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

NCT00949377 | Withdrawn Phase 4

• 1 other identifier: 064-09
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colonic Inertia

Keywords

Constipation; opioid

Outcome Measures

Primary Outcomes (1)

• Laxation

  4 hours

Secondary Outcomes (1)

• Opioid withdrawal symptoms

  36 hours

Study Arms (2)

Methylnaltrexone Bromide

EXPERIMENTAL

Drug: Methylnaltrexone Bromide (MNTX)

Normal Saline

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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.

Also known as: Relistor

Methylnaltrexone Bromide

Placebo DRUG

Normal saline

Normal Saline

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Medical Center: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

MeSH Terms

Conditions

Constipation

Interventions

methylnaltrexone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lemeneh Tefera, MD

  Beth Israel Medical Center

  PRINCIPAL INVESTIGATOR

• Michael Heller, MD

  Beth Israel Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2009
• First Posted: July 30, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 14, 2015

Record last verified: 2015-04