Opioid-Induced ConstipationPhase 4NCT00672477
Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness
A Phase 4 study testing Methylnaltrexone in people with Opioid-Induced Constipation, run by Bausch Health Americas, Inc. at 60 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-Induced Constipation
- What is being tested?
- Methylnaltrexone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 237 participants
- Where
- 60 sitesin 12 countries
- Study dates
- Jun 2008to Feb 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
60 sites in 12 countries.
60 sites in 12 countries
United States29 sites
Salix Investigational Site
Albuquerque, New Mexico, 87108
Salix Investigational Site
American Fork, Utah, 84003
Salix Investigational Site
Auburndale, Florida, 33823
Salix Investigational Site
Aurora, Colorado, 80045
Salix Investigational Site
Austin, Texas, 78757
Salix Investigational Site
Cleveland, Ohio, 44119
Salix Investigational Site
Flat Rock, North Carolina, 28731
Salix Investigational Site
Houston, Texas, 77030
Salix Investigational Site
Hudson, Florida, 34667
Salix Investigational Site
Laguna Hills, California, 92637
Salix Investigational Site
Lakeland, Florida, 33805
Salix Investigational Site
Lakeland, Florida, 33815
Salix Investigational Site
Lancaster, California, 93534
Salix Investigational Site
Madison, Wisconsin, 53792
Salix Investigational Site
Miami Springs, Florida, 33166
Salix Investigational Site
Mobile, Alabama, 36604
Salix Investigational Site
Orange, New Jersey, 07018
Salix Investigational Site
Orem, Utah, 84058
Salix Investigational Site
Philadelphia, Pennsylvania, 19111
Salix Investigational Site
Provo, Utah, 84604
Salix Investigational Site
Ruskin, Florida, 33573
Salix Investigational Site
Salt Lake City, Utah, 84112
Salix Investigational Site
Sebring, Florida, 33870
Salix Investigational Site
Tampa, Florida, 33609
Salix Investigational Site
Tampa, Florida, 33612-9416
Salix Investigational Site
Tampa, Florida, 33619
Salix Investigational Site
Temple Terrace, Florida, 33617
Salix Investigational Site
West Palm Beach, Florida, 33407
Salix Investigational Site
Winston-Salem, North Carolina, 27103-5766
Canada6 sites
Salix Investigational Site
Edmonton, Alberta, T6G 1Z2
Salix Investigational Site
Hamilton, Ontario, L8M 1W9
Salix Investigational Site
Montreal, Quebec, H3A 1A1
Salix Investigational Site
Montreal, Quebec, H3T 1E2
Salix Investigational Site
Québec, Quebec, G1R 3S1
Salix Investigational Site
Winnipeg, Manitoba, R2H 2A6
France6 sites
Salix Investigational Site
Besançon, 25030
Salix Investigational Site
Bordeaux, 33075
Salix Investigational Site
Bordeaux, 33604
Salix Investigational Site
Grenoble, 38043
Salix Investigational Site
Montpellier, 34295
Salix Investigational Site
Villejuif, 94804
Australia3 sites
Salix Investigational Site
Coburg, Victoria, 3058
Salix Investigational Site
Darlinghurst, New South Wales, 2010
Salix Investigational Site
East Melbourne, Victoria, 3002
Germany3 sites
Salix Investigational Site
Aachen, 52074
Salix Investigational Site
Berlin, 14089
Salix Investigational Site
München, 80336
Italy3 sites
Salix Investigational Site
L’Aquila, 67100
Salix Investigational Site
Milan, 20020
Salix Investigational Site
Milan, 20133
Spain3 sites
Salix Investigational Site
Barcelona, 08036
Salix Investigational Site
L'Hospitalet de Llobregat, 8097
Salix Investigational Site
Seville, 41013
Brazil2 sites
Salix Investigational Site
Liberdade, São Paulo, 01509-900
Salix Investigational Site
São Paulo, São Paulo, 01508-010
Sweden2 sites
Salix Investigational Site
Kungsbacka, 434 80
Salix Investigational Site
Norrköping, 60185
United Kingdom1 site
Salix Investigational Site
Cheltenham, Gloucestershire, GL53 0Qj
About this study
Official 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
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.
- Conditions
- Opioid-Induced Constipation
- Being tested
- Methylnaltrexone, Placebo
- Keywords
- opioid-induced constipation
- Medical subject headings
- Opioid-Induced Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylnaltrexoneDrug
Also called MOA-728, Relistor
PlaceboDrug
Also called Control
| Study group | Role | What they receive |
|---|---|---|
| Methylnaltrexone | Experimental | 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. Receives: Drug: Methylnaltrexone |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses
This outcome measures the proportion of subjects who had a rescue-free laxation (ie, bowel movement) within 4 hours after at least 2 of the first 4 doses of study drug. A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.
Measured: 7 days
Secondary outcomes (1)
Time to First Rescue-free Laxation (Following the First Dose of Study Drug).
This outcome measures the time from first dose of study drug to the first rescue-free laxation (ie, bowel movement). A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid-Induced ConstipationStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Progenics Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Enoch Bortey, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672477
- Sponsor's protocol ID
- 3200K1-4000
- Other IDs
- B2541005
- Status last verified
- Feb 2018
- First submitted
- 2 May 2008
- Last updated
- 8 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Liao SS, Slatkin NE, Stambler N. The Influence of Age on Central Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation. Drugs Aging. 2021 Jun;38(6):503-511. doi: 10.1007/s40266-021-00850-w. Epub 2021 Mar 31.
PubMed 33788162Janku F, Johnson LK, Karp DD, Atkins JT, Singleton PA, Moss J. Treatment with methylnaltrexone is associated with increased survival in patients with advanced cancer. Ann Oncol. 2016 Nov;27(11):2032-2038. doi: 10.1093/annonc/mdw317. Epub 2016 Aug 29.
PubMed 27573565
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00672477
- Acronym / sponsor ID
- 3200K1-4000
- Conditions
- Opioid-Induced Constipation
- Keywords
- opioid-induced constipation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Progenics Pharmaceuticals, Inc.
- Study start
- Jun 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 6 May 2008 (estimated)
- Results
- Posted 8 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylnaltrexone | Experimental | Drug: MethylnaltrexoneMethylnaltrexone 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 | Placebo comparator | Drug: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylnaltrexoneAlso: MOA-728, Relistor | Drug | Methylnaltrexone |
| PlaceboAlso: Control | Drug | Placebo |
Primary outcome
The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses
Time frame: 7 days
This outcome measures the proportion of subjects who had a rescue-free laxation (ie, bowel movement) within 4 hours after at least 2 of the first 4 doses of study drug. A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.
1 secondary outcome
Time to First Rescue-free Laxation (Following the First Dose of Study Drug).
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33788162Liao SS, Slatkin NE, Stambler N. The Influence of Age on Central Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation. Drugs Aging. 2021 Jun;38(6):503-511. doi: 10.1007/s40266-021-00850-w. Epub 2021 Mar 31.
- Derived from this study: PubMed 27573565Janku F, Johnson LK, Karp DD, Atkins JT, Singleton PA, Moss J. Treatment with methylnaltrexone is associated with increased survival in patients with advanced cancer. Ann Oncol. 2016 Nov;27(11):2032-2038. doi: 10.1093/annonc/mdw317. Epub 2016 Aug 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enoch Bortey study director
Bausch Health Americas, Inc.
60 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylnaltrexone in people with Opioid-Induced Constipation, run by Bausch Health Americas, Inc. at 60 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Canada, France, Australia, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00672477, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2018.