Clinical trial NCT00804141: Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation
Official title: An Open-Label Study to Evaluate the Long-Term Safety of Subcutaneous MOA-728 for Treatment of Opioid-Induced Constipation in Subjects With Nonmalignant Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Constipation
Keywords: treatment for opioid-induced constipation
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2008-12-08
Enrollment: 1040
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the long-term safety and tolerability of the subcutaneous (SC) injection form of N-methylnaltrexone bromide (MOA-728) for the treatment of opioid-induced constipation in participants with nonmalignant pain. The study consists of a 2-week screening period, a 48-week open-label treatment period and a 2 week follow-up period. Participants will need to agree to self-administer SC injections, complete daily diaries, and check-in via a daily telephone call during the study.


Eligibility criteria: Inclusion Criteria:

* Men and women 18 years or older.
* A history of pain of at least 2 months duration before the screening visit due to documented underlying nonmalignant condition.
* A history of constipation due to opioid use during 1 month before the screening visit.

Exclusion Criteria:

* A diagnosis of significant gastrointestinal (GI) disorder such as bowel obstruction, fecal incontinence or rectal prolapse.
* A history of active inflammatory bowel disease, irritable bowel syndrome, or megacolon within 6 months before the screening visit.
* A history of malignancy, other than basal cell or squamous cell skin carcinoma, within 5 years before the screening visit.
* A history of chronic constipation before initiation of opioid therapy.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Week 50
Secondary outcomes:
measure: Change From Baseline in Weekly Bowel Movement (BM) Rate Through Follow-up
timeFrame: Baseline, follow-up (14 days [Week 49 to 50])
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Chandler
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tempe
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Hot Springs
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Garden Grove
country: United States
facility: Pfizer Investigational Site
state: California
city: Laguna Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Gatos
country: United States
facility: Pfizer Investigational Site
state: California
city: Newport Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Newport Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Boca Raton
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Brandon
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chiefland
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Daytona Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jupiter
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Port Orange
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Vero Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Winter Park
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Rockford
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Avon
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: West Des Moines
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Madisonville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Hagerstown
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Brockton
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Watertown
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Bingham Farms
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Chesterfield
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Traverse City
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Edina
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Biloxi
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Henderson
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Elizabeth
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Great Neck
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Centerville
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Altoona
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Levittown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Yardley
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Cranston
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Huntingdon
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Hurst
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Christiansburg
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Bellevue
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Broadmeadow
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Mount Pearl
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: Dartmouth
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Mirabel
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: St-Romuald
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Barranquilla
country: Colombia
facility: Pfizer Investigational Site
state: Atlantico
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Suwon
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Kyonggi-do
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Seoul/Korea
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Badalona
country: Spain
facility: Pfizer Investigational Site
state: Barcelona/Spain
city: Madrid
country: Spain
facility: Pfizer Investigational Site
state: Madrid/Spain
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Lindsey Mathew
role: STUDY_DIRECTOR
References:
citation: Michna E, Blonsky ER, Schulman S, Tzanis E, Manley A, Zhang H, Iyer S, Randazzo B. Subcutaneous methylnaltrexone for treatment of opioid-induced constipation in patients with chronic, nonmalignant pain: a randomized controlled study. J Pain. 2011 May;12(5):554-62. doi: 10.1016/j.jpain.2010.11.008. Epub 2011 Mar 22.