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CompletedNCT03235739Updated Sep 5, 2023Results posted

Ancillary Effects of Oral Naloxegol (Movantik)

A Phase 4 interventional study of Naloxegol 25 MG and Placebo in Pain, Postoperative, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-05.

Sponsored by The Cleveland Clinic · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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. About 130 surgery patients will participate in this study which is being conducted at Cleveland Clinic Main Campus.

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.

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Conditions studied

  • Pain, Postoperative

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.

This study's enrollment of 136 is above the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Severe hepatic impairment, with/or twice the upper normal levels of liver enzymes
  2. Severe renal impairment, or creatinine level > 2.0
  3. History of bladder cancer
  4. Patients receiving perioperative regional anesthesia blocks
  5. Presence of a sacral nerve stimulator
  6. Medications (anticholinergic agents such as antihistamines, phenothiazines, antidepressants, antipsychotics), conditions or comorbidity causing urinary retention
  7. Patient with requirement of urinary catheter insertion before or immediately post-surgery due to immobility
  8. Urinary Tract Infections and other urogenital comorbidity (incontinence, cysto-ureteric reflux, known bladder retention) or conditions which can cause urinary retention
  9. Severe peptic ulcer disease, diverticular disease, infiltrative gastrointestinal tract malignancies, or peritoneal metastases
  10. 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
  11. Gastrointestinal obstruction/Gastrointestinal perforation
  12. Strong CYP3A4 inhibitors (some antibiotics, antifungals, protease inhibitors, and antidepressants), Strong CYP3A4 inducers, Other opioid antagonists
  13. Hypersensitivity to MOVANTIK (naloxegol) or any of its excipients
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
136 participants (actual)

Study arms

  • Experimental
    Treatment Arm

    Naloxegol 25 mg given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first

    Drug: Naloxegol 25 MG

  • Placebo comparator
    Placebo Arm

    Matching placebo given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first

    Drug: Placebo

Interventions

  • DrugNaloxegol 25 MG

    Oral Naloxegol 25 MG

    Also known as: Movantik

  • DrugPlacebo

    matching oral placebo

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What researchers measure

Primary outcomes

  1. Residual Urine Volume

    Residual urine volume in the bladder as assessed by bladder scan

    Time frame: from Postoperative days 1 to POD 2 or until day of discharge whichever occurs first

Secondary outcomes

  1. 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.

    Time frame: Postoperative days 1-2 or until day of discharge whichever occurs first

  2. Need for Indwelling Urinary Catheterization

    Number of patients receiving Naloxegol requiring indwelling urinary catheters

    Time frame: Postoperative days 1-2 or until day of discharge whichever occurs first

  3. 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

    Time frame: Postoperative Days 2 or discharge day whichever was earlier

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Results

Posted Sep 5, 2023

Participant flow

of 508 patients screened, 136 patients meet all inclusion and exclusion criteria and gave consent to the study. 136 patients were randomized.

Participant flow — Overall Study
MilestoneTreatment-NaloxegolPlacebo Arm
Started6967
Completed6764
Not completed23
Withdrew: Withdrawal by subject22
Withdrew: Physician decision01

Outcome measures

PrimaryResidual Urine Volume

Residual urine volume in the bladder as assessed by bladder scan

Time frame:
from Postoperative days 1 to POD 2 or until day of discharge whichever occurs first
Reported as:
Median · ml
Residual Urine Volume
mlTreatment-NaloxegolPlacebo Arm
Day 1 AM62 (5 to 187)114 (13 to 247)
Day 1 PM48 (0 to 206)31 (0 to 169)
Day 2 AM32 (0 to 152)28 (0 to 122)
Day 2 PM0 (0 to 122)28 (0 to 66)
Statistical analysis
  • Treatment-Naloxegol · Mixed Models Analysis · p = 0.84 · Geometric mean ratio: 0.90 · 95% CI 0.32 to 2.55
  • Treatment-Naloxegol vs Placebo Arm · Mixed Models Analysis · p = 0.73 · Geometric mean ratio: 0.82 · 95% CI 0.26 to 2.56
SecondarySide 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.

