Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation

Back to Search
Print
Bookmark Trial

NCT00804141

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35242, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Constipation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now
pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
Learn more ›

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

ConstipationThe Bowel Research Collaborative Data Tracking System Implementation Study
NCT00728975
  1. Vancouver, British Columbia
ALL GENDERS
0+
years
MULTIPLE SITES
ConstipationStudy Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation
NCT00804141
  1. Birmingham, Alabama
  2. Chandler, Arizona
  3. Mesa, Arizona
  4. Mesa, Arizona
  5. Phoenix, Arizona
  6. Phoenix, Arizona
  7. Tempe, Arizona
  8. Tucson, Arizona
  9. Tucson, Arizona
  10. Hot Springs, Arkansas
  11. Garden Grove, California
  12. Laguna Hills, California
  13. Los Gatos, California
  14. Newport Beach, California
  15. Newport Beach, California
  16. Colorado Springs, Colorado
  17. Boca Raton, Florida
  18. Brandon, Florida
  19. Chiefland, Florida
  20. Clearwater, Florida
  21. Daytona Beach, Florida
  22. Fort Myers, Florida
  23. Gainesville, Florida
  24. Jacksonville, Florida
  25. Jacksonville, Florida
  26. Jupiter, Florida
  27. Miami, Florida
  28. Miami, Florida
  29. Ocala, Florida
  30. Ocala, Florida
  31. Ocala, Florida
  32. Orlando, Florida
  33. Ormond Beach, Florida
  34. Port Orange, Florida
  35. Sarasota, Florida
  36. Sarasota, Florida
  37. Tampa, Florida
  38. Tampa, Florida
  39. Vero Beach, Florida
  40. Winter Park, Florida
  41. Chicago, Illinois
  42. Rockford, Illinois
  43. Avon, Indiana
  44. Evansville, Indiana
  45. Indianapolis, Indiana
  46. Indianapolis, Indiana
  47. West Des Moines, Iowa
  48. Madisonville, Kentucky
  49. Hagerstown, Maryland
  50. Hollywood, Maryland
  51. Boston, Massachusetts
  52. Brockton, Massachusetts
  53. Watertown, Massachusetts
  54. Bingham Farms, Michigan
  55. Chesterfield, Michigan
  56. Kalamazoo, Michigan
  57. Traverse City, Michigan
  58. Edina, Minnesota
  59. Biloxi, Mississippi
  60. Jackson, Mississippi
  61. Springfield, Missouri
  62. Omaha, Nebraska
  63. Henderson, Nevada
  64. Las Vegas, Nevada
  65. Las Vegas, Nevada
  66. Las Vegas, Nevada
  67. Elizabeth, New Jersey
  68. Albuquerque, New Mexico
  69. Great Neck, New York
  70. New York, New York
  71. Charlotte, North Carolina
  72. Raleigh, North Carolina
  73. Fargo, North Dakota
  74. Centerville, Ohio
  75. Dayton, Ohio
  76. Oklahoma City, Oklahoma
  77. Medford, Oregon
  78. Portland, Oregon
  79. Altoona, Pennsylvania
  80. Levittown, Pennsylvania
  81. Yardley, Pennsylvania
  82. Cranston, Rhode Island
  83. Huntingdon, Tennessee
  84. Austin, Texas
  85. Beaumont, Texas
  86. Dallas, Texas
  87. Dallas, Texas
  88. Houston, Texas
  89. Hurst, Texas
  90. San Antonio, Texas
  91. San Antonio, Texas
  92. Salt Lake City, Utah
  93. Christiansburg, Virginia
  94. Bellevue, Washington
  95. Broadmeadow, New South Wales
  96. Edmonton, Alberta
  97. Kelowna, British Columbia
  98. Vancouver, British Columbia
  99. Winnipeg, Manitoba
  100. Mount Pearl, Newfoundland and Labrador
  101. Dartmouth, Nova Scotia
  102. Hamilton, Ontario
  103. London, Ontario
  104. Oshawa, Ontario
  105. Sarnia, Ontario
  106. Toronto, Ontario
  107. Mirabel, Quebec
  108. Sainte-Foy, Quebec
  109. Sherbrooke, Quebec
  110. St-Romuald, Quebec
  111. Trois-Rivieres, Quebec
  112. Quebec,
  113. Barranquilla, Atlantico
  114. Bogota, Cundinamarca
  115. Suwon, Kyonggi-do
  116. Seoul, Seoul/Korea
  117. Seoul,
  118. Seoul,
  119. Badalona, Barcelona/Spain
  120. Madrid, Madrid/Spain
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Constipation
Intervention  ICMJE Drug: N-methylnaltrexone bromide (MOA-728)
MOA-728 will be administered as per the dose and schedule specified in the arm.
Other Name: Relistor
Study Arms  ICMJE Experimental: MOA-728 12 mg QD
Participants will receive MOA-728 12 milligrams (mg) SC once daily (QD) for 48 weeks. Dosing could be adjusted to an as needed (PRN) basis with a minimum 1 dose per week and maximum 1 dose per day.
Intervention: Drug: N-methylnaltrexone bromide (MOA-728)
Publications * Webster R, Michna E, Khan A, et al., The long-term efficacy of subcutaneous methylnaltrexone for the treatment of opioid-induced constipation in patients with chronic nonmalignant pain. J. Pain, 12(4), Supplement , Page P70, April 2011

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2010)		1040
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2008)		800
Actual Study Completion Date  ICMJE September 20, 2010
Actual Primary Completion Date September 20, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Colombia,   Korea, Republic of,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00804141
Other Study ID Numbers  ICMJE 3200K1-3358
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bausch Health Americas, Inc.
Study Sponsor  ICMJE Bausch Health Americas, Inc.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Lindsey MathewBausch Health Americas, Inc.
PRS Account Bausch Health Americas, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP