Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain

This study has been completed.

Sponsor:

Collaborator:

Progenics Pharmaceuticals, Inc.

Information provided by:

Valeant Pharmaceuticals International, Inc.

ClinicalTrials.gov Identifier:

NCT00605644

First received: January 18, 2008

Last updated: July 22, 2011

Last verified: July 2011

History of Changes

Purpose

The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects administered MOA-728 who have chronic pain that is not due to cancer, and who have opioid-induced bowel dysfunction (OIBD).

Condition	Intervention	Phase
Constipation	Drug: MOA-728 Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Nonmalignant Pain

Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:

Spontaneous Bowel Movements [ Time Frame: App. 1 month ]


Enrollment:	120
Study Start Date:	January 2008
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo	Drug: Placebo Placebo
Experimental: 2 MOA-728	Drug: MOA-728 Oral Capsules
Experimental: 3 MOA-728	Drug: MOA-728 Oral Capsules
Experimental: 4 MOA-728	Drug: MOA-728 Oral Capsules
Experimental: 5 MOA-728	Drug: MOA-728 Oral Capsules

Eligibility


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

Criteria

Inclusion Criteria:

Adult Outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
Taking oral, transdermal, intravenous, or subcutaneous opioids.
Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

Exclusion Criteria:

History of chronic constipation before the initiation of opioid therapy.
Other GI disorders known to affect bowel transit.
Women who are pregnant, breast feeding, or plan to become pregnant.

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: NCT00605644

Sponsors and Collaborators

Valeant Pharmaceuticals International, Inc.

Progenics Pharmaceuticals, Inc.

Investigators


Study Director:	Jeff Cohn	Valeant Pharmaceuticals International, Inc.

More Information


Responsible Party:	Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00605644 History of Changes
Other Study ID Numbers:	3200A3-2202
Study First Received:	January 18, 2008
Last Updated:	July 22, 2011

Additional relevant MeSH terms:


Constipation Signs and Symptoms, Digestive Signs and Symptoms

ClinicalTrials.gov processed this record on September 21, 2017

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