ConstipationPhase 2/3NCT03316859
Naloxegol and Opioid-induced Constipation
A Phase 2/3 study testing Naloxegol 25 MG in people with Constipation and Constipation Drug Induced, run by TriHealth Inc. at 1 site in United States.
Trial summary
This is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-operative regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation, Constipation Drug Induced
- What is being tested?
- Naloxegol 25 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2017to 1 Dec 2022
- Phase
- Phase 2/3
- 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
- Scheduled to undergo elective cardiac surgery at Bethesda North TriHealth Hospital
- Admitted to Bethesda North TriHealth Hospital CVICU post-surgery
Who cannot join
- Medically unstable
- Cognitive deficits that impair the patient's ability to understand the informed consent
- Language barriers
- Patient has a documented diagnosis of one of the following: Crohn's disease; Ulcerative Colitis; History of bowel surgery that will impact absorption of study drug (as deemed by physician); History of small bowel obstruction
- Chronic constipation requiring subject to take one of the following medications on a daily basis prior to time of consent: Linzess, Trulance, Amitza, Senna/Senokot, Colace, Dulcolax, Miralax, Metamucil
- Patients on following medications prior to time of consent: Diltiazem, Verapamil, Amiodarone, Ketoconazole, Clarithromycin/ erythromycin, Antivirals
- Conditions that present an increased risk of bowel perforation (as determined by the physician)
- Pre-existing diagnosis of opioid-induced constipation AND receiving naloxegol as a treatment by their physician
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Bethesda North TriHealth Hospital
Cincinnati, Ohio, 45242
Jocelyn LaMar, BS, 513-865-5072, Jocelyn_LaMar@trihealth.com
About this study
Official title: A Prospective Randomized, Double-Blind Study to Evaluate the Addition of Naloxegol to the Pre-Op Regimen of the Cardiac Surgery Patient and Its Effect on Opioid-Induced Constipation
This is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-operative regimen.
Read the detailed description
This is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-op regimen. There will be 140 subjects per study group. The patient and treating physician/nurse will be blinded as to which group the subject is assigned. On the day of surgery, subjects in both groups will complete a questionnaire to assess compliance with prescribed pre-operative regimen. Subjects in both groups will receive post-operative bowel regimen in the cardiovascular intensive care unit (CVICU) according to current standard of care, including procedures for rescue medications for constipation prevention and induction of a bowel movement.
- Conditions
- Constipation, Constipation Drug Induced
- Being tested
- Naloxegol 25 MG, Placebo pill
- Keywords
- opioid-induced constipation (OIC)
- Medical subject headings
- Constipation, Opioid-Induced Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naloxegol 25 MGDrug
Also called Movantik
Naloxegol 25 mg administered 1 hour pre-operatively
Placebo pillOther
Placebo pill administered 1 hour pre-operatively
| Study group | Role | What they receive |
|---|---|---|
| Naloxegol | Experimental | naloxegol 25 mg pill Receives: Drug: Naloxegol 25 MG |
| Placebo | Placebo comparator | placebo pill Receives: Other: Placebo pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to substantial bowel movement
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Measured: Post-operative day 1
Time to substantial bowel movement
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Measured: Post-operative day 2
Time to substantial bowel movement
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Measured: Post-operative day 3
Time to substantial bowel movement
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Measured: Post-operative day 4
Time to substantial bowel movement
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Measured: Post-operative day 5
Secondary outcomes (5)
Rescue medications
Amount of rescue medications
Measured: Post-operative day 1
Rescue medications
Amount of rescue medications
Measured: Post-operative day 2
Rescue medications
Amount of rescue medications
Measured: Post-operative day 3
Rescue medications
Amount of rescue medications
Measured: Post-operative day 4
Rescue medications
Amount of rescue medications
Measured: Post-operative day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start6 Nov 2017
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott McCardle, MD, Principal investigator, Bethesda North TriHealth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316859
- Sponsor's protocol ID
- 17-020
- Status last verified
- Jun 2021
- First submitted
- 17 Oct 2017
- Last updated
- 5 May 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chey WD, Webster L, Sostek M, Lappalainen J, Barker PN, Tack J. Naloxegol for opioid-induced constipation in patients with noncancer pain. N Engl J Med. 2014 Jun 19;370(25):2387-96. doi: 10.1056/NEJMoa1310246. Epub 2014 Jun 4.
PubMed 24896818DePriest AZ, Miller K. Oxycodone/Naloxone: role in chronic pain management, opioid-induced constipation, and abuse deterrence. Pain Ther. 2014 Jun;3(1):1-15. doi: 10.1007/s40122-014-0026-2. Epub 2014 May 6.
