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

Alkermes

Status and phase

Completed

Phase 2

Conditions

OIC

Treatments

Drug: Placebo

Drug: ALKS 37

Study type

Interventional

Funder types

Industry

Identifiers

ALK37-007

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC.

Enrollment

91 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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