Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures
NCT00640146
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1. Male and female participants greater than or equal to (>=) 18 years of age.
2. Participants must have undergone an orthopedic procedure (that is, total knee or hip replacement, spinal fusion, or reduction of fracture(s) with or without surgical fixation post trauma).
3. Participants must be receiving opioid analgesics (a mu agonist only-not to include agents with mixed mechanisms of action such as tramadol or buprenorphine) after the procedures and be expected to require daily opioid analgesics for at least 7 days post randomization.
4. Participants must be acutely constipated following their orthopedic procedure.
5. Participants must receive all doses of study drug in either hospitals or rehabilitation facilities.
6. Participants must sign an informed consent form.
7. Females of childbearing potential must have a negative pregnancy test and use appropriate birth control throughout the study.
8. Body weight within range of 40 kilograms (kg) - 150 kg (88 - 330 pounds [lbs]).
1. Participants with known hypersensitivity to methylnaltrexone, naltrexone, or naloxone.
2. Participants who received any investigational new drug (experimental) in the previous
30 days.
3. Participants who have received a laxative (for example, lactulose) or an enema within
48 hours prior to the first dose.
4. Participants with constipation not attributed to post procedure opioids.
5. Participants with a history of alcohol or prescription or non-prescription drug abuse
within the past 2 years.
6. Female participants who are pregnant or lactating.
7. Participants with a known history of chronic active hepatitis B or hepatitis C virus
or human immunodeficiency virus (HIV) infection.
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Descriptive Information | ||||
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Brief Title ICMJE | Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures | |||
Official Title ICMJE | A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled Phase 2 Study of Once-Daily Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures | |||
Brief Summary | The purpose of this study is to examine the safety and activity of MNTX in relieving opioid-induced constipation following orthopedic procedures. | |||
Detailed Description | This is a double-blind, randomized, parallel-group, placebo- controlled Phase 2 study to evaluate the safety and activity of subcutaneous (SC) MNTX versus SC placebo in participants who have undergone orthopedic procedures and who are expected to require opioids for 1 week after randomization. Participants will sign an informed consent form and be screened between Days 4-10 after their orthopedic procedure. Those participants who meet all eligibility requirements will be enrolled in the study. Treatment with study medication will be continued until either the participant no longer requires opioid medication for pain relief or the maximum number of doses is reached. Originally, participants were receiving treatment for up to 7 days. Then after Protocol Amendment 1 (12 March 2008), the duration of treatment changed from "up to 7 days" to "up to 4 days". | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Opioid-induced Constipation | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Anissian L, Schwartz HW, Vincent K, Vincent HK, Carpenito J, Stambler N, Ramakrishna T. Subcutaneous methylnaltrexone for treatment of acute opioid-induced constipation: phase 2 study in rehabilitation after orthopedic surgery. J Hosp Med. 2012 Feb;7(2):67-72. doi: 10.1002/jhm.943. Epub 2011 Oct 13. | |||
* 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 | 37 | |||
Original Estimated Enrollment ICMJE | 260 | |||
Actual Study Completion Date ICMJE | January 21, 2009 | |||
Actual Primary Completion Date | January 21, 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00640146 | |||
Other Study ID Numbers ICMJE | MNTX2101 | |||
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 | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Investigators ICMJE |
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PRS Account | Bausch Health Americas, Inc. | |||
Verification Date | August 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |