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

Completed · Phase 2 · Has a placebo group

Conditions studied: OIC

In brief

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

Key facts

Study ID

NCT01418092

Run by

Alkermes, Inc.

People needed

91

Starts

2011-09-01

Expected to finish

2012-06-01

Last updated by the study team

2012-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alkermes Investigational Site — Anaheim, California, United States
• Alkermes Investigational Site — Orange, California, United States
• Alkermes Investigational Site — Daytona Beach, Florida, United States
• Alkermes Investigational Site — Plantation, Florida, United States
• Alkermes Investigational Site — Marietta, Georgia, United States
• Alkermes Investigational Site — Indianapolis, Indiana, United States
• Alkermes Investigational Site — Las Vegas, Nevada, United States
• Alkermes Investigational Site — Willingboro, New Jersey, United States
• Alkermes Investigational Site — Raleigh, North Carolina, United States
• Alkermes Investigational Site — Philadelphia, Pennsylvania, United States
• Alkermes Investigational Site — Austin, Texas, United States
• Alkermes Investigational Site — Houston, Texas, United States
• Alkermes Investigational Site — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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