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

Constipation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00365820
• Other study ID #: CHTF919N2201
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: August 17, 2006
• Last updated: April 19, 2012
• Start date: July 2006
• Est. completion date: April 2007

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 670
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male and female outpatients 18 years of age or older.

2. 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.

3. Chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief.

4. 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:

1. hard or very hard stools

2. sensation of incomplete evacuation

3. straining while having a bowel movement

Exclusion Criteria:

1. Patients who are receiving opioids for abdominal pain or connective tissue disorders.

2. Planned discontinuation or an increase or decrease by more than 30% of the current opioid dose

3. Patients who underwent major surgery within 3 months prior to screening.

4. 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.

5. Patients with a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• Tegaserod

Locations

Country	Name	City	State
United States	Investigative Site	Avon	Indiana
United States	Investigative Site	Beaumont	Texas
United States	Investigative Site	Belleville	Illinois
United States	Investigative Site	Boston	Massachusetts
United States	Investigative Site	Boston	Massachusetts
United States	Investigative Site	Bristol	Connecticut
United States	Investigative Site	Buena Park	California
United States	Investigative Site	Charlotte	North Carolina
United States	Investigative Site	Charlottesville	Virginia
United States	Investigative Site	Chattanooga	Tennessee
United States	Investigative Site	Chicago	Illinois
United States	Investigative Site	Colleyville	Texas
United States	Investigative Site	Corsicana	Texas
United States	Investigative Site	Dayton	Ohio
United States	Investigative Site	DeLand	Florida
United States	Investigative Site	Downey	California
United States	Novartis Pharmaceutical Corporation	East Hanover	New Jersey
United States	Investigative Site	Encinitas	California
United States	Investigative Site	Evansville	Indiana
United States	Investigative Site	Fountain Valley	California
United States	Investigative Site	Greensboro	North Carolina
United States	Investigative Site	Hershey	Pennsylvania
United States	Investigative Site	Houston	Texas
United States	Investigative Site	Indianapolis	Indiana
United States	Investigative Site	Jacksonville	Florida
United States	Investigative Site	La Jolla	California
United States	Investigative Site	Largo	Florida
United States	Investigative Site	Levittown	Pennsylvania
United States	Investigative Site	Los Angeles	California
United States	Investigative Site	Miami	Florida
United States	Investigative Site	Mission Viejo	California
United States	Investigative Site	Mobile	Alabama
United States	Investigative Site	Monroe	North Carolina
United States	Investigative Site	New Smyrna Beach	Florida
United States	Investigative Site	New York	New York
United States	Investigative Site	New York City	New York
United States	Investigative Site	North Little Rock	Arkansas
United States	Investigative Site	North Massapequa	New York
United States	Investigative Site	Northglenn	Colorado
United States	Investigative Site	Oklahoma City	Oklahoma
United States	Investigative Site	Omaha	Nebraska
United States	Investigative Site	Omaha	Nebraska
United States	Investigative Site	Overland Park	Kansas
United States	Investigative Site	Pahrump	Nevada
United States	Investigative Site	Phoenix	Arizona
United States	Investigative Site	Phoenix	Arizona
United States	Investigative Site	Portland	Oregon
United States	Investigative Site	Prairie Village	Kansas
United States	Investigative Site	Salt Lake City	Utah
United States	Investigative Site	San Antonio	Texas
United States	Investigative Site	San Diego	California
United States	Investigative Site	San Francisco	California
United States	Investigative Site	Seattle	Washington
United States	Investigative Site	Shreveport	Louisiana
United States	Investigative Site	Springhill	Florida
United States	Investigative Site	Tampa	Florida
United States	Investigative Site	Torrance	California
United States	Investigative Site	Tucson	Arizona
United States	Investigative Site	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the number of bowel movements over weeks 1-4
Secondary	Change from baseline in the number of bowel movements over weeks 1-12
Secondary	Change from baseline in abdominal distension/bloating over weeks 1-12
Secondary	Change from baseline in abdominal discomfort/pain over weeks 1-12