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Ileus PostoperativePhase 2ORE001PIIPOINCT05923086

Preventing Gastrointestinal Disturbance in Patients After Longitudinal Laparotomy.

A Phase 2 study testing ORE001 in people with Ileus Postoperative, run by Orexa BV at 3 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a multi-center, randomized, double blind, placebo-controlled, phase 2 pilot efficacy study. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Ileus Postoperative
What is being tested?
ORE001
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
126 participants
Where
3 sitesGermany
Study dates
11 Jan 2024to 31 Dec 2025
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must be able to understand the requirements of the study and give written informed consent prior to study start.
  • Female patients aged between 18 and 75 years (both inclusive).
  • Gynecologic surgery performed completely by longitudinal laparotomy.
  • Patient with ECOG Performance status up to 1.
  • Patient is highly likely to comply with the protocol and complete the study.
  • Patient agrees to be scheduled for peridural catheter (PDC).

Who cannot join

  • Patient has a history of gastrectomy, total colectomy, stoma creation, short bowel syndrome.
  • Patient has pre-operative ileus.
  • Patient is taking opioid analgesics longer than two post-operative days, exceeding a dosing of 35 mg morphine equivalent per day.
  • Chemotherapy treatment within 10 days after longitudinal surgery.
  • Smoking during the hospital stay.
  • Any contraindication as per summary of product characteristic for the usage of local anesthetics for PDC.
Show all 16Show fewer
  • History of uncontrolled (at the discretion of the Investigator) cardiovascular, renal and/or hepatic failure.
  • History of severe allergic or anaphylactic reactions, especially to local anesthetics.
  • Clinically significant (at the discretion of the Investigator) deviation from the normal laboratory values.
  • Clinically significant (at the discretion of the Investigator) abnormal ECG.
  • Intake of any class 1B antiarrhythmic drugs if used for antiarrhythmic purpose (e.g., Lidocaine, Mexiletine, Phenytoin) and of any class 3 antiarrhythmic drugs - Kalium channel blockers (e.g., Amiodarone, Dronedarone, Sotalol, Ibutilide, Dofetilide, Bretylium).
  • Significant (at the discretion of the Investigator) symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection (especially with need of antibiotic treatment) within the past 2 weeks prior to study medication administration.
  • Experimental agent within 30 days or ten half-lives, whichever is longer, prior to study medication administration.
  • Pregnancy or planning to become pregnant during the study.
  • Any other condition, which in the opinion of the Investigator precludes the patient's participation in the study.
  • Patients with close affiliation with the Investigator or persons working at the respective study sites or patients who are an employee of the Sponsor.

Trial locations and contacts

3 sites in 1 country.

Ard Peeters, Prof. contact

0652383983

ardpeeters@orexa.nl

Germany3 sites, 3 recruiting

  • Universitätsklinikum Bonn (UKB).

    Bonn

    A Mustea, Prof

    Recruiting

  • Kaiserswerther Diakonie Florence-Nightingale- Krankenhaus

    Düsseldorf, 40489

    Recruiting

  • Klinikum Wolfsburg

    Wolfsburg, 38440

    Recruiting

Other trials in Germany

About this study

Official title: A Multi-center, Randomized, Double Blind, Placebo-controlled, Phase 2 Study to Investigate the Efficacy of ORE-001 in Preventing Gastrointestinal Disturbance/ Intolerance in Patients After Longitudinal Laparotomy

This is a multi-center, randomized, double blind, placebo-controlled, phase 2 pilot efficacy study.

Read the detailed description

After assessing eligibility during a screening period (up to 4 weeks before planned surgery), up to 126 female patients are planned to be randomized to one of the two treatment groups.

After the surgery, at POD1 (Post Operative Day 1), all patients will receive the oral study drug (ORE-001 4x 100 mg or 4x placebo) 15-30 minutes before intake of the semi-solid main meal (lunch).

