Opioid-Induced ConstipationPhase 4NCT00672139
Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness
A Phase 4 study testing Methylnaltrexone bromide in people with Opioid-Induced Constipation, run by Bausch Health Americas, Inc. at 46 sites in 10 countries.
Trial summary
This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. 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 bromide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 46 sitesin 10 countries
- Study dates
- Jul 2008to May 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
- Has completed study 3200K1-4000-WW, including 2 weeks of therapy and completion of all post baseline efficacy, safety, and health outcomes assessments.
- Is receiving opioids on a regular schedule, not just as needed to control pain.
- Likely to continue to need treatment of OIC for the duration of participation in the study.
Who cannot join
- Has a suspected mechanical gastrointestinal obstruction, fecal impaction, or clinically important active diverticular disease as determined by the investigator.
- Currently using an opioid antagonist or partial antagonist.
- Has any other clinically important abnormalities such that risk to patient of participation outweighs the potential benefit of therapy as determined by the investigator
Trial locations and contacts
46 sites in 10 countries.
46 sites in 10 countries
United States26 sites
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
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
Winston-Salem, North Carolina, 27103-5766
Canada6 sites
Salix Investigational Site
Edmonton, Alberta, T6G 1Z2
Salix Investigational Site
Edmonton, Alberta, T6L 5X8
Salix Investigational Site
Hamilton, Ontario, L8M 1W9
Salix Investigational Site
London, Ontario, N6A 4L6
Salix Investigational Site
Montreal, Quebec, H3A 1A1
Salix Investigational Site
Québec, Quebec, G1R 3S1
Italy4 sites
Salix Investigational Site
L’Aquila, 67100
Salix Investigational Site
Milan, 20020
Salix Investigational Site
Milan, 20133
Salix Investigational Site
Roma, 00144
Australia3 sites
Salix Investigational Site
Adelaide, 5000
Salix Investigational Site
Coburg, Victoria, 3058
Salix Investigational Site
East Melbourne, Victoria, 3002
Portugal2 sites
Salix Investigational Site
Almada, 2801-951
Salix Investigational Site
Porto, 4200-072
United Kingdom1 site
Salix Investigational Site
Cheltenham, Gloucestershire, GL53 0QJ
About this study
Official title: Open-Label Extension Study To Assess The Safety Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Subjects With Advanced Illness And Opioid-Induced Constipation
This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.
- Conditions
- Opioid-Induced Constipation
- Being tested
- Methylnaltrexone bromide
- 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.
Methylnaltrexone bromideDrug
Also called Relistor
| Study group | Role | What they receive |
|---|---|---|
| Methylnaltrexone bromide | Experimental | Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.
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 bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Laxations Per Subject Within 24 Hours of Dosing Per Week.
This was defined as the total number of days with a laxation (ie, a bowel movement) within 24 hours after dosing in each 7-day interval after the start of dosing. Results shown are the ranges (lowest and highest weekly values) of mean (± standard deviation) numbers of laxations within 24 hours of dosing per week during the 10-week treatment period for each group.
Measured: 10 weeks
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 startJul 2008
- Primary completionJan 2013
- Study completionMay 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 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
- NCT00672139
- Sponsor's protocol ID
- 3200K1-4001
- Other IDs
- B2541006
- Status last verified
- Feb 2018
- First submitted
- 2 May 2008
- Last updated
- 7 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Extension Study To Assess The Safety Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Subjects With Advanced Illness And Opioid-Induced Constipation
- ClinicalTrials.gov ID
- NCT00672139
- Acronym / sponsor ID
- 3200K1-4001
- Conditions
- Opioid-Induced Constipation
- Keywords
- Opioid-Induced Constipation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Progenics Pharmaceuticals, Inc.
- Study start
- Jul 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 6 May 2008 (estimated)
- Results
- Posted 7 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 is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methylnaltrexone bromide | Experimental | Drug: Methylnaltrexone bromideMethylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has completed study 3200K1-4000-WW, including 2 weeks of therapy and completion of all post baseline efficacy, safety, and health outcomes assessments.
- Is receiving opioids on a regular schedule, not just as needed to control pain.
- Likely to continue to need treatment of OIC for the duration of participation in the study.
Key exclusion criteria (3 listed)
- Has a suspected mechanical gastrointestinal obstruction, fecal impaction, or clinically important active diverticular disease as determined by the investigator.
- Currently using an opioid antagonist or partial antagonist.
- Has any other clinically important abnormalities such that risk to patient of participation outweighs the potential benefit of therapy as determined by the investigator
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 |
|---|---|---|
| Methylnaltrexone bromideAlso: Relistor | Drug | Methylnaltrexone bromide |
Primary outcome
Number of Laxations Per Subject Within 24 Hours of Dosing Per Week.
Time frame: 10 weeks
This was defined as the total number of days with a laxation (ie, a bowel movement) within 24 hours after dosing in each 7-day interval after the start of dosing. Results shown are the ranges (lowest and highest weekly values) of mean (± standard deviation) numbers of laxations within 24 hours of dosing per week during the 10-week treatment period for each group.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
46 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylnaltrexone bromide in people with Opioid-Induced Constipation, run by Bausch Health Americas, Inc. at 46 sites in 10 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 3 inclusion and 3 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 7 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 46 sites in United States, Canada, Italy, Australia, Portugal and 5 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. 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 7 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?
Number of Laxations Per Subject Within 24 Hours of Dosing Per Week. (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2018.