- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01050595
Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit (MOVE-IT)
January 13, 2010 updated by: St. John Health System, Michigan
Methylnaltrexone for the Reversal of Opiate-Induced Constipation in the Intensive Care Unit
The purpose of this study is to determine if there will be a significantly higher incidence of a bowel movement with methylnaltrexone vs. placebo within 4 hours +- 45 minutes with decreased need for rescue medications in the intensive care unit in patients with opioid-induced constipation.
Patients will also be managed with an aggressive bowel management protocol.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bradford A Whitmer, D.O.
- Phone Number: 2482891272
- Email: whitmer5@msu.edu
Study Locations
-
-
Michigan
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Southfield, Michigan, United States, 48075
- Recruiting
- Providence Hospital and Medical Center
-
Contact:
- Lynne C Paul, Rn, MSN
- Phone Number: 248-849-5805
- Email: lynne.paul@stjohn.org
-
Contact:
- Nicole D Bolda
- Phone Number: 248-849-889
- Email: nicole.bolda@stjohn.org
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Principal Investigator:
- Bradford A Whitmer, DO
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age or older in the ICU
- Opioids for analgesia for at least 24 hours.
- Opioid-induced constipation with no bowel movement within the last 72 hours.
- Women of childbearing potential had negative pregnancy tests.
Exclusion Criteria:
- Contraindication to use of the GI tract
- Diarrhea on admission
- Bowel surgery within 8 weeks of admission
- Ileostomy or colostomy
- Not expected to live or stay more than 3 days in the intensive care unit
- Constipation that was not primarily caused by opioids (as determined by the investigator)
- No opioid use in the last 24 hours,
- Mechanical gastrointestinal obstruction
- An indwelling peritoneal catheter
- Clinically active diverticular disease
- Fecal impaction
- Acute surgical abdomen
- History of Crohn's disease or ulcerative colitis
- On Palliative care
- Less than 18 years old
- Bowel movement in last 72 hours.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
Control group will be given an equal amount of normal saline in an identically appearing vial every other day until a bowel movement occurs.
A bowel management protocol will also be started.
Other Names:
|
ACTIVE_COMPARATOR: Methylnaltrexone Bromide
|
The experimental group will receive the recommended dose of MNTX (Relistor) is 8 mg for patients weighing 38 kg to less than 62 kg (84 lbs to less than 136 lbs) or 12 mg for patients weighing 62 kg to 114 kg (136 lbs to 251 lbs).
Patients whose weight is below 38 kg or greater than 114 kg, will be dosed at 0.15 mg/kg.
If creatinine clearance <30 will decrease dose by 50%.
This will be given after 72 hours of no bowel movement.
Bowel management protocol will be instituted four hours afterward with the methylnaltrexone being given every other day.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
A significantly higher incidence of a rescue free laxation with methylnaltrexone within 4 hours +- 45 minutes.
Time Frame: Nine months
|
Nine months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decreased need for rescue medications to have a bowel movement in the treatment arm vs placebo.
Time Frame: Nine months
|
Nine months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bradford A Whitmer, D.O., Providence Hospital and Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Arpino PA, Thompson BT. Safety of enteral naloxone for the reversal of opiate-induced constipation in the intensive care unit. J Clin Pharm Ther. 2009 Apr;34(2):171-5. doi: 10.1111/j.1365-2710.2008.00982.x.
- Ritchie G, Burgess L, Mostafa S, Wenstone R. Preventing constipation in critically ill patients. Nurs Times. 2008 Nov 18-24;104(46):42-4.
- Patanwala AE, Abarca J, Huckleberry Y, Erstad BL. Pharmacologic management of constipation in the critically ill patient. Pharmacotherapy. 2006 Jul;26(7):896-902. doi: 10.1592/phco.26.7.896.
- Chappell D, Rehm M, Conzen P. Opioid-induced constipation in intensive care patients: relief in sight? Crit Care. 2008;12(4):161. doi: 10.1186/cc6930. Epub 2008 Jul 1.
- Mostafa SM, Bhandari S, Ritchie G, Gratton N, Wenstone R. Constipation and its implications in the critically ill patient. Br J Anaesth. 2003 Dec;91(6):815-9. doi: 10.1093/bja/aeg275.
- Tittle M, McMillan SC. Pain and pain-related side effects in an ICU and on a surgical unit: nurses' management. Am J Crit Care. 1994 Jan;3(1):25-30.
