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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00804141




Registration number
NCT00804141
Ethics application status
Date submitted
5/12/2008
Date registered
8/12/2008
Date last updated
18/10/2019

Titles & IDs
Public title
Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation
Scientific 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
Secondary ID [1] 0 0
3200K1-3358
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Constipation 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - N-methylnaltrexone bromide (MOA-728)

Experimental: MOA-728 12 mg QD - Participants will receive MOA-728 12 milligrams (mg) SC once daily (QD) for 48 weeks. Dosing could be adjusted to an as needed (PRN) basis with a minimum 1 dose per week and maximum 1 dose per day.


Treatment: Drugs: N-methylnaltrexone bromide (MOA-728)
MOA-728 will be administered as per the dose and schedule specified in the arm.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Baseline up to Week 50
Secondary outcome [1] 0 0
Change From Baseline in Weekly Bowel Movement (BM) Rate Through Follow-up
Timepoint [1] 0 0
Baseline, follow-up (14 days [Week 49 to 50])

Eligibility
Key inclusion criteria
* Men and women 18 years or older.
* A history of pain of at least 2 months duration before the screening visit due to documented underlying nonmalignant condition.
* A history of constipation due to opioid use during 1 month before the screening visit.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* A diagnosis of significant gastrointestinal (GI) disorder such as bowel obstruction, fecal incontinence or rectal prolapse.
* A history of active inflammatory bowel disease, irritable bowel syndrome, or megacolon within 6 months before the screening visit.
* A history of malignancy, other than basal cell or squamous cell skin carcinoma, within 5 years before the screening visit.
* A history of chronic constipation before initiation of opioid therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/09/2010
Sample size
Target
Accrual to date
Final
1040
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Broadmeadow
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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Florida
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Illinois
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Indiana
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Iowa
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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Tennessee
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Texas
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Utah
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Virginia
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United States of America
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Washington
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Newfoundland and Labrador
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Colombia
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Atlantico
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Colombia
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Cundinamarca
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Seoul/Korea
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Korea, Republic of
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Seoul
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Spain
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Barcelona/Spain
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Spain
State/province [47] 0 0
Madrid/Spain

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bausch Health Americas, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lindsey Mathew
Address 0 0
Bausch Health Americas, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Michna E, Blonsky ER, Schulman S, Tzanis E, Manley... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00804141