Study Evaluating Long-Term Safety of MOA-728 in Subjects With Opioid-Induced Constipation - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00804141

Purpose

This is a one-year study to evaluate the long-term safety and tolerability of the subcutaneous (just under the skin) injection form of MOA-728 for the treatment of opioid-induced constipation in subjects with nonmalignant pain. The study consists of a 2 week screening period, a 48 week open-label treatment period and a 2 week follow-up period. Subjects will need to agree to self-administer subcutaneous injections, complete daily diaries, and check-in via a daily telephone call during that year-long period.

Condition	Intervention	Phase
Constipation	Drug: N-methylnaltrexone bromide (MOA-728)	Phase III

MedlinePlus related topics: Constipation

Drug Information available for: Methylnaltrexone Methylnaltrexone bromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
Official Title:	An Open-Label Study to Evaluate the Long-Term Safety of Subcutaneous MOA-728 for Treatment of Opioid-Induced Constipation in Subjects With Nonmalignant Pain

Further study details as provided by Wyeth:

Primary Outcome Measures:

collection of safety data & assessments to include monitoring of treatment emergent adverse events, safety laboratory measurements, electrocardiograms and changes in the physical exam including vital signs while on therapy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

change in bowel function compared to baseline [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	800
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental open-label	Drug: N-methylnaltrexone bromide (MOA-728)

Eligibility

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

Criteria

Inclusion criteria:

Men and women 18 years or older,
History of pain of at least 2 months duration before study entry due to documented underlying nonmalignant condition,
History of constipation due to opioid use for the nonmalignant condition,

Exclusion criteria:

Diagnosis of significant GI disorder such as bowel obstruction, fecal incontinence or rectal prolapse for example,
History of active inflammatory bowel disease, irritable bowel syndrome, or megacolon within 6 months before study entry,
History of malignancy or chronic constipation before initiation of opioid therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804141

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

United States, Florida
	Recruiting
Winter Park, Florida, United States, 32789
Contact: trial manager clintrialparticipation@wyeth.com
	Recruiting
Brandon, Florida, United States, 33511
Contact: trial manager clintrialparticipation@wyeth.com
	Recruiting
Chiefland, Florida, United States, 32626
	Recruiting
Jacksonville, Florida, United States, 32216
	Recruiting
Sarasota, Florida, United States, 34239
	Recruiting
Tampa, Florida, United States, 33603
	Recruiting
Ocala, Florida, United States, 34471
	Recruiting
Ormond Beach, Florida, United States, 32174
United States, Indiana
	Recruiting
Avon, Indiana, United States, 46123
United States, North Carolina
	Recruiting
Charlotte, North Carolina, United States, 28024
United States, Pennsylvania
	Recruiting
Levittown, Pennsylvania, United States, 19056-2404

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3200K1-3358
Study First Received:	December 5, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00804141
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

treatment for opioid-induced constipation

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Bromides
Naltrexone

Constipation
Methylnaltrexone
Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Narcotic Antagonists

Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009