Constipation Drug InducedPhase 4NCT03523520
Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation
A Phase 4 study testing Methylnaltrexone Bromide 150 mg Oral Tablet, Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1 and Naloxegol 25 MG Oral Tablet in people with Constipation Drug Induced, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The purpose of this study is to compare the efficacy of subcutaneous versus oral mu-opioid receptor antagonist therapy in opioid induced constipation that is refractory to other bowel regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation Drug Induced
- What is being tested?
- Methylnaltrexone Bromide 150 mg Oral Tablet, Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1 and Naloxegol 25 MG Oral Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2020to 31 Mar 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Complaint of opioid-induced constipation refractory to other therapy (enemas, laxatives, stool softeners)
- Age≥18y/o
- Not pregnant or lactating (negative urinary pregnancy test)
- No contraindication to Methylnaltrexone or Naloxegol
Who cannot join
- Age<18y/o
- Pregnancy or lactation
- Contraindication to Methylnaltrexone or Naloxegol
- Assigned NPO
- Small bowel obstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Methylnaltrexone Versus Naloxegol in the Treatment of Opioid-Induced Constipation in the Emergency Department
The purpose of this study is to compare the efficacy of subcutaneous versus oral mu-opioid receptor antagonist therapy in opioid induced constipation that is refractory to other bowel regimens.
Read the detailed description
Opioid-induced constipation can lead to serious complications, including small bowel obstruction, fecal impaction, and bowel perforation. Not only are the medical complications potentially severe, patient quality of life can also be impacted. Two agents are currently available for opioid-induced constipation - oral and subcutaneous methylnaltrexone and oral naloxegol. Mechanistically, both agents antagonize the peripheral mu-opioid receptor in the gastrointestinal tract to decrease constipation without reversing the systemic analgesic effects of opiates. The literature currently available has evaluated the effectiveness of each agent, not the comparative effectiveness of these agents.
- Conditions
- Constipation Drug Induced
- Being tested
- Methylnaltrexone Bromide 150 mg Oral Tablet, Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1, Naloxegol 25 MG Oral Tablet
- Keywords
- constipation, opioid
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylnaltrexone Bromide 150 mg Oral TabletDrug
Also called Relistor
Methylnaltrexone Bromide 150 mg Oral Tablet
Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1Drug
Also called Relistor
Methylnaltrexone Bromide 12 MG Subcutaneous Solution
Naloxegol 25 MG Oral TabletDrug
Also called Movantik
Naloxegol 25 MG Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Methylnaltrexone oral tablets | Active comparator | Methylnaltrexone oral tablets (total 450 mg) + subcutaneous water injection
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. Receives: Drug: Methylnaltrexone Bromide 150 mg Oral Tablet |
| Methylnaltrexone subcutaneous injection | Active comparator | Methylnaltrexone 12mg subcutaneous injection + sugar placebo tablet
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. Receives: Drug: Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1 |
| Naloxegol oral tablets | Active comparator | Naloxegol oral tablets (total 25 mg) + subcutaneous water injection
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. Receives: Drug: Naloxegol 25 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Bowl Movement
The primary outcome of this study is to determine the effectiveness of peripherally acting mu-opioid receptor antagonist therapy for patients presenting to the emergency department (ED) with opioid-induced constipation.
Measured: 24 hours
Secondary outcomes (1)
Time to Bowl Movement Within 24 Hours
The secondary outcome of this study is the time to effectiveness of subcutaneous versus oral therapy.
Measured: 24 hours after administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start23 Dec 2020
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Constipation Drug InducedStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Model description
- Participants will be assigned to one of three groups i. Methylnaltrexone oral tablets (total 450 mg) + subcutaneous water injection ii. Methylnaltrexone 12mg subcutaneous injection + placebo sugar tablets iii. Naloxegol oral tablets (total 25 mg) + subcutaneous water injection
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kara B. Goddard, PharmD, BCPS, University of Missouri-Columbia
- Investigators
- KARA B GODDARD, PharmD, BCPS, Principal investigator, UNIVERSITY OF MISSOURI HEALTH CARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523520
- Sponsor's protocol ID
- 2011409 HS
- Status last verified
- Sep 2024
- First submitted
- 1 May 2018
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bowers BL, Crannage AJ. The Evolving Role of Long-Term Pharmacotherapy for Opioid-Induced Constipation in Patients Being Treated for Noncancer Pain. J Pharm Pract. 2019 Oct;32(5):558-567. doi: 10.1177/0897190017745395. Epub 2017 Dec 5.
PubMed 29207909Jones R, Prommer E, Backstedt D. Naloxegol: A Novel Therapy in the Management of Opioid-Induced Constipation. Am J Hosp Palliat Care. 2016 Nov;33(9):875-880. doi: 10.1177/1049909115593937. Epub 2015 Jul 6.
PubMed 26150678Anantharamu T, Sharma S, Gupta AK, Dahiya N, Singh Brashier DB, Sharma AK. Naloxegol: First oral peripherally acting mu opioid receptor antagonists for opioid-induced constipation. J Pharmacol Pharmacother. 2015 Jul-Sep;6(3):188-92. doi: 10.4103/0976-500X.162015.
