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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00936884
Recruitment Status : Completed
First Posted : July 10, 2009
Last Update Posted : November 8, 2013
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Constipation Drug: MOA728 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
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
Study Start Date : July 2009
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Percentage of injection resulting in RFBM within 4 hours after test article administration. [ Time Frame: 2 weeks ]

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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.

Additional Information:
Responsible Party: Valeant Pharmaceuticals International, Inc. Identifier: NCT00936884     History of Changes
Other Study ID Numbers: 3200K1-3361
First Posted: July 10, 2009    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: November 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