Status:
COMPLETED
ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
Lead Sponsor:
Alkermes, Inc.
Conditions:
OIC
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01418092
Start Date
September 1 2011
End Date
June 1 2012
Last Update
August 7 2012
Active Locations (13)
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1
Alkermes Investigational Site
Anaheim, California, United States, 92804
2
Alkermes Investigational Site
Orange, California, United States, 92868
3
Alkermes Investigational Site
Daytona Beach, Florida, United States, 32117
4
Alkermes Investigational Site
Plantation, Florida, United States, 33317