Terminal IllnessPhase 3NCT01367613
Open-Label Treatment Extension of Protocol MNTX 302
A Phase 3 study testing SC Methylnaltrexone in people with Terminal Illness, run by Bausch Health Americas, Inc. at 1 site in United States.
Trial summary
This is a 3 month open-label extension study that allows patients who completed Protocol MNTX 302 to receive SC MNTX. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Terminal Illness
- What is being tested?
- SC Methylnaltrexone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jan 2006
- 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
- Must be enrolled and consented within 28 days of the end of study visit of MNTX 302 and 14 or more days from first dose of study drug in MNTX 302.
- Negative pregnancy test
- Stable vital signs
Who cannot join
- Women who are pregnant and/or nursing
- Received any investigational product, other than MNTX, in the past 30 days
- Evidence of fecal impaction
- Clinically significant active diverticular disease
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 Three-Month Open-Label Treatment Extension of Protocol MNTX 302
This is a 3 month open-label extension study that allows patients who completed Protocol MNTX 302 to receive SC MNTX.
- Conditions
- Terminal Illness
- Being tested
- SC Methylnaltrexone
- Keywords
- Advanced medical illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC MethylnaltrexoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: SC Methylnaltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
To provide access to treatment with MNTX, administered SC, to patients who completed Progenics' Protocol MNTX 302
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startMar 2004
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Terminal IllnessStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tage Ramakrishna, MD, Study director, Progenics Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367613
- Sponsor's protocol ID
- MNTX 302EXT
- Status last verified
- Nov 2019
- First submitted
- 27 May 2011
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Month Open-Label Treatment Extension of Protocol MNTX 302
- ClinicalTrials.gov ID
- NCT01367613
- Acronym / sponsor ID
- MNTX 302EXT
- Conditions
- Terminal Illness
- Keywords
- Advanced medical illness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 7 Jun 2011 (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 is a 3 month open-label extension study that allows patients who completed Protocol MNTX 302 to receive SC MNTX.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: SC Methylnaltrexone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be enrolled and consented within 28 days of the end of study visit of MNTX 302 and 14 or more days from first dose of study drug in MNTX 302.
- Negative pregnancy test
- Stable vital signs
Key exclusion criteria (4 listed)
- Women who are pregnant and/or nursing
- Received any investigational product, other than MNTX, in the past 30 days
- Evidence of fecal impaction
- Clinically significant active diverticular disease
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 Methylnaltrexone | Drug | Arm 1 |
Primary outcome
Number of patients with adverse events
Time frame: 3 months
To provide access to treatment with MNTX, administered SC, to patients who completed Progenics' Protocol MNTX 302
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 27 Nov 2019.
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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.
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 Terminal Illness, 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 3 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: finished, as of the sponsor's last update on 27 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. 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?
Number of patients with adverse events (time frame: 3 months). 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 27 Nov 2019.