Study Evaluating The Efficacy And Safety Of Subcutaneous MOA-728 For The Treatment Of Opioid-Induced-Constipation

This study has been completed.
Sponsor:
Collaborator:
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00936884
First received: July 8, 2009
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

The primary purpose of this study is to evaluate the safety, efficacy, and tolerability of subcutaneous (injection beneath the skin) MOA-728 versus placebo in Asian Adult subjects with opioid-induced constipation and advanced illness


Condition Intervention Phase
Constipation
Drug: MOA728
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, And Parallel-Group Study Of Subcutaneous MOA-728 For The Treatment Of Opioid-Induced Constipation In Adult Subjects

Resource links provided by NLM:


Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • The proportion of subjects having a rescue-free bowel movement (RFBM) within 4 hours after the first injection, and after each dose during DB period. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of injection resulting in RFBM within 4 hours after test article administration. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 51
Study Start Date: July 2009
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MOA728 QOD
Drug: MOA728
  1. 0.6 ml (12 mg), qod if weight=>62kg;
  2. 0.4ml (8 mg), qod if weight between 38 and <62;
  3. 0.0075ml/kg (0.15mg/kg), qod if weight between 27 and <38kg; study duration: 2 weeks
Placebo Comparator: 2
Placebo QOD
Drug: MOA728
  1. 0.6 ml, qod if weight=>62kg;
  2. 0.4ml, qod if weight between 38 and <62;
  3. 0.0075ml/kg, qod if weight between 27 and <38kg; study duration: 2 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women who are at least 18 years of age, and who have a diagnosis of advanced illness with anticipated life expectancy >= 1 month;
  • Is receiving a regular dose of opioids for the control of pain;
  • Has a diagnosis of opioid induced constipation;
  • Is on a stable laxative regimen.

Exclusion Criteria:

  • Has a known or suspected mechanical gastrointestinal obstruction, or any potential non-opioid cause of bowel dysfunction contributed to constipation;
  • Has evidence of current fecal impaction;
  • Has evidence of active diverticulitis, or peritonitis, or a history of bowel surgery within 30 days before test article administration;
  • Has a boy weight less t han 27 kg
  • Has any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study, or could preclude the evaluation of the subject's response.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936884

Locations
Korea, Republic of
Koyang-shi, Kyounggi-do, Korea, Republic of, 410-719
Seoul, Korea, Republic of, 137-701
Seoul, Korea, Republic of, 152-703
Seoul, Korea, Republic of, 135-710
Taiwan
Tainan, Taiwan, 70428
Taipei TOC, Taiwan, 100
Sponsors and Collaborators
Salix Pharmaceuticals
Progenics Pharmaceuticals, Inc.
Investigators
Study Director: Bob Rolleri, PhD Salix Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00936884     History of Changes
Other Study ID Numbers: 3200K1-3361, B2541004
Study First Received: July 8, 2009
Last Updated: November 7, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
Opioid Induced Constipation

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 21, 2014