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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00672477




Registration number
NCT00672477
Ethics application status
Date submitted
2/05/2008
Date registered
6/05/2008
Date last updated
8/03/2018

Titles & IDs
Public title
Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Study Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Adults With Advanced Illness And Opioid-Induced Constipation: Efficacy, Safety, And Additional Health Outcomes
Secondary ID [1] 0 0
B2541005
Secondary ID [2] 0 0
3200K1-4000
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid-Induced 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 - Methylnaltrexone
Treatment: Drugs - Placebo

Experimental: Methylnaltrexone - Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL (12 mg) every other day if weight = 62kg; or 0.4 mL (8 mg) every other day if weight between 38 and <62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information.

Placebo Comparator: Placebo - Placebo subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL every other day if weight = 62kg; or 0.4 mL every other day if weight between 38 and < 62 kg. Subjects with impaired kidney function received reduced volumes of placebo solution to match the volumes used in the experimental group.


Treatment: Drugs: Methylnaltrexone


Treatment: Drugs: Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses
Timepoint [1] 0 0
7 days
Secondary outcome [1] 0 0
Time to First Rescue-free Laxation (Following the First Dose of Study Drug).
Timepoint [1] 0 0
14 days

Eligibility
Key inclusion criteria
- Is an adult 18 years of age or older

- Has a diagnosis of advanced illness (ie, a terminal illness such as incurable cancer
or other end-stage disease)

- Has a life expectancy of at least 1 month.

- Is receiving opioids on a regular schedule (not just as-needed or rescue doses) for
the control of pain or discomfort for at least 2 weeks before the first dose of study
drug.

- Has constipation that is caused by opioid medications.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has a known or suspected allergy to methylnaltrexone or other similar compounds (e.g.
naltrexone or naloxone).

- Has a known or suspected mechanical gastrointestinal obstruction.

- Has any potential nonopioid cause of bowel dysfunction that might be a major
contributor to the constipation.

- Has any other clinically important abnormalities as determined by the investigator
that may interfere with his or her participation in or compliance with the study.

- Receiving opioid antagonist or partial antagonist products.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
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
1/06/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2013
Sample size
Target
Accrual to date
Final
237
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Salix Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
Salix Investigational Site - Coburg
Recruitment hospital [3] 0 0
Salix Investigational Site - East Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3058 - Coburg
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
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Utah
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United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Brazil
State/province [14] 0 0
Sao Paulo
Country [15] 0 0
Brazil
State/province [15] 0 0
SP
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
Canada
State/province [17] 0 0
Manitoba
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
France
State/province [20] 0 0
Besancon
Country [21] 0 0
France
State/province [21] 0 0
Bordeaux
Country [22] 0 0
France
State/province [22] 0 0
Grenoble
Country [23] 0 0
France
State/province [23] 0 0
Montpellier
Country [24] 0 0
France
State/province [24] 0 0
Villejuif
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Germany
State/province [25] 0 0
Aachen
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Germany
State/province [26] 0 0
Berlin
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Germany
State/province [27] 0 0
Muenchen
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Italy
State/province [28] 0 0
L'Aquila
Country [29] 0 0
Italy
State/province [29] 0 0
Milano
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Italy
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Milan
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Mexico
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Mexico City DF
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Spain
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Barcelona
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Spain
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L'Hospitalet De Llobregat
Country [34] 0 0
Spain
State/province [34] 0 0
Sevilla
Country [35] 0 0
Sweden
State/province [35] 0 0
Kungsbacka
Country [36] 0 0
Sweden
State/province [36] 0 0
Norrköping
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Gloucestershire

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
Progenics Pharmaceuticals, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the safety and efficacy of methylnaltrexone administered as
subcutaneous injections in subjects who have opioid-induced constipation and an advanced
illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving
opioid-induced constipation in these subjects.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00672477
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Enoch Bortey
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00672477