OIC
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC.
Interventions
DRUGALKS 37
Capsules for oral administration
DRUGPlacebo
Capsules for oral administration
Sponsors
Alkermes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are at least 18 years of age at time of consent * Have a body mass index (BMI)of 19 to 35 kg/m2 at screening * Are receiving prescribed opioid medication for the management of chronic, non-cancer pain * Meet the criteria of OIC * Agree to use an acceptable method of contraception for the duration of the study
Exclusion criteria
* Pregnancy and/or currently breastfeeding * Clinically significant medical condition or illness (other than the condition for which the pain medication is being prescribed) * Receiving treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction * Any gastrointestinal (GI) disorder (other than opioid-induced constipation) or GI structural abnormality known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfunction * Use of naloxone, Subutex or Suboxone, Revia, Vivitrol, Relistor, or Entereg starting 15 days before the first study visit following screening until the end of the study * Participation in a clinical trial of a pharmacological agent within 30 days before screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the weekly average of complete spontaneous bowel movements during treatment | Weeks 1 through 4 of treatment |
Countries
United States
Outcome results
None listed