months prior to screening. Patients with a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use. Patients with a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators. Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

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  • Novartis Pharmaceutical Corporation
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Outcomes

Primary Outcome Measures

Change from baseline in the number of bowel movements over weeks 1-4

Secondary Outcome Measures

Change from baseline in the number of bowel movements over weeks 1-12
Change from baseline in abdominal distension/bloating over weeks 1-12
Change from baseline in abdominal discomfort/pain over weeks 1-12

Full Information

First Posted
August 17, 2006
Last Updated
April 19, 2012
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00365820
Brief Title
Efficacy and Safety of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain
Official Title
A Randomized, Double-blind, Placebo-controlled Multicenter Phase II/III Study to Evaluate the Efficacy and Safety of Tegaserod and Placebo Given Orally for 12 Weeks 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
July 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 efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
670 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tegaserod
Primary Outcome Measure Information:
Title
Change from baseline in the number of bowel movements over weeks 1-4
Secondary Outcome Measure Information:
Title
Change from baseline in the number of bowel movements over weeks 1-12
Title
Change from baseline in abdominal distension/bloating over weeks 1-12
Title
Change from baseline in abdominal discomfort/pain over weeks 1-12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: Male and female outpatients 18 years of age or older. Patients with chronic non-cancer pain that necessitates the use of non-injectable opioid analgesics. The equivalent dose of 300 mg morphine per day is the maximum opioid analgesic dose allowed. In general, patients should be using opioids on a daily basis. Chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief. Constipation, according to the investigator's clinical judgment, that is resulting from opioid use for non-cancer chronic pain. Opioid-induced constipation (OIC) is defined as follows: less than 3 spontaneous bowel movements per week and at least one of the following on at least 25% of occasions: hard or very hard stools sensation of incomplete evacuation straining while having a bowel movement Exclusion Criteria: Patients who are receiving opioids for abdominal pain or connective tissue disorders. Planned discontinuation or an increase or decrease by more than 30% of the current opioid dose Patients who underwent major surgery within 3 months prior to screening. Patients with a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use. Patients with a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators. Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharma AG
Organizational Affiliation
Novartis Pharmaceuticals
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
San Diego
State/Province
California
ZIP/Postal Code
92103
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
Country
United States
Facility Name
Investigative Site
City
Northglenn
State/Province
Colorado
ZIP/Postal Code
80234
Country
United States
Facility Name
Investigative Site
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Investigative Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Investigative Site
City
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
Facility Name
Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Investigative Site
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
Investigative Site
City
Springhill
State/Province
Florida
ZIP/Postal Code
34609
Country
United States
Facility Name
Investigative Site
City
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
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Investigative Site
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Investigative Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
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
Novartis Pharmaceutical Corporation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936-1080
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
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
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
Dayton
State/Province
Ohio
ZIP/Postal Code
45440
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
Portland
State/Province
Oregon
ZIP/Postal Code
97232
Country
United States
Facility Name
Investigative Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-085
Country
United States
Facility Name
Investigative Site
City
Levittown
State/Province
Pennsylvania
ZIP/Postal Code
19056
Country
United States
Facility Name
Investigative Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Investigative Site
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Investigative Site
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
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
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
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

Learn more about this trial

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

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