PubMed 25135384Nelson AD, Camilleri M. Chronic opioid induced constipation in patients with nonmalignant pain: challenges and opportunities. Ther Adv Gastroenterol. 2015 Jul;8(4):206-20. doi: 10.1177/1756283X15578608.
PubMed 26136838
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized, Double-Blind Study to Evaluate the Addition of Naloxegol to the Pre-Op Regimen of the Cardiac Surgery Patient and Its Effect on Opioid-Induced Constipation
- ClinicalTrials.gov ID
- NCT03316859
- Acronym / sponsor ID
- 17-020
- Conditions
- Constipation, Constipation Drug Induced
- Keywords
- opioid-induced constipation (OIC)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 20 Oct 2017 (actual)
- 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 double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-operative regimen.
Detailed description
This is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-op regimen. There will be 140 subjects per study group. The patient and treating physician/nurse will be blinded as to which group the subject is assigned. On the day of surgery, subjects in both groups will complete a questionnaire to assess compliance with prescribed pre-operative regimen. Subjects in both groups will receive post-operative bowel regimen in the cardiovascular intensive care unit (CVICU) according to current standard of care, including procedures for rescue medications for constipation prevention and induction of a bowel movement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naloxegol | Experimental | Drug: Naloxegol 25 MGnaloxegol 25 mg pill |
| Placebo | Placebo comparator | Other: Placebo pillplacebo pill |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled to undergo elective cardiac surgery at Bethesda North TriHealth Hospital
- Admitted to Bethesda North TriHealth Hospital CVICU post-surgery
Key exclusion criteria (8 listed)
- Medically unstable
- Cognitive deficits that impair the patient's ability to understand the informed consent
- Language barriers
- Patient has a documented diagnosis of one of the following: Crohn's disease; Ulcerative Colitis; History of bowel surgery that will impact absorption of study drug (as deemed by physician); History of small bowel obstruction
- Chronic constipation requiring subject to take one of the following medications on a daily basis prior to time of consent: Linzess, Trulance, Amitza, Senna/Senokot, Colace, Dulcolax, Miralax, Metamucil
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 |
|---|---|---|
| Naloxegol 25 MGAlso: MovantikNaloxegol 25 mg administered 1 hour pre-operatively | Drug | Naloxegol |
| Placebo pillPlacebo pill administered 1 hour pre-operatively | Other | Placebo |
Primary outcome
Time to substantial bowel movement
Time frame: Post-operative day 1
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Time to substantial bowel movement
Time frame: Post-operative day 2
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Time to substantial bowel movement
Time frame: Post-operative day 3
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Time to substantial bowel movement
Time frame: Post-operative day 4
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Time to substantial bowel movement
Time frame: Post-operative day 5
Time to bowel movement of Type 2 or higher on the Bristol stool chart
5 secondary outcomes
Rescue medications
Time frame: Post-operative day 1
Rescue medications
Time frame: Post-operative day 2
Rescue medications
Time frame: Post-operative day 3
Rescue medications
Time frame: Post-operative day 4
Rescue medications
Time frame: Post-operative day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Background: PubMed 24896818Chey WD, Webster L, Sostek M, Lappalainen J, Barker PN, Tack J. Naloxegol for opioid-induced constipation in patients with noncancer pain. N Engl J Med. 2014 Jun 19;370(25):2387-96. doi: 10.1056/NEJMoa1310246. Epub 2014 Jun 4.
- Background: PubMed 25135384DePriest AZ, Miller K. Oxycodone/Naloxone: role in chronic pain management, opioid-induced constipation, and abuse deterrence. Pain Ther. 2014 Jun;3(1):1-15. doi: 10.1007/s40122-014-0026-2. Epub 2014 May 6.
- Background: PubMed 26136838Nelson AD, Camilleri M. Chronic opioid induced constipation in patients with nonmalignant pain: challenges and opportunities. Ther Adv Gastroenterol. 2015 Jul;8(4):206-20. doi: 10.1177/1756283X15578608.
- 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.
Scott McCardle, MD principal investigator
Bethesda North TriHealth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Naloxegol 25 MG in people with Constipation and Constipation Drug Induced, run by TriHealth 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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 5 May 2022. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jocelyn LaMar, BS (513-865-5072, Jocelyn_LaMar@trihealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to substantial bowel movement (time frame: Post-operative day 1). The study lists 5 primary outcomes in all. 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 NCT03316859, 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 5 May 2022.