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Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?

Primary Purpose

Colonic Inertia

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Methylnaltrexone Bromide (MNTX)

Placebo

Sponsored by

Beth Israel Medical Center

About this trial

This is an interventional treatment trial for Colonic Inertia focused on measuring Constipation, opioid

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

Age 18 and greater
Clinical diagnosis of constipation
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)
Patients must have previously tried a stable laxative regiment for at least three (3) days prior to study entry.
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.
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.
Willing to comply with study instructions and sign an informed consent

Exclusion Criteria:

Pregnancy or lactation
Recent surgery within six (6) weeks of the emergency department visit
Opioid withdrawal syndrome as determined by clinical judgment.
Patients with previous history of diabetic gastroparesis.
Any patient who has known or suspected gastrointestinal obstruction
Any patients with creatinine clearance ≤ 30 mL/min
Constipation for which other medical causes cannot be excluded such as anticholinergic medications, botulinum toxin, or botulism.
Any patient with SBP ≤ 80 mmHg or DBP ≤ 45 mmHg or unstable vital signs.
Inability to understand or follow the instructions associated with the clinical study as determined by clinical judgment.
A known history of substance abuse on methadone maintenance therapy > 12 months
Allergy or contraindication to use of methylnaltrexone
Prior enrollment in study

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methylnaltrexone Bromide

Normal Saline

Arm Description

Outcomes

Primary Outcome Measures

Laxation

Secondary Outcome Measures

Opioid withdrawal symptoms

Full Information

NCT ID

First Posted

July 29, 2009

Last Updated

October 13, 2015

Sponsor

Beth Israel Medical Center

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00949377

Brief Title

Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?

Official Title

Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Unable to recruit enough patients at a single center.

Study Start Date

September 2009 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beth Israel Medical Center

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colonic Inertia

Keywords

Constipation, opioid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Methylnaltrexone Bromide

Arm Type

Experimental

Arm Title

Normal Saline

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Methylnaltrexone Bromide (MNTX)

Other Intervention Name(s)

Relistor

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Normal saline

Primary Outcome Measure Information:

Title

Laxation

Time Frame

4 hours

Secondary Outcome Measure Information:

Title

Opioid withdrawal symptoms

Time Frame

36 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Age 18 and greater Clinical diagnosis of constipation 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) Patients must have previously tried a stable laxative regiment for at least three (3) days prior to study entry. 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. 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. Willing to comply with study instructions and sign an informed consent Exclusion Criteria: Pregnancy or lactation Recent surgery within six (6) weeks of the emergency department visit Opioid withdrawal syndrome as determined by clinical judgment. Patients with previous history of diabetic gastroparesis. Any patient who has known or suspected gastrointestinal obstruction Any patients with creatinine clearance ≤ 30 mL/min Constipation for which other medical causes cannot be excluded such as anticholinergic medications, botulinum toxin, or botulism. Any patient with SBP ≤ 80 mmHg or DBP ≤ 45 mmHg or unstable vital signs. Inability to understand or follow the instructions associated with the clinical study as determined by clinical judgment. A known history of substance abuse on methadone maintenance therapy > 12 months Allergy or contraindication to use of methylnaltrexone Prior enrollment in study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lemeneh Tefera, MD

Organizational Affiliation

Beth Israel Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Michael Heller, MD

Organizational Affiliation

Beth Israel Medical Center

Official's Role

Study Director

12. IPD Sharing Statement

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Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?

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