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

Colonic Inertia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00949377
• Other study ID #: 064-09
• Status: Withdrawn
• Phase: Phase 4
• First received: July 29, 2009
• Last updated: October 13, 2015
• Start date: September 2009
• Est. completion date: December 2011

Study information

• Verified date: April 2015
• Source: Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Inertia
• Constipation

Intervention

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.
• Placebo
Normal saline

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Medical Center	Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laxation		4 hours	No
Secondary	Opioid withdrawal symptoms		36 hours	Yes