Opioid-Induced Constipation
Conditions
Keywords
opioid induced constipation, Cancer patients, methylnaltrexone
Brief summary
This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.
Interventions
DRUGmethylnaltrexone
DRUGplacebo
Sponsors
Progenics Pharmaceuticals, Inc.
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Is a man or woman aged 18 years or older. * Has a body weight \>= 38 kg. * Has cancer (active or in remission), and has cancer-related pain (ie, pain due to cancer or treatment of cancer). * Has a life expectancy of \>= 6 months. * Has a performance status of 0, 1, or 2 based on the Eastern Cooperative Oncology Group (ECOG) scale. * Is taking opioids for cancer-related pain, and not just as-needed doses. * Has a diagnosis of OIC as determined by the investigator. * Is willing to follow the protocol instructions on laxative use during the study.
Exclusion criteria
* Has a history of chronic constipation before starting opioids. * Has renal disease receiving dialysis. * Has an ostomy for stools. * Is a pregnant or breastfeeding woman.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments. | 1 Day |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bowel movements within 4 hours after at least 2 of the first 4 doses. 2. Bowel movements within 4 hours after all doses. 3. The time to bowel movement after the first dose. | 2 weeks |
Countries
Canada, France, Spain, United States
Outcome results
None listed