Overview

ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)

Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alkermes, Inc.
Criteria
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