Advance Illness Patients With OIC
Conditions
Brief summary
To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.
Detailed description
This is a multi-center, double-blind, randomized parallel group study conducted in patients with advanced medical illness and opioid-induced constipation. Eligible patients are randomly assigned to receive SC doses of either MNTX, dose 1 or placebo every other day for 2 weeks. At Day 8, eligible patients, if allowed, could be escalated to a a higher dose of MNTX.
Interventions
Dose 1
DRUGSC Placebo
Sponsors
Wyeth is now a wholly owned subsidiary of 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
* 18 years of age and older * Negative pregnancy test (serum or urine) at screening for all women of childbearing potential * Advanced Medical Illness (i.e., terminal illness, such as incurable cancer or end of stage AIDS) with life expectancy of ≥ 1 month * patient must sign ICF
Exclusion criteria
* Women who are pregnant and/or nursing * Previous treatment with MNTX * Participation in any other studies involving investigational products within 30 days prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Laxation within four hours of a single dose of SC MNTX and efficacy of SC MNTX every other day over a 1 week period. | 2 weeks | To determine the efficacy of a single dose of SC MNTX compared with placebo in inducing laxation within 4 hours. To determine the efficacy of SC MNTX every other day over a 1-week treatment period in relieving OIC in patients with AMI. |
Countries
United States
Outcome results
None listed