NCT01100151

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

11 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

Study Start

First participant enrolled

April 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 23, 2011

Status Verified

August 1, 2011

Enrollment Period

8 months

First QC Date

April 7, 2010

Last Update Submit

August 18, 2011

Conditions

Opioid-induced Constipation

Keywords

Opioid-induced constipationRDC-1036ALKS 37

Outcome Measures

Primary Outcomes (2)

  • Change in frequency of spontaneous bowel movement (SBM) from pre-treatment period to treatment period

    4 Weeks

  • Number of subjects reporting treatment-emergent adverse events (TEAEs)

    A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).

    6 Weeks

Secondary Outcomes (3)

  • Change in rescue laxative use from pre-treatment to treatment period

    4 Weeks

  • Study drug dose prior to first SBM after randomization

    4 weeks

  • Scores to study-related questionnaires

    6 weeks

Study Arms (2)

RDC-1036 (ALKS 37)

EXPERIMENTAL

Capsules for oral administration

Drug: RDC-1036 (ALKS 37)

Placebo

PLACEBO COMPARATOR

Capsules for oral administration

Drug: Placebo

Interventions

RDC-1036 (ALKS 37)DRUG

Capsules for oral administration

RDC-1036 (ALKS 37)
PlaceboDRUG

Capsules for oral administration

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Alkermes Investigational Site

Sheffield, Alabama, 35660, United States

Location

Alkermes Investigational Site

Anaheim, California, 92801, United States

Location

Alkermes Investigational Site

Pasadena, California, 91105, United States

Location

Alkermes Investigational Site

Walnut Creek, California, 94598, United States

Location

Alkermes Investigational Site

DeLand, Florida, 32734, United States

Location

Alkermes Investigative Site

New Smyrna Beach, Florida, 32168, United States

Location

Alkermes Investigational Site

Boise, Idaho, 83704, United States

Location

Alkermes Investigational Site

New Orleans, Louisiana, 70114, United States

Location

Alkermes Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

Alkermes Investigational Site

Dayton, Ohio, 45432, United States

Location

Alkermes Investigational Site

Salt Lake City, Utah, 84106, 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

  • Bernard L. Silverman, MD

    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

April 7, 2010

First Posted

April 8, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 23, 2011

Record last verified: 2011-08

Locations

US(11)