Pain, PostoperativePhase 4NCT03235739

Ancillary Effects of Oral Naloxegol (Movantik)

A Phase 4 study testing Naloxegol 25 MG in people with Pain, Postoperative, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to find out whether oral Naloxegol can reduce the side effects of opioid painkillers following surgery. This study aims to explore whether Naloxegol can similarly reduce opioid-induced side effects in post-surgical patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Postoperative
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: 136 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2017to 23 May 2022
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

Provision of informed consent prior to any study specific procedures
Female or male aged at least 18 years
American Society of Anesthesiologists physical status 1-4;
Scheduled for elective primary hip or knee surgery under spinal anesthesia;
Expected to receive intravenous patient-controlled analgesia (IV PCA)
Expected to have significant postoperative pain
Negative pregnancy test

Who cannot join

Severe hepatic impairment, with/or twice the upper normal levels of liver enzymes
Severe renal impairment, or creatinine level > 2.0
History of bladder cancer
Patients receiving perioperative regional anesthesia blocks
Presence of a sacral nerve stimulator
Medications (anticholinergic agents such as antihistamines, phenothiazines, antidepressants, antipsychotics), conditions or comorbidity causing urinary retention

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Patient with requirement of urinary catheter insertion before or immediately post-surgery due to immobility
Urinary Tract Infections and other urogenital comorbidity (incontinence, cysto-ureteric reflux, known bladder retention) or conditions which can cause urinary retention
Severe peptic ulcer disease, diverticular disease, infiltrative gastrointestinal tract malignancies, or peritoneal metastases
Patients with known or suspected disruption of blood brain barrier, which may include but not limited to: Alzheimer's disease, stroke, poliomyelitis, cerebral palsy, multiple sclerosis, spinal lesions, and Parkinson's disease
Gastrointestinal obstruction/Gastrointestinal perforation
Strong CYP3A4 inhibitors (some antibiotics, antifungals, protease inhibitors, and antidepressants), Strong CYP3A4 inducers, Other opioid antagonists
Hypersensitivity to MOVANTIK (naloxegol) or any of its excipients

Trial locations and contacts

1 site in 1 country.

United States1 site

The Cleveland Clinic Foundation
Cleveland, Ohio, 44195

Other trials in United States

About this study

Read the detailed description

Opioids are the gold standard for postoperative pain management, but they have been shown to produce uncomfortable side effects such as urinary retention (an inability to completely empty the bladder), constipation and nausea/vomiting. Clinical evidence demonstrates that Naloxegol can safely and effectively block these undesirable side effects while maintaining the painkilling effects of opioids in outpatients suffering from opioid-induced constipation.

Conditions: Pain, Postoperative
Being tested: Naloxegol 25 MG, Placebo
Medical subject headings: Pain, Postoperative

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
Oral Naloxegol 25 MG
PlaceboDrug
matching oral placebo

Study groups in NCT03235739
Study group	Role	What they receive
Treatment Arm	Experimental	Naloxegol 25 mg given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first Receives: Drug: Naloxegol 25 MG
Placebo Arm	Placebo comparator	Matching placebo given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Residual Urine Volume
Residual urine volume in the bladder as assessed by bladder scan
Measured: from Postoperative days 1 to POD 2 or until day of discharge whichever occurs first

Secondary outcomes (3)

Side Effects of Naloxegol on Other Opioid Related Side Effects
Opioid-related Symptom Distress Scale (ORSDS) is a 4 point-scale that evaluates three symptom distress dimensions (frequency, severity, bothersomeness) for opioid-related side effects. The 12 elements of the ORSDS are nausea, vomiting, constipation, difficulty passing urine, difficulty concentrating, drowsiness, lightheaded, fatigue, feeling confused, itchiness, dry mouth, and headache. The ORSDS questionnaire was administered by a trained investigator on first and second postoperative days while patients remained hospitalized. We reported the average ORSDS score from all 12 elements, which ranged from 0 to 4 and higher scores represent worse outcome.
Measured: Postoperative days 1-2 or until day of discharge whichever occurs first
Need for Indwelling Urinary Catheterization
Number of patients receiving Naloxegol requiring indwelling urinary catheters
Measured: Postoperative days 1-2 or until day of discharge whichever occurs first
Quality of Recovery
Quality of recovery is a validated scoring system that quantifies patients' early postoperative health status with range of 0-150 where higher score means better quality of recovery. We used the 15-question version, the QoR-15
Measured: Postoperative Days 2 or discharge day whichever was earlier

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201723 May 2022

First posted1 Aug 2017
Study start1 Oct 2017
Primary completion31 May 2021
Study completion23 May 2022

