ALK37-003: A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation (OIC)

Alkermes

Status and phase: Completed; Phase 2

Conditions: Opioid-induced Constipation

Treatments: Drug: RDC-1036 (ALKS 37); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01100151

ALK37-003

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of RDC-1036 (ALKS 37) in adults with opioid-induced constipation (OIC) following repeat dose administration

Full description

Approximately 60 subjects will be enrolled in 1 of 2 cohorts. Following a review of Cohort 1 safety and tolerability data, subjects will then be enrolled into Cohort 2, to explore additional doses. Dose escalation will occur in both cohorts. There will be 18 visits over a 6-week period.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 70 years of age
• Body mass index (BMI) of 19 to 35 kg/m2 at screening
• Receiving prescribed opioid medication for the management of chronic, non-cancer, pain
• Diagnosis of opioid-induced constipation (OIC)
• Willingness to stop all laxatives and other bowel regimens from the first study visit following screening until the end of the study. The use of constipation rescue medication will be allowed during 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) or pelvic disorder known to affect bowel transit, produce a GI obstruction, or contribute to bowel dysfunction other than opioid-induced constipation (eg, diverticulitis, other intestinal strictures, bezoars)
• Use of medical devices such as pacemakers, infusion pumps, or insulin pumps
• Use of naloxone, Subutex or Suboxone, Revia, 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

RDC-1036 (ALKS 37)

Experimental group

Description:

Capsules for oral administration

Treatment:

Drug: RDC-1036 (ALKS 37)

Placebo

Placebo Comparator group

Description:

Capsules for oral administration

Treatment:

Drug: Placebo