Advanced Illness Patients With Opioid Induced Constipation
Conditions
Brief summary
To test the effectiveness of MNTX in advanced illness subjects.
Detailed description
To determine the efficacy of MNTX compared to placebo to induce laxation in patients receiving opioids.
Interventions
Dose 1
DRUGSC Placebo
Sponsors
Pfizer
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Advanced medical illness with a life expectancy of 1 to 6 months 2. No clinically significant laxation within 48 hours prior to the first dose of study drug 3. On stable opioid and laxative regimen for a least 3 days prior to treatment 4. Age greater than 18years 5. Females of child-bearing age must have a negative pregnancy test.
Exclusion criteria
1. Females who are pregnant or nursing. 2. Previous treatment with MNTX or prior treatment with naltrexone or naloxone for treatment of OIC 3. Any disease process suggestive of gastrointestinal obstruction 4. Fecal ostomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of SC MNTX compared with placebo in inducing laxation | 29 days | The primary objective is to determine the efficacy of SC MNTX administered as a single dose, dose 1 and dose 2 compared with placebo in inducing laxation in 4 hours in patients with advanced medical illness and OIC who are poorly responsive to laxatives. |
Countries
United States
Outcome results
None listed