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Recruiting NCT05923086

Preventing Gastrointestinal Disturbance in Patients After Longitudinal Laparotomy.

Phase II Interventional Ileus Postoperative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ORE001, Placebo.
Who it may be relevant to
Registry conditions: Ileus Postoperative. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

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.

Interventions

  • Drug ORE001
    Administration before major meal
  • Drug Placebo
    Administration before major meal

Primary outcome measures

  • I-FEED Post Operative Day 3 [Time frame: Post Operative Day 3]
Secondary outcome measures (12)
  • I-FEED Post Operative Day 1 [Time frame: Post Operative Day 1]
  • I-FEED Post Operative Day 2 [Time frame: Post Operative Day 2]
  • I-FEED Post Operative Day 4 [Time frame: Post Operative Day 4]
  • I-FEED Post Operative Day 5 [Time frame: Post Operative Day 5]
  • I-FEED Post Operative Day 6 [Time frame: Post Operative Day 6]
  • I-FEED Post Operative Day 7 [Time frame: Post Operative Day 7]
  • I-FEED Post Operative Day 8 [Time frame: Post Operative Day 8]
  • I-FEED Post Operative Day 9 [Time frame: Post Operative Day 9]
  • I-FEED Post Operative Day 10 [Time frame: Post Operative Day 10]
  • I-FEED Post Operative Day 11 [Time frame: Post Operative Day 11]
  • I-FEED Post Operative Day 12 [Time frame: Post Operative Day 12]
  • Number of participants with treatment-related adverse events [Time frame: Post Operative Day 1-13]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Germany · 3 centers
  • Universitätsklinikum Bonn (UKB). — Bonn
  • Kaiserswerther Diakonie Florence-Nightingale- Krankenhaus — Düsseldorf
  • Klinikum Wolfsburg — Wolfsburg

Identifiers

NCT: NCT05923086 · CT-2022-503113-31

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