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.
Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe 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: Effect of Naloxegol on reversing opioid-related side effects in patients recovering from elective primary hip surgery under spinal anesthesia who will be randomly assigned to oral Naloxegol or placebo for two postoperative days or until the date of discharge, whichever occurs earlier. The design will be a randomized, double-blind, placebo-controlled trial of oral Naloxegol in adults having elective primary hip or knee surgery under spinal anesthesia. The study will be performed at the Cleveland Clinic hospitals.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 136 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03235739
Sponsor's protocol ID: 17-765
Status last verified: Aug 2023
First submitted: 18 Jul 2017
Last updated: 5 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Data to be provided in aggregate without patient identifiers

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pain, Postoperative trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ancillary Effects of Oral Naloxegol (Movantik)
ClinicalTrials.gov ID: NCT03235739
Acronym / sponsor ID: 17-765
Conditions: Pain, Postoperative
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 136 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Study start: 1 Oct 2017 (actual)
Primary completion: 31 May 2021 (actual)
Study completion: 23 May 2022 (actual)
First posted: 1 Aug 2017 (actual)
Results: Posted 5 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: Effect of Naloxegol on reversing opioid-related side effects in patients recovering from elective primary hip surgery under spinal anesthesia who will be randomly assigned to oral Naloxegol or placebo for two postoperative days or until the date of discharge, whichever occurs earlier. The design will be a randomized, double-blind, placebo-controlled trial of oral Naloxegol in adults having elective primary hip or knee surgery under spinal anesthesia. The study will be performed at the Cleveland Clinic hospitals.

Arm	Type	Receives
Treatment Arm	Experimental	Drug: Naloxegol 25 MGNaloxegol 25 mg given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first
Placebo Arm	Placebo comparator	Drug: PlaceboMatching placebo given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Provision of informed consent prior to any study specific procedures
Female or male aged at least 18 years
American Society of Anesthesiologists physical status 1-4;
Scheduled for elective primary hip or knee surgery under spinal anesthesia;
Expected to receive intravenous patient-controlled analgesia (IV PCA)

Key exclusion criteria (13 listed)

Severe hepatic impairment, with/or twice the upper normal levels of liver enzymes
Severe renal impairment, or creatinine level > 2.0
History of bladder cancer
Patients receiving perioperative regional anesthesia blocks
Presence of a sacral nerve stimulator

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: MovantikOral Naloxegol 25 MG	Drug	Treatment Arm
Placebomatching oral placebo	Drug	Placebo Arm

Primary outcome

Residual Urine Volume
Time frame: from Postoperative days 1 to POD 2 or until day of discharge whichever occurs first
Residual urine volume in the bladder as assessed by bladder scan

3 secondary outcomes

Side Effects of Naloxegol on Other Opioid Related Side Effects
Time frame: Postoperative days 1-2 or until day of discharge whichever occurs first
Need for Indwelling Urinary Catheterization
Time frame: Postoperative days 1-2 or until day of discharge whichever occurs first
Quality of Recovery
Time frame: Postoperative Days 2 or discharge day whichever was earlier

Results and safety

Results posted to the registry on 5 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment-Naloxegol	69	67
Placebo Arm	67	64

Primary outcome: Residual Urine Volume

Time frame: from Postoperative days 1 to POD 2 or until day of discharge whichever occurs first. Median (Inter-Quartile Range). Unit: ml

Measure	Treatment-Naloxegol n = 59	Placebo Arm n = 55
Day 1 AM	62 (5 to 187)	114 (13 to 247)
Day 1 PM	48 (0 to 206)	31 (0 to 169)
Day 2 AM	32 (0 to 152)	28 (0 to 122)
Day 2 PM	0 (0 to 122)	28 (0 to 66)

Treatment-Naloxegol: geometric mean ratio: 0.90 (95% CI 0.32 to 2.55), p = 0.84, Mixed Models Analysis
Treatment-Naloxegol vs Placebo Arm: geometric mean ratio: 0.82 (95% CI 0.26 to 2.56), p = 0.73, Mixed Models Analysis

Population analysed: 17 patients were completely missing on urine residual. Multiple imputation was used solely for estimating the treatment effect on urinal residual. The summary statistics of urine residual for each day was reported based on original data.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: until discharge from hospital, an average of 2 day, up to 3 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment-Naloxegol	1 of 67 (1.5%)	0 of 67 (0%)	0 of 67
Placebo Arm	0 of 64 (0%)	0 of 64 (0%)	0 of 64

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Data to be provided in aggregate without patient identifiers

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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.

Mehmet A Turan, MD principal investigator

The Cleveland Clinic

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 Naloxegol 25 MG in people with Pain, Postoperative, run by The Cleveland Clinic 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 7 inclusion and 13 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 5 Sep 2023. 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 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 5 Sep 2023). 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?

Residual Urine Volume (time frame: from Postoperative days 1 to POD 2 or until day of discharge whichever occurs first). 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 NCT03235739.

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 Sep 2023.