- Viscusi ER, Gan TJ, Leslie JB, Foss JF, Talon MD, Du W, Owens G. Peripherally acting mu-opioid receptor antagonists and postoperative ileus: mechanisms of action and clinical applicability. Anesth Analg. 2009 Jun;108(6):1811-22. doi: 10.1213/ane.0b013e31819e0d3a.
- McKenna S, Wallis M, Brannelly A, Cawood J. The nursing management of diarrhoea and constipation before and after the implementation of a bowel management protocol. Aust Crit Care. 2001 Feb;14(1):10-6. doi: 10.1016/s1036-7314(01)80017-5.
- Dorman BP, Hill C, McGrath M, Mansour A, Dobson D, Pearse T, Singleton J, Al-Omoush A, Barry M, Colongon AR, Perez M, Fitzgerald D, Zabala M. Bowel management in the intensive care unit. Intensive Crit Care Nurs. 2004 Dec;20(6):320-9. doi: 10.1016/j.iccn.2004.09.004.
- Hill S, Anderson J, Baker K, Bonson B, Gager M, Lake E. Management of constipation in the critically ill patient. Nurs Crit Care. 1998 May-Jun;3(3):134-7.
- Sanz Rubiales A, del Valle Rivero ML. Methylnaltrexone for opioid-induced constipation in advanced illness. N Engl J Med. 2008 Sep 4;359(10):1070-1; author reply 1071. doi: 10.1056/NEJMc081373. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (ANTICIPATED)
October 1, 2010
Study Completion (ANTICIPATED)
December 1, 2010
Study Registration Dates
First Submitted
January 13, 2010
First Submitted That Met QC Criteria
January 13, 2010
First Posted (ESTIMATE)
January 15, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
January 15, 2010
Last Update Submitted That Met QC Criteria
January 13, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Signs and Symptoms, Digestive
- Narcotic-Related Disorders
- Constipation
- Opioid-Induced Constipation
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Narcotic Antagonists
- Anticonvulsants
- Alcohol Deterrents
- Naltrexone
- Bromides
- Methylnaltrexone
Other Study ID Numbers
- 107199
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Opioid-induced Constipation
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Amsterdam UMC, location VUmcRadboud University Medical Center; University Medical Center Groningen; UMC Utrecht and other collaboratorsRecruitingConstipation, Opioid-InducedNetherlands
-
Kyowa Kirin Pharmaceutical Development LtdTerminatedOpioid Induced ConstipationNetherlands, United Kingdom
-
Valinor Pharma LLCActive, not recruiting
-
Theravance BiopharmaCompletedOpioid Induced ConstipationUnited States
-
ShionogiRecruitingOpioid-Induced Constipation (OIC)France
-
AstraZenecaCompletedOpioid-Induced Constipation (OIC)United States, Australia, Slovakia, Germany
-
AstraZenecaCompletedOpioid-Induced Constipation (OIC)United States
-
Bausch Health Americas, Inc.Wyeth is now a wholly owned subsidiary of PfizerCompletedOpioid-induced ConstipationUnited States
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Unknown
-
Alkermes, Inc.CompletedOpioid-induced ConstipationUnited States
Clinical Trials on Methylnaltrexone Bromide
-
Bausch Health Americas, Inc.Progenics Pharmaceuticals, Inc.CompletedOpioid-Induced ConstipationUnited States, Australia, Belgium, Canada, France, Germany, Italy, Mexico, Portugal, United Kingdom
-
Bausch Health Americas, Inc.Wyeth is now a wholly owned subsidiary of PfizerCompletedOpioid-induced ConstipationUnited States
-
Bausch Health Americas, Inc.WithdrawnPancreatic CancerUnited States
-
Beth Israel Medical CenterWyeth is now a wholly owned subsidiary of PfizerWithdrawn
-
Bausch Health Americas, Inc.CompletedHealthy Adult SubjectsUnited States
-
Bausch Health Americas, Inc.Progenics Pharmaceuticals, Inc.CompletedConstipationUnited States
-
Bausch Health Americas, Inc.Progenics Pharmaceuticals, Inc.Completed
-
University of VermontCompletedNeoplasms | Constipation | Opioid-Related DisordersUnited States
-
Bausch Health Americas, Inc.Withdrawn
-
Bausch Health Americas, Inc.PfizerCompletedConstipationCanada, United States, Colombia, Korea, Republic of, Australia, Spain