PubMed 26312011
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylnaltrexone Versus Naloxegol in the Treatment of Opioid-Induced Constipation in the Emergency Department
- ClinicalTrials.gov ID
- NCT03523520
- Acronym / sponsor ID
- 2011409 HS
- Conditions
- Constipation Drug Induced
- Keywords
- constipation, opioid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Posted 19 Sep 2024
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 compare the efficacy of subcutaneous versus oral mu-opioid receptor antagonist therapy in opioid induced constipation that is refractory to other bowel regimens.
Detailed description
Opioid-induced constipation can lead to serious complications, including small bowel obstruction, fecal impaction, and bowel perforation. Not only are the medical complications potentially severe, patient quality of life can also be impacted. Two agents are currently available for opioid-induced constipation - oral and subcutaneous methylnaltrexone and oral naloxegol. Mechanistically, both agents antagonize the peripheral mu-opioid receptor in the gastrointestinal tract to decrease constipation without reversing the systemic analgesic effects of opiates. The literature currently available has evaluated the effectiveness of each agent, not the comparative effectiveness of these agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Participants will be assigned to one of three groups i. Methylnaltrexone oral tablets (total 450 mg) + subcutaneous water injection ii. Methylnaltrexone 12mg subcutaneous injection + placebo sugar tablets iii. Naloxegol oral tablets (total 25 mg) + subcutaneous water injection
| Arm | Type | Receives |
|---|---|---|
| Methylnaltrexone oral tablets | Active comparator | Drug: Methylnaltrexone Bromide 150 mg Oral TabletMethylnaltrexone oral tablets (total 450 mg) + subcutaneous water injection Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. |
| Methylnaltrexone subcutaneous injection | Active comparator | Drug: Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1Methylnaltrexone 12mg subcutaneous injection + sugar placebo tablet Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. |
| Naloxegol oral tablets | Active comparator | Drug: Naloxegol 25 MG Oral TabletNaloxegol oral tablets (total 25 mg) + subcutaneous water injection Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Complaint of opioid-induced constipation refractory to other therapy (enemas, laxatives, stool softeners)
- Age≥18y/o
- Not pregnant or lactating (negative urinary pregnancy test)
- No contraindication to Methylnaltrexone or Naloxegol
Key exclusion criteria (5 listed)
- Age<18y/o
- Pregnancy or lactation
- Contraindication to Methylnaltrexone or Naloxegol
- Assigned NPO
- Small bowel obstruction
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 |
|---|---|---|
| Methylnaltrexone Bromide 150 mg Oral TabletAlso: RelistorMethylnaltrexone Bromide 150 mg Oral Tablet | Drug | Methylnaltrexone oral tablets |
| Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1Also: RelistorMethylnaltrexone Bromide 12 MG Subcutaneous Solution | Drug | Methylnaltrexone subcutaneous injection |
| Naloxegol 25 MG Oral TabletAlso: MovantikNaloxegol 25 MG Oral Tablet | Drug | Naloxegol oral tablets |
Primary outcome
Occurrence of Bowl Movement
Time frame: 24 hours
The primary outcome of this study is to determine the effectiveness of peripherally acting mu-opioid receptor antagonist therapy for patients presenting to the emergency department (ED) with opioid-induced constipation.
1 secondary outcome
Time to Bowl Movement Within 24 Hours
Time frame: 24 hours after administration of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29207909Bowers BL, Crannage AJ. The Evolving Role of Long-Term Pharmacotherapy for Opioid-Induced Constipation in Patients Being Treated for Noncancer Pain. J Pharm Pract. 2019 Oct;32(5):558-567. doi: 10.1177/0897190017745395. Epub 2017 Dec 5.
- Results publication: PubMed 26150678Jones R, Prommer E, Backstedt D. Naloxegol: A Novel Therapy in the Management of Opioid-Induced Constipation. Am J Hosp Palliat Care. 2016 Nov;33(9):875-880. doi: 10.1177/1049909115593937. Epub 2015 Jul 6.
- Results publication: PubMed 26312011Anantharamu T, Sharma S, Gupta AK, Dahiya N, Singh Brashier DB, Sharma AK. Naloxegol: First oral peripherally acting mu opioid receptor antagonists for opioid-induced constipation. J Pharmacol Pharmacother. 2015 Jul-Sep;6(3):188-92. doi: 10.4103/0976-500X.162015.
- Individual participant dataSharing planned: No
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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.
KARA B GODDARD, PharmD, BCPS principal investigator
UNIVERSITY OF MISSOURI HEALTH CARE
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 Bromide 150 mg Oral Tablet, Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1 and Naloxegol 25 MG Oral Tablet in people with Constipation Drug Induced, run by University of Missouri-Columbia 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 5 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 Sep 2024. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Occurrence of Bowl Movement (time frame: 24 hours). 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 NCT03523520, which also lists 3 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 19 Sep 2024.