Clinical assessments of efficacy will be conducted based on I-FEED score and VAS (Visual Analogue Scale) abdominal pain score at POD1 to POD8 (or up to POD12 if extended), and the impact of the treatment on the Quality of Life (QoL) of the patients at POD8 (or at POD9 up to POD12 if extended) and at Follow up (FU) in comparison to Baseline values. The impact of the treatment on the QoL will be done by using the specific 36-Item Short Form Survey Instrument (SF-36) QoL questionnaire.

Adverse events (AEs) will be recorded from POD1 to EOS continuously, concomitant medication, and other assessments including vital signs and body weight will be recorded throughout the study (Screening to EOS (End Of Study)).

Urine pregnancy tests (only for females of childbearing potential) will be performed at Screening and Baseline. 12-lead ECG will be performed at Screening, Baseline, POD1 and at Day after last study drug administration.

Safety laboratory assessments on blood (hematology and biochemistry) and urine (routine dip stick test) will be conducted at Screening, Baseline, POD1 and from POD4 every second day until one day after last IMP administration to assess for any changes in the safety endpoints.

Blood albumin will be analyzed on Screening, Baseline, and every POD until one day after last IMP administration to assess for any changes in the safety endpoints.

Interleukin 6 will be analyzed at POD1 and POD6. Patients prematurely terminating the study after administration of at least one dose of the study drug should be subjected to a final examination including safety laboratory assessment.

Being tested
ORE001, Placebo
Keywords
local anesthetic

What participants receive

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

  • ORE001Drug

    Also called Lidocaine

    Administration before major meal

  • PlaceboDrug

    Administration before major meal

Study groups in NCT05923086
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo treatment (4 tablets)
Receives: Drug: Placebo
ORE001ExperimentalORE001 treatment (4 tablets)
Receives: Drug: ORE001

What is being measured

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

  1. I-FEED Post Operative Day 3

    To evaluate the efficacy of oral ORE-001 compared to placebo in reducing the gastrointestinal disturbance/intolerance and the occurrence of postoperative ileus (POI) in patients after longitudinal laparotomy defined by scoring of the postoperative I-FEED scores at POD3. The I-FEED score ranges from 0 to 14. The higher the score the more severe are the symptoms.

    Measured: Post Operative Day 3

Secondary outcomes (12)

  1. I-FEED Post Operative Day 1

    To evaluate the efficacy of oral ORE-001 compared to placebo in reducing the gastrointestinal disturbance/intolerance and the occurrence of postoperative ileus (POI) in patients after longitudinal laparotomy defined by scoring of the postoperative I-FEED scores at POD1. The I-FEED score ranges from 0 to 14. The higher the score the more severe are the symptoms.

    Measured: Post Operative Day 1

  2. I-FEED Post Operative Day 2

    To evaluate the efficacy of oral ORE-001 compared to placebo in reducing the gastrointestinal disturbance/intolerance and the occurrence of postoperative ileus (POI) in patients after longitudinal laparotomy defined by scoring of the postoperative I-FEED scores at POD2. The I-FEED score ranges from 0 to 14. The higher the score the more severe are the symptoms.

    Measured: Post Operative Day 2

  3. I-FEED Post Operative Day 4

    To evaluate the efficacy of oral ORE-001 compared to placebo in reducing the gastrointestinal disturbance/intolerance and the occurrence of postoperative ileus (POI) in patients after longitudinal laparotomy defined by scoring of the postoperative I-FEED scores at POD4. The I-FEED score ranges from 0 to 14. The higher the score the more severe are the symptoms.

    Measured: Post Operative Day 4

  4. I-FEED Post Operative Day 5

    To evaluate the efficacy of oral ORE-001 compared to placebo in reducing the gastrointestinal disturbance/intolerance and the occurrence of postoperative ileus (POI) in patients after longitudinal laparotomy defined by scoring of the postoperative I-FEED scores at POD5. The I-FEED score ranges from 0 to 14. The higher the score the more severe are the symptoms.

