NCT01382797

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of ALKS 37 when administered daily for 4 weeks to adults with Opioid-induced Constipation (OIC).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

Enrollment Period

8 months

First QC Date

June 24, 2011

Last Update Submit

June 12, 2012

Conditions

Opioid-induced Constipation

Outcome Measures

Primary Outcomes (1)

  • Dose response relationship among five doses of study drug (4 doses of ALKS 37 and placebo), defined as an increasing proportion of patients exhibiting overall response.

    Overall response will be defined using an algorithm that takes into consideration number of complete spontaneous bowel movements, improvement from baseline, and durability of response.

    4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Capsules for oral administration

Drug: Placebo

ALKS 37

EXPERIMENTAL

Capsules for oral administration

Drug: ALKS 37

Interventions

ALKS 37DRUG

Capsules for oral administration

ALKS 37
PlaceboDRUG

Capsules for oral administration

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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, 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Alkermes Study Site

Mesa, Arizona, 85206, United States

Location

Alkermes Study Site

Phoenix, Arizona, 85053, United States

Location

Alkermes Study Site

National City, California, 91950, United States

Location

Alkermes Study Site

Oceanside, California, 92056, United States

Location

Alkermes Study Site

Pasadena, California, 91105, United States

Location

Alkermes Study Site

Denver, Colorado, 80211, United States

Location

Alkermes Investigational Site

DeLand, Florida, 32724, United States

Location

Alkermes Study Site

Ormond Beach, Florida, 32174, United States

Location

Alkermes Study Site

St. Petersburg, Florida, 33709, United States

Location

Alkermes Study Site

Stockbridge, Georgia, 30281, United States

Location

Alkermes Study Site

Boise, Idaho, 83704, United States

Location

Alkermes Study Site

New Orleans, Louisiana, 70114, United States

Location

Alkermes Study Site

Kalamazoo, Michigan, 49009, United States

Location

Alkermes Study Site

Las Vegas, Nevada, 89144, United States

Location

Alkermes Study Site

Belvidere, New Jersey, 07823, United States

Location

Alkermes Study Site

Brooklyn, New York, 11218, United States

Location

Alkermes Study Site

Cincinnati, Ohio, 45224, United States

Location

Alkermes Study Site

Oklahoma City, Oklahoma, 73134, United States

Location

Alkermes Study Site

Medford, Oregon, 97504, United States

Location

Alkermes Study Site

San Antonio, Texas, 78228, United States

Location

MeSH Terms

Conditions

Opioid-Induced Constipation

Condition Hierarchy (Ancestors)

ConstipationSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2011

First Posted

June 27, 2011

Study Start

August 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations

US(20)