Bowel Dysfunction
Conditions
Keywords
Opioid-induced bowel dysfunction
Brief summary
This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous methylnaltrexone to be conducted in patients with advanced medical illness and poorly controlled opioid induced constipation. Patients will be randomized to one of three fixed dose levels of SC MNTX.
Interventions
DRUGSC MNTX
Dose 1
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must have advanced medical illness (cancer, HIV, etc) and be receiving palliative care 2. Must be on opioid medication for at least 2 weeks with no expectation of significant change in regimen 3. Must have constipation 4. Must be 18 yrs or older
Exclusion criteria
1. Concurrent use of medications other than opioids which might interfere with gastrointestinal motility 2. Patients who received any experimental drug in the last 30 days 3. Patients with active peritoneal cancer (ovarian, etc.) 4. Patients with active diverticulitis or diverticulosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects who have a bowel movement within four hours of dosing | Up to 4 weeks | To access the efficacy of various fixed unit doses of MNTX SC in patients with advanced medical illnesses and poorly controlled opioid-induced constipation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subject with Adverse Events | Up to 4 weeks | To access the tolerability of various fixed unit doses of MNTX SC in patients with advanced medical illnesses and poorly controlled opioid-induced constipation. |
Countries
United States
Outcome results
None listed