Clinical trial NCT00529087: Study Evaluating Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic Non-Malignant Pain
Official title: A Mulitcenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation in Subjects With Chronic Non-Malignant Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Constipation
Keywords: Opioid-Induced Constipation
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Progenics Pharmaceuticals, Inc.
First posted: 2007-09-14
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC).


Eligibility criteria: Inclusion Criteria:

* Adult outpatients with opioid-induced constipation and chronic non-malignant pain.
* Taking oral, transdermal, intravenous, or subcutaneous opioids.
* Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

Exclusion Criteria

* History of chronic constipation before the initiation of opioid therapy.
* Other GI disorders known to affect bowel transit.
* Women who are pregnant, breast-feeding, or plan to become pregnant.

Primary outcomes:
measure: Percentage of Patients Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours of the First Dose
timeFrame: up to 4 hours
measure: Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 4 Hours of Injection During the Double-blind Period
timeFrame: 4 weeks
Secondary outcomes:
measure: Time to the First Rescue-free Bowel Movement (RFBM) After First Dose
timeFrame: up to 24 hours
measure: Change From Baseline in Weekly Number of Rescue-free Bowel Movements (RFBM) for the Double-blind Period at 4 Weeks
timeFrame: Baseline and 4 weeks
measure: Weekly Number of Rescue-free Bowel Movements (RFBM) (Open-label Period)
timeFrame: 8 weeks
measure: Percentage of Patients Achieving at Least 3 Rescue-free Bowel Movements (RFBM) Per Week in Double-blind Period
timeFrame: 4 weeks
measure: Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 1, 2, 3 and 6 Hour(s) in Double-blind Period
timeFrame: Within 1-6 hours during 4 week double-blind period
measure: Percentage of Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 1, 2, 3, 4 and 6 Hours in Double-blind Period
timeFrame: Within 1-6 hours during 4-week double-blind period
measure: Percentage of Patients With a Weekly Rescue-free Bowel Movement (RFBM) Rate ≥ 3 and an Increase of at Least 1 in the Weekly RFBM Rate From Baseline for the Double-blind Period
timeFrame: 4 weeks
measure: Percentage of Patients With an Increase of at Least 1 in the Weekly Rescue-free Bowel Movement (RFBM) Rate From Baseline for the Double-blind Period at 4 Weeks
timeFrame: Baseline and 4 weeks
measure: Change in Weekly Number of Bowel Movements During Double-blind Period
timeFrame: 4 weeks
measure: Change From Baseline in Weekly Number of Quality Rescue-free Bowel Movements (RFBM)
timeFrame: 4 weeks
measure: Change in Weekly Number of Complete Rescue-free Bowel Movements (RFBM)
timeFrame: 4 weeks
measure: Change in Bristol Stool Form Scale Score for Rescue-free Bowel Movements (RFBM)
timeFrame: 4 weeks
measure: Change in Straining Scale Score of Rescue-free Bowel Movements (RFBM) From Baseline During Double-blind Period
timeFrame: 4 weeks
measure: Percentage of Patients With Improvement in Bristol Stool Form Scale Score for Rescue-free Bowel Movements (RFBM) by 1 Point During Open Label Period
timeFrame: 8 weeks
measure: Percentage of Patients With Improvement in Straining Scale Score for Rescue-free Bowel Movements (RFBM) by 1 Point During Open Label Period
timeFrame: 8 weeks
measure: Change in Percentage of Rescue-free Bowel Movements (RFBM) With Bristol Stool Form Scale in Type 3 or Type 4 From Baseline During Double-blind Period
timeFrame: 4 weeks
measure: Change in Percentage of Rescue-free Bowel Movements (RFBM) Classified as Diarrhea or Watery Stools From Baseline During Double-blind Period
timeFrame: 4 weeks
measure: Percentage of Patients With Any Diarrhea or Watery Rescue-free Bowel Movements (RFBM) During Open-label Period.
timeFrame: weeks 5-12
measure: Change in Percentage of Rescue-free Bowel Movements (RFBM) With Straining Scale Scores of 0 or 1 (no, or Mild) From Baseline During Double-blind Period
timeFrame: 4 weeks
measure: Change in Percentage of Rescue-free Bowel Movements (RFBM) With a Sensation of Complete Evacuation From Baseline During Double-blind Period
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Sun City
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Hot Springs
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Hawaiian Gardens
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Brandon
country: United States
state: Florida
city: Cheifland
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Spring Hill
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Stockbridge
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: DeKalb
country: United States
state: Illinois
city: Avon
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: West Des Moines
country: United States
state: Iowa
city: Shreveport
country: United States
state: Louisiana
city: Sunset
country: United States
state: Louisiana
city: Elkridge
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Brockton
country: United States
state: Massachusetts
city: Cadillac
country: United States
state: Michigan
city: Paw Paw
country: United States
state: Michigan
city: Traverse City
country: United States
state: Michigan
city: Biloxi
country: United States
state: Mississippi
city: Ocean Springs
country: United States
state: Mississippi
city: Nixa
country: United States
state: Missouri
city: Kalispell
country: United States
state: Montana
city: Missoula
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Albuquerque
country: United States
state: New Mexico
city: Great Neck
country: United States
state: New York
city: Valley Stream
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Dayton
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Levittown
country: United States
state: Pennsylvania
city: Chattanooga
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Beaumont
country: United States
state: Texas
city: Colleyville
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Alexandria
country: United States
state: Virginia
city: Christiansburg
country: United States
state: Virginia
city: Hampton
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Charleston
country: United States
state: West Virginia
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Jeff Cohn
role: STUDY_DIRECTOR
References:
citation: Liao SS, Slatkin NE, Stambler N. The Influence of Age on Central Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation. Drugs Aging. 2021 Jun;38(6):503-511. doi: 10.1007/s40266-021-00850-w. Epub 2021 Mar 31.
citation: Michna E, Weil AJ, Duerden M, Schulman S, Wang W, Tzanis E, Zhang H, Yu D, Manley A, Randazzo B. Efficacy of subcutaneous methylnaltrexone in the treatment of opioid-induced constipation: a responder post hoc analysis. Pain Med. 2011 Aug;12(8):1223-30. doi: 10.1111/j.1526-4637.2011.01189.x. Epub 2011 Aug 2.