Can Methylnaltrexone Safely Treat Opioid Related Constipa... | NCT00949377

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

NCT00949377

Sponsor

Beth Israel Medical Center

Status

Withdrawn

Last Update Posted

Oct 14, 2015Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Colonic Inertia

Interventions

Methylnaltrexone Bromide (MNTX)
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to recruit enough patients at a single center.

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jul 29, 2009

First Submission Date that Met QC Criteria

Jul 29, 2009

First Posted Date

Jul 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2015

Last Update Posted Date

Oct 14, 2015Estimated

Name	Class
Wyeth is now a wholly owned subsidiary of Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Methylnaltrexone Bromide	Experimental		Drug: Methylnaltrexone Bromide (MNTX)
Normal Saline	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methylnaltrexone Bromide (MNTX)	Drug	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.

Measure	Description	Time Frame
Laxation		4 hours

Measure	Description	Time Frame
Opioid withdrawal symptoms		36 hours

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Lemeneh Tefera, MD	Beth Israel Medical Center	Principal Investigator
Michael Heller, MD	Beth Israel Medical Center	Study Director

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms