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

NCT01418092 | Completed Phase 2 DMC

• 1 other identifier: ALK37-007
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 13

Brief Summary

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

Conditions

OIC

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the weekly average of complete spontaneous bowel movements during treatment

  Weeks 1 through 4 of treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Capsules for oral administration

Drug: Placebo

ALKS 37

EXPERIMENTAL

Capsules for oral administration

Drug: ALKS 37

Interventions

ALKS 37 DRUG

Capsules for oral administration

ALKS 37

Placebo DRUG

Capsules for oral administration

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (13)

Alkermes Investigational Site

Anaheim, California, 92804, United States

Location

Alkermes Investigational Site

Orange, California, 92868, United States

Location

Alkermes Investigational Site

Daytona Beach, Florida, 32117, United States

Location

Alkermes Investigational Site

Plantation, Florida, 33317, United States

Location

Alkermes Investigational Site

Marietta, Georgia, 30060, United States

Location

Alkermes Investigational Site

Indianapolis, Indiana, 46250, United States

Location

Alkermes Investigational Site

Las Vegas, Nevada, 89119, United States

Location

Alkermes Investigational Site

Willingboro, New Jersey, 08046, United States

Location

Alkermes Investigational Site

Raleigh, North Carolina, 27612, United States

Location

Alkermes Investigational Site

Philadelphia, Pennsylvania, 19139, United States

Location

Alkermes Investigational Site

Austin, Texas, 78756, United States

Location

Alkermes Investigational Site

Houston, Texas, 77098, United States

Location

Alkermes Investigational Site

Bellevue, Washington, 98007, United States

Location

Study Officials

• Richard Leigh-Pemberton, M.D.

  Alkermes, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 16, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 7, 2012

Record last verified: 2012-07

Locations

US (13)