Opioid-Induced ConstipationPhase 4NCT00858754
Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects
A Phase 4 study testing methylnaltrexone in people with Opioid-Induced Constipation, run by Bausch Health Americas, Inc. at 8 sites in 5 countries.
Trial summary
This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Opioid-Induced Constipation
- What is being tested?
- methylnaltrexone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Mar 2009to Aug 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is a man or woman aged 18 years or older.
- Has a body weight >= 38 kg.
- Has cancer (active or in remission), and has cancer-related pain (ie, pain due to cancer or treatment of cancer).
- Has a life expectancy of >= 6 months.
- Has a performance status of 0, 1, or 2 based on the Eastern Cooperative Oncology Group (ECOG) scale.
- Is taking opioids for cancer-related pain, and not just as-needed doses.
- Has a diagnosis of OIC as determined by the investigator.
- Is willing to follow the protocol instructions on laxative use during the study.
Who cannot join
- Has a history of chronic constipation before starting opioids.
- Has renal disease receiving dialysis.
- Has an ostomy for stools.
- Is a pregnant or breastfeeding woman.
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
United States4 sites
Pfizer Investigational Site
Flat Rock, North Carolina, 28731
Pfizer Investigational Site
Laguna Hills, California, 92637
Pfizer Investigational Site
Lancaster, California, 93534
Pfizer Investigational Site
Madison, Wisconsin, 53792
Location not given1 site
Pfizer Investigational Site
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain
This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.
- Conditions
- Opioid-Induced Constipation
- Being tested
- methylnaltrexone, placebo
- Keywords
- opioid induced constipation, Cancer patients, methylnaltrexone
- 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
placeboDrug
Also called Inactive
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Active Drug | Experimental | Methylnaltrexone Receives: Drug: methylnaltrexone |
| Group 2 Non-Active Drug | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments.
Measured: 1 Day
Secondary outcomes (1)
1. Bowel movements within 4 hours after at least 2 of the first 4 doses. 2. Bowel movements within 4 hours after all doses. 3. The time to bowel movement after the first dose.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Withdrawn \[This study was terminated early by Wyeth, prior to dosing any subjects, for business reasons not related to safety.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Progenics Pharmaceuticals, Inc.
- Investigators
- Jeff Cohn, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858754
- Sponsor's protocol ID
- 3200K1-4006
- Status last verified
- Nov 2019
- First submitted
- 9 Mar 2009
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain
- ClinicalTrials.gov ID
- NCT00858754
- Acronym / sponsor ID
- 3200K1-4006
- Conditions
- Opioid-Induced Constipation
- Keywords
- opioid induced constipation, Cancer patients, methylnaltrexone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn \[This study was terminated early by Wyeth, prior to dosing any subjects, for business reasons not related to safety.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Progenics Pharmaceuticals, Inc.
- Study start
- Mar 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 10 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Active Drug | Experimental | Drug: methylnaltrexoneMethylnaltrexone |
| Group 2 Non-Active Drug | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Is a man or woman aged 18 years or older.
- Has a body weight >= 38 kg.
- Has cancer (active or in remission), and has cancer-related pain (ie, pain due to cancer or treatment of cancer).
- Has a life expectancy of >= 6 months.
- Has a performance status of 0, 1, or 2 based on the Eastern Cooperative Oncology Group (ECOG) scale.
Key exclusion criteria (4 listed)
- Has a history of chronic constipation before starting opioids.
- Has renal disease receiving dialysis.
- Has an ostomy for stools.
- Is a pregnant or breastfeeding woman.
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 | Drug | Group 1 Active Drug |
| placeboAlso: Inactive | Drug | Group 2 Non-Active Drug |
Primary outcome
Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments.
Time frame: 1 Day
1 secondary outcome
1. Bowel movements within 4 hours after at least 2 of the first 4 doses. 2. Bowel movements within 4 hours after all doses. 3. The time to bowel movement after the first dose.
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Opioid-Induced Constipation
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Prevention of Opioid-induced Constipation in Patients With Advanced Cancer
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RecruitingObservational study
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Opioid-induced Constipation
RecruitingPhase 1/2
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
Opioid-Induced Constipation (OIC)
Not yet recruitingPhase 3
A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Trial
OIC
RecruitingObservational study
Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced CONstipation: Clinical Outcomes and Patient Experience
Cancer, Opioid Induced Constipation (OIC)
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.
Jeff Cohn study director
Bausch Health Americas, Inc.
8 sites in 5 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 8 sites in 5 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 8 inclusion and 4 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: withdrawn, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada, France, Spain. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments. (time frame: 1 Day). 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 29 Nov 2019.