Clinical trial NCT00365820: 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
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Constipation
Keywords: Opioid, constipation, tegaserod
Opioid-induced constipation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-08-18
Enrollment: 670
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in the number of bowel movements over weeks 1-4
Secondary outcomes:
measure: Change from baseline in the number of bowel movements over weeks 1-12
measure: Change from baseline in abdominal distension/bloating over weeks 1-12
measure: Change from baseline in abdominal discomfort/pain over weeks 1-12
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: 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: DeLand
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: 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: 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: 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: East Hanover
country: United States
facility: Novartis Pharmaceutical Corporation
state: New Jersey
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: Monroe
country: United States
facility: Investigative Site
state: North Carolina
city: Winston Salem
country: United States
facility: Investigative Site
state: North Carolina
city: Dayton
country: United States
facility: Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Investigative Site
state: Oklahoma
city: Portland
country: United States
facility: Investigative Site
state: Oregon
city: Hershey
country: United States
facility: Investigative Site
state: Pennsylvania
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: Colleyville
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: San Antonio
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: Novartis Pharmaceuticals
name: Novartis Pharma AG
role: STUDY_CHAIR
References: