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Trial details imported from ClinicalTrials.gov

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

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) - Adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Serious adverse events (SAEs) included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as an AE that emerged during the treatment period. Any TEAEs included both treatment-emergent SAEs and non-serious AEs. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
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 - Weekly BM rate was derived as the total number of BMs reported in a month divided by the total number of days with non-missing BM diary information in the same month, then multiplied by 7 to normalize to a weekly rate. If the total number of days with non-missing BM diary information in a given month was less than 10 days, the weekly BM rate for the month was defined as missing. The weekly BM rate at baseline was calculated based on the screening period (Days -14 to -1). If the total number of days with non-missing BM diary information during the screening period was less than 5 days, the weekly BM rate at baseline was defined as missing.
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
Gender
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
N/A
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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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
This study is designed to evaluate the long-term safety and tolerability of the subcutaneous
(SC) injection form of N-methylnaltrexone bromide (MOA-728) for the treatment of
opioid-induced constipation in participants 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.
Participants will need to agree to self-administer SC injections, complete daily diaries, and
check-in via a daily telephone call during the study.
Trial website
https://clinicaltrials.gov/show/NCT00804141
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

Summary results
Other publications