Time frame:
Postoperative days 1-2 or until day of discharge whichever occurs first
Reported as:
Median · log(score on a scale)
Side Effects of Naloxegol on Other Opioid Related Side Effects
log(score on a scale)Treatment-NaloxegolPlacebo Arm
Day 10.53 (0.34 to 0.79)0.45 (0.31 to 0.81)
Day 20.34 (0.2 to 0.64)0.34 (0.13 to 0.62)
Statistical analysis
  • Treatment-Naloxegol vs Placebo Arm · Mixed Models Analysis · p = 0.91 · Geometric mean ratio: 1.02 · 98.3% CI 0.63 to 1.67
SecondaryNeed for Indwelling Urinary Catheterization

Number of patients receiving Naloxegol requiring indwelling urinary catheters

Time frame:
Postoperative days 1-2 or until day of discharge whichever occurs first
Reported as:
Count of participants · Participants
Need for Indwelling Urinary Catheterization
ParticipantsTreatment-NaloxegolPlacebo Arm
Need for Indwelling Urinary Catheterization197
Statistical analysis
  • Treatment-Naloxegol vs Placebo Arm · Chi-squared · p = 0.012 · Risk ratio (rr): 2.58 · 98.3% CI 0.98 to 6.80
SecondaryQuality 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

Time frame:
Postoperative Days 2 or discharge day whichever was earlier
Reported as:
Median · units on a scale
Quality of Recovery
units on a scaleTreatment-NaloxegolPlacebo Arm
Quality of Recovery119 (103 to 131)123 (115 to 133)
Statistical analysis
  • Treatment-Naloxegol vs Placebo Arm · Wilcoxon (Mann-Whitney) · p = 0.08 · Median of differences: -5 · 98.3% CI -12 to 2

Adverse events

Collected over until discharge from hospital, an average of 2 day, up to 3 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment-Naloxegol0/67 (0%)1/67 (1.5%)0/67 (0%)
Placebo Arm0/64 (0%)0/64 (0%)0/64 (0%)
Most frequent serious events
Most frequent serious events
EventTreatment-NaloxegolPlacebo Arm
Troponin elevation and ST elevationCardiac disorders1/670/64

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment-NaloxegolPlacebo ArmTotal
Mean64 ± 1362 ± 1163 ± 12
Sex: Female, Male
Sex: Female, Male(Participants)Treatment-NaloxegolPlacebo ArmTotal
Female323264
Male353267
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Treatment-NaloxegolPlacebo ArmTotal
Caucasian5957116
African American6511
Other101
Unknown123
ASA status
ASA status(Participants)Treatment-NaloxegolPlacebo ArmTotal
1112
281523
3524698
4628
Apfel PONV score
Apfel PONV score(units on a scale)Treatment-NaloxegolPlacebo ArmTotal
Median2 (2 to 3)2 (2 to 3)2 (2 to 3)
Chronic opioid use
Chronic opioid use(Participants)Treatment-NaloxegolPlacebo ArmTotal
Count of participants363268
Surgery type
Surgery type(Participants)Treatment-NaloxegolPlacebo ArmTotal
Hip6764131
Knee000
Surgery duration
Surgery duration(hours)Treatment-NaloxegolPlacebo ArmTotal
Median3.6 (2.9 to 4.7)3.5 (2.9 to 4.5)3.6 (2.9 to 4.5)

8 further baseline measures are reported on the registry.

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Study locations

1 site
  • The Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
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References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 26, 2019
  • Informed consent form · May 23, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Data to be provided in aggregate without patient identifiers

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03235739
Lead sponsor
The Cleveland Clinic
Responsible party
Alparslan Turan (Principal Investigator, The Cleveland Clinic) — Principal investigator
First posted
Aug 1, 2017
Start date
Oct 1, 2017
Primary completion
May 31, 2021
Completion
May 23, 2022
Results posted
Sep 5, 2023
Last update
Sep 5, 2023

Study contacts

Mehmet A Turan, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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