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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

International

Study Type

Interventional

Intervention

Tegaserod

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:

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.
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:

1. Who are receiving opioids for abdominal pain or connective tissue disorders.
Planned discontinuation of opioids during the study
Who underwent major surgery within 3 months prior to screening.
With a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use.
With a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators.
With a previous use of tegaserod within 3 months prior to baseline.

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

60 Investigative Sites
2 Investigative Sites
6 Investigative Sites
1 Investigative Site
2 Investigative Sites
4 Investigative Sites

Outcomes

Primary Outcome Measures

To evaluate the long term safety of tegaserod

Secondary Outcome Measures

Change from baseline assessment of OIC symptoms at weeks 24 and 52

Change from baseline assessment of opioid-induced mid/upper GI symptoms at weeks 24 and 52

Patients weekly assessment of intensity of pain for which opioids were prescribed at weeks 24 and 52

Full Information

NCT ID

NCT00414024

First Posted

December 19, 2006

Last Updated

April 19, 2012

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00414024

Brief Title

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

Official Title

An Open Label 52-week Study to Evaluate the Safety and Efficacy of Tegaserod 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

February 2007 (undefined)

Primary Completion Date

May 2007 (Actual)

Study Completion Date

May 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 in patients with non-cancer pain. Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis receive the treatment as follows: Patients will be randomly assigned to receive open label tegaserod 6 mg b.i.d. or tegaserod 12 mg o.d. using an allocation ratio of 1:1. Patients who enter this study AFTER the core study interim analysis receive the treatment as follows: Patients will be assigned to receive the selected tegaserod dose regimen (as determined by the core study interim analysis) in an open label fashion.

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

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Tegaserod

Primary Outcome Measure Information:

Title

To evaluate the long term safety of tegaserod

Secondary Outcome Measure Information:

Title

Change from baseline assessment of OIC symptoms at weeks 24 and 52

Title

Change from baseline assessment of opioid-induced mid/upper GI symptoms at weeks 24 and 52

Title

Patients weekly assessment of intensity of pain for which opioids were prescribed at weeks 24 and 52

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. 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: 1. Who are receiving opioids for abdominal pain or connective tissue disorders. Planned discontinuation of opioids during the study Who underwent major surgery within 3 months prior to screening. With a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use. With a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators. With a previous use of tegaserod within 3 months prior to baseline. 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

Principal Investigator

Facility Information:

Facility Name

60 Investigative Sites

City

East Hanover

State/Province

New Jersey

Country

United States

Facility Name

2 Investigative Sites

City

Hong Kong

Country

China

Facility Name

6 Investigative Sites

City

Egypt

Country

Egypt

Facility Name

1 Investigative Site

City

Singapore

Country

Singapore

Facility Name

2 Investigative Sites

City

Taiwan

Country

Taiwan

Facility Name

4 Investigative Sites

City

Venezuela

Country

Venezuela

12. IPD Sharing Statement

Learn more about this trial

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

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