Postoperative IleusPhase 2NCT01367548
Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus
A Phase 2 study testing IV Methylnaltrexone (MNTX) in people with Postoperative Ileus, run by Bausch Health Americas, Inc. at 1 site in United States.
Trial summary
A double-blind, randomized, parallel-group study designed to evaluate the safety and activity of IV MNTX in the treatment of Post-Operative Ileus (POI) in patients who underwent segmental colectomies via laparotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- IV Methylnaltrexone (MNTX)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Dec 2004
- Phase
- Phase 2
- 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
- Males and females, 18 yrs or older
- Patients who have undergone a segmental colectomy
- Must be receiving opioids via IV.
Who cannot join
- Patients who received any experimental drug in the last 30 days
- Patients receiving spinal medication for post-operative pain relief
- Patients who have undergone operations for complications related to inflammatory bowel disease
- Patients with recent history of abdominal radiation therapy.
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 Phase II Double-Blind Randomized Parallel Group Study of Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus
A double-blind, randomized, parallel-group study designed to evaluate the safety and activity of IV MNTX in the treatment of Post-Operative Ileus (POI) in patients who underwent segmental colectomies via laparotomy.
- Conditions
- Postoperative Ileus
- Being tested
- IV Methylnaltrexone (MNTX), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Methylnaltrexone (MNTX)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: IV Methylnaltrexone (MNTX) |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to tolerance of liquids
To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.
Measured: 7 days
Secondary outcomes (4)
Time to first bowel movement
To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.
Measured: 7 days
Time to tolerance of solid foods
To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.
Measured: 7 days
Time to first micturition post foley catheter removal
To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.
Measured: 7 days
Time to hospital discharge
To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.
Measured: 7 days
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 startJul 2003
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 65 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
- NCT01367548
- Sponsor's protocol ID
- MNTX 203
- Status last verified
- Nov 2019
- First submitted
- 27 May 2011
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
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 Phase II Double-Blind Randomized Parallel Group Study of Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus
- ClinicalTrials.gov ID
- NCT01367548
- Acronym / sponsor ID
- MNTX 203
- Conditions
- Postoperative Ileus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (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.
A double-blind, randomized, parallel-group study designed to evaluate the safety and activity of IV MNTX in the treatment of Post-Operative Ileus (POI) in patients who underwent segmental colectomies via laparotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: IV Methylnaltrexone (MNTX) |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females, 18 yrs or older
- Patients who have undergone a segmental colectomy
- Must be receiving opioids via IV.
Key exclusion criteria (4 listed)
- Patients who received any experimental drug in the last 30 days
- Patients receiving spinal medication for post-operative pain relief
- Patients who have undergone operations for complications related to inflammatory bowel disease
- Patients with recent history of abdominal radiation therapy.
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 |
|---|---|---|
| IV Methylnaltrexone (MNTX) | Drug | Arm 1 |
| Placebo | Drug | Arm 2 |
Primary outcome
Time to tolerance of liquids
Time frame: 7 days
To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.
4 secondary outcomes
Time to first bowel movement
Time frame: 7 days
Time to tolerance of solid foods
Time frame: 7 days
Time to first micturition post foley catheter removal
Time frame: 7 days
Time to hospital discharge
Time frame: 7 days
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.
Related trials for Postoperative Ileus
Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
At-Home Bowel Stimulation
Post-Operative Ileus (POI)
Recruiting
The Food Network Effect
Post Operative Patients
RecruitingPhase 4
Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery
Pain, Postoperative, Postoperative Ileus
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 2 study testing IV Methylnaltrexone (MNTX) in people with Postoperative Ileus, 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Time to tolerance of liquids (time frame: 7 days). 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.