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

Opioid-induced Constipation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00399659
• Other study ID #: CHTF919N2201E1
• Status: Terminated
• Phase: Phase 3
• First received: November 14, 2006
• Last updated: April 30, 2012
• Start date: November 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 360
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Opioid-induced 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	Corsicana	Texas
United States	Investigative Site	DeLande	Florida
United States	Investigative Site	Downey	California
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	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	California
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	Prairie Village	Kansas
United States	Investigative Site	Salt Lake City	Utah
United States	Investigative Site	San Diego	California
United States	Investigative Site	San Diego	California
United States	Investigative Site	San Francisco	California
United States	Investigative Site	Sarasota	Florida
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	Topeka	Kansas
United States	Investigative Site	Torrance	California
United States	Investigative Site	Tucson	Arizona
United States	Investigative Site	Wellesley Hills	Massachusetts
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	Long term safety of tegaserod
Secondary	Change from baseline assessment of OIC symptoms, at week 24 and 52
Secondary	Change from baseline assessment of opioid-induced mid/upper GI symptoms, at week 24 and 52
Secondary	Patients' weekly assessment of intensity of pain for which opioids were prescribed, at week 24 and 52