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Bladder CancerPhase 2ANTAGOCYSTNCT04219046

Evaluation of Naloxegol in the Prevention of POI After Cystectomy

A Phase 2 study testing Naloxégol oxalate in people with Bladder Cancer and Cystostomy; Complications, run by Institut Paoli-Calmettes.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Postoperative ileus (POI) is defined as a transient reduction of bowel motility that prevents effective transit of bowel content and tolerance of oral intake following surgical interventions, especially after radical cystectomy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer, Cystostomy; Complications
What is being tested?
Naloxégol oxalate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2032to Jan 2032
Phase
Phase 2
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

  • Patients aged ≥ 18 years
  • Informed consent signed
  • Histopathological confirmation of bladder cancer
  • Patients undergoing radical cystectomy and urinary diversion for an oncological indication
  • Patients able to understand the study procedures, agreed to participate in the study program
  • Patients affiliated to the national "Social Security" regimen or beneficiary of this regimen

Who cannot join

  • Unwilling to undergo cystectomy
  • Cystectomy for non-oncological indication
  • Patients with concomitant upper urinary tract disease
  • Previous total colectomy, gastrectomy, or gastric bypass, or functional colostomy or ileostomy
  • Previous pelvic radiotherapy for prostate or bladder cancer
  • Patients having taken opioids for more than seven days before surgery (to prevent peripheral withdrawal effects)
Show all 15Show fewer
  • Patients treated with drugs metabolized by certain enzymes (CYP3A4 and P-gp)
  • Patients with severe hepatic impairment
  • Patients with end-stage renal disease
  • Patients with heart failure
  • Patients with severe dementia that impacts daily functioning
  • Pregnant and lactating females
  • Not postmenopausal females and of childbearing potential and not using an accepted method of birth control (i.e, surgical sterilization; intrauterine contraceptive device; oral contraceptive, diaphragm)
  • Patients participated in another investigational drug or medical device study within 30 days of surgery or planning to be enrolled in another investigational drug or medical device study or any study in which active patient participation was required outside normal hospital data collection during the course of this study
  • Patients deprived of liberty or placed under the authority of a tutor or curator

About this study

Official title: Evaluation of Naloxegol, a Peripherally Acting µ-opioid Receptor Antagonist, in the Prevention of Postoperative Ileus After Cystectomy

Postoperative ileus (POI) is defined as a transient reduction of bowel motility that prevents effective transit of bowel content and tolerance of oral intake following surgical interventions, especially after radical cystectomy. It remains a major factor associated with postoperative morbidity, length of hospital stay and medical costs.

In order to optimize perioperative care for patients undergoing radical cystectomy in a context of an ERAS (Enhanced Recovery After Surgery) program, we will evaluate the effectiveness of systemic pharmacologic opioid antagonist treatment.

Read the detailed description

Radical cystectomy (RC) with urinary diversion represents the gold standard treatment for muscle-invasive bladder cancer. Postoperative ileus (POI) is defined as a transient reduction of bowel motility that prevents effective transit of bowel content and tolerance of oral intake following surgical interventions, especially after RC. It remains a major factor associated with postoperative morbidity, length of hospital stay and medical costs.

Faster gastrointestinal recovery and prevention of POI are at the heart of ERAS (Enhanced Recovery After Surgery) protocols. In order to optimize the post-operative consequences of patients operated on for a cystectomy within the framework of a RAAC program, several provisions aim to alleviate post-operative gastrointestinal dysfunctions.

Naloxegol, peripherally acting µ-opioid receptor antagonist, is currently approved for opioid-induced constipation in Chronic Non-Cancer Pain, but its potential interest to prevent POI has never been assessed. In this randomized, double-blind, placebo-controlled trial, the administration of Naloxegol for a limited duration as part of ERAS (Enhanced Recovery After Surgery) program will be evaluated to reduce the time of hospital discharge (length of stay) and to reduce the rate of postoperative complications. Priamry and secondary objectives will be compared between naloxegol and placebo groups.

Being tested
Naloxégol oxalate, Placebo oral tablet
Keywords
Radical cystectomy, Postoperative ileus, Enhanced Recovery After Surgery
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Naloxégol oxalateDrug

    Also called Naloxegol

    Oral administration once daily

  • Placebo oral tabletDrug

    Also called Placebo

    Oral administration once daily

Study groups in NCT04219046
Study groupRoleWhat they receive
Experimental TreatmentExperimentalERAS program with administration of experimental treatment: Naloxegol 25mg administrated once daily from surgery for up to 7 days
Receives: Drug: Naloxégol oxalate
PlaceboPlacebo comparatorERAS program with administration of placebo: Placebo administrated once daily from surgery for up to 7 days
Receives: Drug: Placebo oral tablet

What is being measured

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

  1. Time of hospital discharge

    Comparaison between treatment group and placebo group for post-operative length of stay between the date of hospital discharge and the date of surgery

    Measured: Date at which treatment is initiated and date of hospital discharge (up to 12 days)

Secondary outcomes (4)

  1. Rate of reinsertion of nasogastric tube

    Comparaison between treatment group and placebo group for rate of reinsertion of nasogastric tube

    Measured: From post-surgery to hospital discharge (up to 12 days)

  2. Time to reach gastrointestinal recovery

    Comparaison between treatment group and placebo group for time ot reach gastrointestinal recovery

    Measured: Date at which the patient has the first gaz from post-surgery (up to 12 days)

  3. Rate of 30-day postoperative complications

    Comparaison between treatment group and placebo group for rate of 30-day postoperative complications with Clavien-Dindo classification grade I-V

    Measured: Postoperative complications from surgery, to 30-day postsurgery and to 90 postsurgery with Clavien-Dindo classification (up to 3 motnhs)

  4. Rate of major postoperative complications of 90-day postoperative period

    Comparaison between treatment group and placebo group for rate of major postoperative complications with Clavien-Dindo classification grade III-IV-V

    Measured: Major postoperative complications from surgery to 90 postsurgery with Clavien-Dindo classification (up to 3 motnhs)

Timeline

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

  1. First posted6 Jan 2020
  2. Study startJan 2032 (estimated)
  3. Primary completionJan 2032 (estimated)
  4. Study completionJan 2032 (estimated)

Why it stopped: the industrial partner withdrew from the study

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Double-blind, placebo-controlled
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04219046
Sponsor's protocol ID
ANTAGOCYST-01-IPC 2019-034
Acronym
ANTAGOCYST
Status last verified
Oct 2026
First submitted
20 Dec 2019
Last updated
14 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Naloxégol oxalate in people with Bladder Cancer and Cystostomy; Complications, run by Institut Paoli-Calmettes.

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 6 inclusion and 15 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: withdrawn, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Time of hospital discharge (time frame: Date at which treatment is initiated and date of hospital discharge (up to 12 days)). 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 NCT04219046.

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 14 Oct 2026.

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