Clinical trial NCT00399659: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Opioid-induced Constipation
Keywords: Opioid, constipation, tegaserod
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-11-15
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Long term safety of tegaserod
Secondary outcomes:
measure: Change from baseline assessment of OIC symptoms, at week 24 and 52
measure: Change from baseline assessment of opioid-induced mid/upper GI symptoms, at week 24 and 52
measure: Patients' weekly assessment of intensity of pain for which opioids were prescribed, at week 24 and 52
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Investigative Site
state: Alabama
city: Phoenix
country: United States
facility: Investigative Site
state: Arizona
city: Phoenix
country: United States
facility: Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Investigative Site
state: Arizona
city: North Little Rock
country: United States
facility: Investigative Site
state: Arkansas
city: Buena Park
country: United States
facility: Investigative Site
state: California
city: Downey
country: United States
facility: Investigative Site
state: California
city: Encinitas
country: United States
facility: Investigative Site
state: California
city: Fountain Valley
country: United States
facility: Investigative Site
state: California
city: La Jolla
country: United States
facility: Investigative Site
state: California
city: Los Angeles
country: United States
facility: Investigative Site
state: California
city: Mission Viejo
country: United States
facility: Investigative Site
state: California
city: Monroe
country: United States
facility: Investigative Site
state: California
city: San Diego
country: United States
facility: Investigative Site
state: California
city: San Diego
country: United States
facility: Investigative Site
state: California
city: San Francisco
country: United States
facility: Investigative Site
state: California
city: Torrance
country: United States
facility: Investigative Site
state: California
city: Northglenn
country: United States
facility: Investigative Site
state: Colorado
city: Bristol
country: United States
facility: Investigative Site
state: Connecticut
city: DeLande
country: United States
facility: Investigative Site
state: Florida
city: Jacksonville
country: United States
facility: Investigative Site
state: Florida
city: Largo
country: United States
facility: Investigative Site
state: Florida
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: New Smyrna Beach
country: United States
facility: Investigative Site
state: Florida
city: Sarasota
country: United States
facility: Investigative Site
state: Florida
city: Springhill
country: United States
facility: Investigative Site
state: Florida
city: Tampa
country: United States
facility: Investigative Site
state: Florida
city: Belleville
country: United States
facility: Investigative Site
state: Illinois
city: Chicago
country: United States
facility: Investigative Site
state: Illinois
city: Avon
country: United States
facility: Investigative Site
state: Indiana
city: Evansville
country: United States
facility: Investigative Site
state: Indiana
city: Indianapolis
country: United States
facility: Investigative Site
state: Indiana
city: Overland Park
country: United States
facility: Investigative Site
state: Kansas
city: Prairie Village
country: United States
facility: Investigative Site
state: Kansas
city: Topeka
country: United States
facility: Investigative Site
state: Kansas
city: Shreveport
country: United States
facility: Investigative Site
state: Louisiana
city: Boston
country: United States
facility: Investigative Site
state: Massachusetts
city: Boston
country: United States
facility: Investigative Site
state: Massachusetts
city: Wellesley Hills
country: United States
facility: Investigative Site
state: Massachusetts
city: Omaha
country: United States
facility: Investigative Site
state: Nebraska
city: Omaha
country: United States
facility: Investigative Site
state: Nebraska
city: Pahrump
country: United States
facility: Investigative Site
state: Nevada
city: New York City
country: United States
facility: Investigative Site
state: New York
city: New York
country: United States
facility: Investigative Site
state: New York
city: North Massapequa
country: United States
facility: Investigative Site
state: New York
city: Charlotte
country: United States
facility: Investigative Site
state: North Carolina
city: Greensboro
country: United States
facility: Investigative Site
state: North Carolina
city: Winston Salem
country: United States
facility: Investigative Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Investigative Site
state: Oklahoma
city: Levittown
country: United States
facility: Investigative Site
state: Pennsylvania
city: Chattanooga
country: United States
facility: Investigative Site
state: Tennessee
city: Beaumont
country: United States
facility: Investigative Site
state: Texas
city: Corsicana
country: United States
facility: Investigative Site
state: Texas
city: Houston
country: United States
facility: Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: Investigative Site
state: Utah
city: Charlottesville
country: United States
facility: Investigative Site
state: Virginia
city: Seattle
country: United States
facility: Investigative Site
state: Washington
Study officials:
affiliation: NPC
name: Novartis Pharmaceuticals Corp.
role: STUDY_CHAIR
References: