Advance Illness Patients With OICPhase 3NCT00402038
Study of Methylnaltrexone (MNTX) for the Relief of Constipation
A Phase 3 study testing SC Methylnaltrexone in people with Advance Illness Patients With OIC, run by Bausch Health Americas, Inc. at 1 site in United States.
Trial summary
To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advance Illness Patients With OIC
- What is being tested?
- SC Methylnaltrexone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Oct 2005
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- Negative pregnancy test (serum or urine) at screening for all women of childbearing potential
- Advanced Medical Illness (i.e., terminal illness, such as incurable cancer or end of stage AIDS) with life expectancy of ≥ 1 month
- patient must sign ICF
Who cannot join
- Women who are pregnant and/or nursing
- Previous treatment with MNTX
- Participation in any other studies involving investigational products within 30 days prior to screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Progenics Pharmaceuticals, Inc.
Tarrytown, New York, 10591
About this study
Official title: A Double-Blind, Phase 3, Two-Week, Placebo Controlled Study of Methylnaltrexone(MNTX) for the Relief of Constipation Due to Opioid Therapy in Advance Medical Illness.
To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.
Read the detailed description
This is a multi-center, double-blind, randomized parallel group study conducted in patients with advanced medical illness and opioid-induced constipation. Eligible patients are randomly assigned to receive SC doses of either MNTX, dose 1 or placebo every other day for 2 weeks. At Day 8, eligible patients, if allowed, could be escalated to a a higher dose of MNTX.
- Conditions
- Advance Illness Patients With OIC
- Being tested
- SC Methylnaltrexone, SC Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC MethylnaltrexoneDrug
Dose 1
SC PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: SC Methylnaltrexone |
| Arm 2 | Placebo comparator | Not described Receives: Drug: SC Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laxation within four hours of a single dose of SC MNTX and efficacy of SC MNTX every other day over a 1 week period.
To determine the efficacy of a single dose of SC MNTX compared with placebo in inducing laxation within 4 hours.
To determine the efficacy of SC MNTX every other day over a 1-week treatment period in relieving OIC in patients with AMI.
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 posted22 Nov 2006 (estimated)
- Study startFeb 2004
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Advance Illness Patients With OICStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Investigators
- Tage Ramakrishna, MD, Study director, Progenics Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402038
- Sponsor's protocol ID
- MNTX 302
- Status last verified
- Nov 2019
- First submitted
- 17 Nov 2006
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
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 33788162Chamberlain BH, Rhiner M, Slatkin NE, Stambler N, Israel RJ. Subcutaneous methylnaltrexone for opioid-induced constipation in advanced-illness patients with or without active cancer. Pain Manag. 2020 Mar;10(2):73-84. doi: 10.2217/pmt-2019-0045. Epub 2020 Jan 17.
PubMed 31951150Nalamachu SR, Pergolizzi J, Taylor R Jr, Slatkin NE, Barrett AC, Yu J, Bortey E, Paterson C, Forbes WP. Efficacy and Tolerability of Subcutaneous Methylnaltrexone in Patients with Advanced Illness and Opioid-Induced Constipation: A Responder Analysis of 2 Randomized, Placebo-Controlled Trials. Pain Pract. 2015 Jul;15(6):564-71. doi: 10.1111/papr.12218. Epub 2014 May 10.
PubMed 24815199Lipman AG, Karver S, Cooney GA, Stambler N, Israel RJ. Methylnaltrexone for opioid-induced constipation in patients with advanced illness: a 3-month open-label treatment extension study. J Pain Palliat Care Pharmacother. 2011;25(2):136-45. doi: 10.3109/15360288.2011.573531.
PubMed 21657861Thomas J, Karver S, Cooney GA, Chamberlain BH, Watt CK, Slatkin NE, Stambler N, Kremer AB, Israel RJ. Methylnaltrexone for opioid-induced constipation in advanced illness. N Engl J Med. 2008 May 29;358(22):2332-43. doi: 10.1056/NEJMoa0707377.
PubMed 18509120
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Phase 3, Two-Week, Placebo Controlled Study of Methylnaltrexone(MNTX) for the Relief of Constipation Due to Opioid Therapy in Advance Medical Illness.
- ClinicalTrials.gov ID
- NCT00402038
- Acronym / sponsor ID
- MNTX 302
- Conditions
- Advance Illness Patients With OIC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Feb 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 22 Nov 2006 (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.
To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.
Detailed description
This is a multi-center, double-blind, randomized parallel group study conducted in patients with advanced medical illness and opioid-induced constipation. Eligible patients are randomly assigned to receive SC doses of either MNTX, dose 1 or placebo every other day for 2 weeks. At Day 8, eligible patients, if allowed, could be escalated to a a higher dose of MNTX.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: SC Methylnaltrexone |
| Arm 2 | Placebo comparator | Drug: SC Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age and older
- Negative pregnancy test (serum or urine) at screening for all women of childbearing potential
- Advanced Medical Illness (i.e., terminal illness, such as incurable cancer or end of stage AIDS) with life expectancy of ≥ 1 month
- patient must sign ICF
Key exclusion criteria (3 listed)
- Women who are pregnant and/or nursing
- Previous treatment with MNTX
- Participation in any other studies involving investigational products within 30 days prior to screening
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 |
|---|---|---|
| SC MethylnaltrexoneDose 1 | Drug | Arm 1 |
| SC Placebo | Drug | Arm 2 |
Primary outcome
Laxation within four hours of a single dose of SC MNTX and efficacy of SC MNTX every other day over a 1 week period.
Time frame: 2 weeks
To determine the efficacy of a single dose of SC MNTX compared with placebo in inducing laxation within 4 hours. To determine the efficacy of SC MNTX every other day over a 1-week treatment period in relieving OIC in patients with AMI.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- 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 31951150Chamberlain BH, Rhiner M, Slatkin NE, Stambler N, Israel RJ. Subcutaneous methylnaltrexone for opioid-induced constipation in advanced-illness patients with or without active cancer. Pain Manag. 2020 Mar;10(2):73-84. doi: 10.2217/pmt-2019-0045. Epub 2020 Jan 17.
- Derived from this study: PubMed 24815199Nalamachu SR, Pergolizzi J, Taylor R Jr, Slatkin NE, Barrett AC, Yu J, Bortey E, Paterson C, Forbes WP. Efficacy and Tolerability of Subcutaneous Methylnaltrexone in Patients with Advanced Illness and Opioid-Induced Constipation: A Responder Analysis of 2 Randomized, Placebo-Controlled Trials. Pain Pract. 2015 Jul;15(6):564-71. doi: 10.1111/papr.12218. Epub 2014 May 10.
- Derived from this study: PubMed 21657861Lipman AG, Karver S, Cooney GA, Stambler N, Israel RJ. Methylnaltrexone for opioid-induced constipation in patients with advanced illness: a 3-month open-label treatment extension study. J Pain Palliat Care Pharmacother. 2011;25(2):136-45. doi: 10.3109/15360288.2011.573531.
- Derived from this study: PubMed 18509120Thomas J, Karver S, Cooney GA, Chamberlain BH, Watt CK, Slatkin NE, Stambler N, Kremer AB, Israel RJ. Methylnaltrexone for opioid-induced constipation in advanced illness. N Engl J Med. 2008 May 29;358(22):2332-43. doi: 10.1056/NEJMoa0707377.
- Related InfoLink provided by the sponsor.
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.
Tage Ramakrishna, MD study director
Progenics Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SC Methylnaltrexone in people with Advance Illness Patients With OIC, run by Bausch Health Americas, Inc. at 1 site in United States.
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 4 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 25 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 1 site in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Laxation within four hours of a single dose of SC MNTX and efficacy of SC MNTX every other day over a 1 week period. (time frame: 2 weeks). 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 NCT00402038, which also lists 5 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 25 Nov 2019.