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

This study has been completed.
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc. Identifier:
First received: July 8, 2009
Last updated: November 7, 2013
Last verified: November 2013
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Valeant Pharmaceuticals International, Inc.:

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 ]

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

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
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00936884

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

Additional Information:
Responsible Party: Valeant Pharmaceuticals International, Inc. Identifier: NCT00936884     History of Changes
Other Study ID Numbers: 3200K1-3361
Study First Received: July 8, 2009
Last Updated: November 7, 2013

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Opioid Induced Constipation

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on August 18, 2017