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

Sponsor:	Pfizer
Information provided by:	Pfizer
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

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Constipation

Drug Information available for: Methylnaltrexone bromide Methylnaltrexone

U.S. FDA Resources

Further study details as provided by Pfizer:

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 ]

Enrollment:	1040
Study Start Date:	December 2008
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 open-label	Drug: N-methylnaltrexone bromide (MOA-728) 48 week treatment with 12 mg MOA-728 administered subcutaneously at least once per week with a maximum frequency of once daily. Other Name: Relistor

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

Show 120 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT00804141 History of Changes
Other Study ID Numbers:	3200K1-3358
Study First Received:	December 5, 2008
Last Updated:	June 3, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

treatment for opioid-induced constipation

Additional relevant MeSH terms:

Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Methylnaltrexone
Naltrexone
Analgesics, Opioid
Narcotic Antagonists
Physiological Effects of Drugs

Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on February 09, 2012