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Trial record 1 of 1 for:    NCT00949377
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Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?

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ClinicalTrials.gov Identifier: NCT00949377
Recruitment Status : Withdrawn (Unable to recruit enough patients at a single center.)
First Posted : July 30, 2009
Last Update Posted : October 14, 2015
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Beth Israel Medical Center

Tracking Information
First Submitted Date  ICMJE July 29, 2009
First Posted Date  ICMJE July 30, 2009
Last Update Posted Date October 14, 2015
Study Start Date  ICMJE September 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2009)
Laxation [ Time Frame: 4 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2009)
Opioid withdrawal symptoms [ Time Frame: 36 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?
Official Title  ICMJE Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?
Brief Summary The investigators want to prove that people WITHOUT advanced cancer who are taking opioid medications (for problems like back pain) can receive methylnaltrexone (MNTX) safely. Since the FDA has only approved MNTX for advanced cancer patients, the investigators' research is investigating how MNTX can work for NON-cancer patients. This research is being conducted to prove that MNTX can work for non-cancer patients with opioid related constipation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colonic Inertia
Intervention  ICMJE
  • Drug: Methylnaltrexone Bromide (MNTX)
    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.
    Other Name: Relistor
  • Drug: Placebo
    Normal saline
Study Arms  ICMJE
  • Experimental: Methylnaltrexone Bromide
    Intervention: Drug: Methylnaltrexone Bromide (MNTX)
  • Placebo Comparator: Normal Saline
    Intervention: Drug: Placebo
Publications * Not Provided

*   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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 13, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 29, 2009)
60
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Age 18 and greater
  2. Clinical diagnosis of constipation
  3. Any patients that report taking an opioid analgesic for greater than two (2) weeks (eg known oncology patients and chronic pain syndrome patients, including those with low back pain or sciatica)
  4. Patients must have previously tried a stable laxative regiment for at least three (3) days prior to study entry.
  5. All patients will have a flat and upright abdominal x-ray, and chest x-ray to exclude gastrointestinal (GI) obstruction. Any patients who have radiographic evidence of GI obstruction will need a CT scan of the abdomen to exclude GI obstruction prior to study enrollment.
  6. Females of childbearing potential must have a negative pregnancy test and must be encouraged to use appropriate birth control for a period after the study.
  7. Willing to comply with study instructions and sign an informed consent

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Recent surgery within six (6) weeks of the emergency department visit
  3. Opioid withdrawal syndrome as determined by clinical judgment.
  4. Patients with previous history of diabetic gastroparesis.
  5. Any patient who has known or suspected gastrointestinal obstruction
  6. Any patients with creatinine clearance ≤ 30 mL/min
  7. Constipation for which other medical causes cannot be excluded such as anticholinergic medications, botulinum toxin, or botulism.
  8. Any patient with SBP ≤ 80 mmHg or DBP ≤ 45 mmHg or unstable vital signs.
  9. Inability to understand or follow the instructions associated with the clinical study as determined by clinical judgment.
  10. A known history of substance abuse on methadone maintenance therapy > 12 months
  11. Allergy or contraindication to use of methylnaltrexone
  12. Prior enrollment in study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00949377
Other Study ID Numbers  ICMJE 064-09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beth Israel Medical Center
Study Sponsor  ICMJE Beth Israel Medical Center
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Lemeneh Tefera, MD Beth Israel Medical Center
Study Director: Michael Heller, MD Beth Israel Medical Center
PRS Account Beth Israel Medical Center
Verification Date April 2015

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