ConstipationPhase 4NCT01773096
Methylnaltrexone Use for Opioid-induced Postoperative Constipation
A Phase 4 study testing Methylnaltrexone and Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax in people with Constipation, run by Shriners Hospitals for Children at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the routine use of methylnaltrexone in the post-operative pediatric spinal fusion patient will decrease the incidence of constipation. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Constipation
- What is being tested?
- Methylnaltrexone and Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to May 2015
- 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 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- spinal fusion surgery
- current opioid use
- 12 years of age and older
- no or inadequate bowel movement by post-operative day 3
Who cannot join
- known or expected mechanical bowel obstruction
- known or suspected lesions of the GI tract
- unexpected transfer to ICU
- unexpected return to the operating room
- patient or parent refusal of methylnaltrexone
- incomplete data concerning time to laxation
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children- Spokane
Spokane, Washington, 99203
About this study
Official title: The Use of Methylnaltrexone to Reduce Post-operative Opioid-induced Constipation in the Pediatric Spinal Fusion Patient
The purpose of this study is to determine whether the routine use of methylnaltrexone in the post-operative pediatric spinal fusion patient will decrease the incidence of constipation.
Read the detailed description
Methylnaltrexone will be given to pediatric patients post-operative from spinal fusion surgery on post-operative day number 3 and then again on postoperative day number 4, if no laxation achieved. Various outcome measures, safety and efficacy of the drug will be observed and recorded.
- Conditions
- Constipation
- Being tested
- Methylnaltrexone, Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax
- Keywords
- opioid-induced
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylnaltrexoneDrug
Also called Relistor
Patient will receive methylnaltrexone on postoperative day 3 on a weight based dose and again 24 hours later if required.
Senna, docusate sodium, bisacodyl, magnesium hydroxide, MiralaxDrug
Also called Senokot,Colace, Dulcolax, Milk of Magnesia, polyethylene glycol
Standard institutional bowel protocol will begin on post-operative day 1. Miralax,Docusate sodium or senna will be given on a weight-based dosing. If no bowel movement in 72 hours, bisacodyl or magnesium hydroxide will be added.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Weight-based dose (0.15 mg/kg for patients less than 38 kg, 8 mg for patients weighing 38-62 kg, or 12 mg for patients weighing greater than 62 kg) of methylnaltrexone will be administered on post-operative day 3 and again, if indicated, on post-operative day 4. This group will also receive the standard bowel protocol beginning on postoperative day one as per protocol. Receives: Drug: Methylnaltrexone; Drug: Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax |
| Institutional bowel protocol | Active comparator | Patient will receive institutional standard bowel protocol. Beginning on post-operative day one either miralx,docusate sodium or senna, on a weight-based dose. If no bowel movement in 72 hours, either oral bisacodyl or magnesium hydroxide, on a weight-based dosing, will be added. Receives: Drug: Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of post-operative opioid induced constipation
Measured: first post-operative week
Secondary outcomes (1)
time to ambulation in post-operative pediatric spinal fusion patients
Measured: first post-operative week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah J. Vermaire MD, Shriners Hospitals for Children
- Investigators
- Deborah J. Vermaire, M.D., Principal investigator, Shriners Hospitals for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773096
- Sponsor's protocol ID
- MNTX-2013
- Status last verified
- May 2015
- First submitted
- 15 Jan 2013
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Anissian L, Schwartz HW, Vincent K, Vincent HK, Carpenito J, Stambler N, Ramakrishna T. Subcutaneous methylnaltrexone for treatment of acute opioid-induced constipation: phase 2 study in rehabilitation after orthopedic surgery. J Hosp Med. 2012 Feb;7(2):67-72. doi: 10.1002/jhm.943. Epub 2011 Oct 13.
PubMed 21998076
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Methylnaltrexone to Reduce Post-operative Opioid-induced Constipation in the Pediatric Spinal Fusion Patient
- ClinicalTrials.gov ID
- NCT01773096
- Acronym / sponsor ID
- MNTX-2013
- Conditions
- Constipation
- Keywords
- opioid-induced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 23 Jan 2013 (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.
The purpose of this study is to determine whether the routine use of methylnaltrexone in the post-operative pediatric spinal fusion patient will decrease the incidence of constipation.
Detailed description
Methylnaltrexone will be given to pediatric patients post-operative from spinal fusion surgery on post-operative day number 3 and then again on postoperative day number 4, if no laxation achieved. Various outcome measures, safety and efficacy of the drug will be observed and recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Methylnaltrexone, Drug: Senna, docusate sodium, bisacodyl, magnesium hydroxide, MiralaxWeight-based dose (0.15 mg/kg for patients less than 38 kg, 8 mg for patients weighing 38-62 kg, or 12 mg for patients weighing greater than 62 kg) of methylnaltrexone will be administered on post-operative day 3 and again, if indicated, on post-operative day 4. This group will also receive the standard bowel protocol beginning on postoperative day one as per protocol. |
| Institutional bowel protocol | Active comparator | Drug: Senna, docusate sodium, bisacodyl, magnesium hydroxide, MiralaxPatient will receive institutional standard bowel protocol. Beginning on post-operative day one either miralx,docusate sodium or senna, on a weight-based dose. If no bowel movement in 72 hours, either oral bisacodyl or magnesium hydroxide, on a weight-based dosing, will be added. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- spinal fusion surgery
- current opioid use
- 12 years of age and older
- no or inadequate bowel movement by post-operative day 3
Key exclusion criteria (6 listed)
- known or expected mechanical bowel obstruction
- known or suspected lesions of the GI tract
- unexpected transfer to ICU
- unexpected return to the operating room
- patient or parent refusal of methylnaltrexone
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: RelistorPatient will receive methylnaltrexone on postoperative day 3 on a weight based dose and again 24 hours later if required. | Drug | Study group |
| Senna, docusate sodium, bisacodyl, magnesium hydroxide, MiralaxAlso: Senokot,Colace, Dulcolax, Milk of Magnesia, polyethylene glycolStandard institutional bowel protocol will begin on post-operative day 1. Miralax,Docusate sodium or senna will be given on a weight-based dosing. If no bowel movement in 72 hours, bisacodyl or magnesium hydroxide will be added. | Drug | Institutional bowel protocol, Study group |
Primary outcome
reduction of post-operative opioid induced constipation
Time frame: first post-operative week
1 secondary outcome
time to ambulation in post-operative pediatric spinal fusion patients
Time frame: first post-operative week
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 19 May 2015.
- Results publication: PubMed 21998076Anissian L, Schwartz HW, Vincent K, Vincent HK, Carpenito J, Stambler N, Ramakrishna T. Subcutaneous methylnaltrexone for treatment of acute opioid-induced constipation: phase 2 study in rehabilitation after orthopedic surgery. J Hosp Med. 2012 Feb;7(2):67-72. doi: 10.1002/jhm.943. Epub 2011 Oct 13.
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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.
Deborah J. Vermaire, M.D. principal investigator
Shriners Hospitals for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylnaltrexone and Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax in people with Constipation, run by Shriners Hospitals for Children 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 6 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 19 May 2015. 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 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 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?
reduction of post-operative opioid induced constipation (time frame: first post-operative week). 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 NCT01773096, which also lists 1 linked publication.
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 19 May 2015; AzTrials last refreshed its copy on 29 Oct 2026.