ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
- Registration Number
- NCT01418092
- Lead Sponsor
- Alkermes, Inc.
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Placebo Capsules for oral administration ALKS 37 ALKS 37 Capsules for oral administration
- Primary Outcome Measures
Name Time Method Change from baseline in the weekly average of complete spontaneous bowel movements during treatment Weeks 1 through 4 of treatment
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of ALKS 37 in treating opioid-induced constipation?
How does ALKS 37 compare to standard-of-care treatments for OIC in terms of efficacy and safety?
Are there specific biomarkers that predict patient response to ALKS 37 therapy for OIC?
What adverse events were observed in the NCT01418092 trial and how were they managed?
What are the current developments in competitive drug classes for opioid-induced constipation?
Trial Locations
- Locations (1)
Alkermes Investigational Site
🇺🇸Bellevue, Washington, United States
Alkermes Investigational Site🇺🇸Bellevue, Washington, United States