    Measured: Post Operative Day 5

  5. I-FEED Post Operative Day 6

    To evaluate the efficacy of oral ORE-001 compared to placebo in reducing the gastrointestinal disturbance/intolerance and the occurrence of postoperative ileus (POI) in patients after longitudinal laparotomy defined by scoring of the postoperative I-FEED scores at POD6. The I-FEED score ranges from 0 to 14. The higher the score the more severe are the symptoms.

    Measured: Post Operative Day 6

  6. I-FEED Post Operative Day 7

    To evaluate the efficacy of oral ORE-001 compared to placebo in reducing the gastrointestinal disturbance/intolerance and the occurrence of postoperative ileus (POI) in patients after longitudinal laparotomy defined by scoring of the postoperative I-FEED scores at POD7. The I-FEED score ranges from 0 to 14. The higher the score the more severe are the symptoms.

    Measured: Post Operative Day 7

  7. I-FEED Post Operative Day 8

    To evaluate the efficacy of oral ORE-001 compared to placebo in reducing the gastrointestinal disturbance/intolerance and the occurrence of postoperative ileus (POI) in patients after longitudinal laparotomy defined by scoring of the postoperative I-FEED scores at POD8. The I-FEED score ranges from 0 to 14. The higher the score the more severe are the symptoms.

    Measured: Post Operative Day 8

  8. I-FEED Post Operative Day 9

    To evaluate the efficacy of oral ORE-001 compared to placebo in reducing the gastrointestinal disturbance/intolerance and the occurrence of postoperative ileus (POI) in patients after longitudinal laparotomy defined by scoring of the postoperative I-FEED scores at POD9. The I-FEED score ranges from 0 to 14. The higher the score the more severe are the symptoms.

    Measured: Post Operative Day 9

  9. I-FEED Post Operative Day 10

    To evaluate the efficacy of oral ORE-001 compared to placebo in reducing the gastrointestinal disturbance/intolerance and the occurrence of postoperative ileus (POI) in patients after longitudinal laparotomy defined by scoring of the postoperative I-FEED scores at POD10. The I-FEED score ranges from 0 to 14. The higher the score the more severe are the symptoms.

    Measured: Post Operative Day 10

  10. I-FEED Post Operative Day 11

    To evaluate the efficacy of oral ORE-001 compared to placebo in reducing the gastrointestinal disturbance/intolerance and the occurrence of postoperative ileus (POI) in patients after longitudinal laparotomy defined by scoring of the postoperative I-FEED scores at POD11. The I-FEED score ranges from 0 to 14. The higher the score the more severe are the symptoms.

    Measured: Post Operative Day 11

  11. I-FEED Post Operative Day 12

    To evaluate the efficacy of oral ORE-001 compared to placebo in reducing the gastrointestinal disturbance/intolerance and the occurrence of postoperative ileus (POI) in patients after longitudinal laparotomy defined by scoring of the postoperative I-FEED scores at POD12. The I-FEED score ranges from 0 to 14. The higher the score the more severe are the symptoms.

    Measured: Post Operative Day 12

  12. Number of participants with treatment-related adverse events

    To evaluate the safety and tolerability of oral ORE-001 in comparison to placebo in patients after longitudinal laparotomy at Baseline and up to POD9 (with possible extension to POD13).

    Measured: Post Operative Day 1-13

Timeline

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

  1. First posted28 Jun 2023
  2. Study start11 Jan 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a multi-center, randomized, double blind, placebo-controlled, phase 2 pilot efficacy study.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05923086
Sponsor's protocol ID
CT-2022-503113-31
Acronym
ORE001PIIPOI
Status last verified
Sep 2024
First submitted
9 Jun 2023
Last updated
3 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ORE001 in people with Ileus Postoperative, run by Orexa BV at 3 sites in Germany.

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 16 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 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ard Peeters, Prof. (0652383983, ardpeeters@orexa.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

I-FEED Post Operative Day 3 (time frame: Post Operative Day 3). 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 NCT05923086.

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 3 Oct 2024.

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