Efficacy of oral lidocaine in preventing gastrointestinal disturbance in patients after abdominal surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Orexa B.V.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

19 Dec 2023 → 24 Jun 2025

Decision date (initial)

2023-09-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Orexa B.V.

External identifiers

EU CT number

2022-503113-31-01

ClinicalTrials.gov

NCT05923086

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 2

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, POD2 and from POD4 at each scheduled time point up to POD8 (with possible extension to POD12).
2. 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).

Conditions and MedDRA coding

longitudinal laparotomy

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patient must be able to understand the requirements of the study and give written informed consent prior to study start.
2. Female patients aged between 18 and 79 years (both inclusive).
3. Gynecologic surgery performed completely by longitudinal laparotomy.
4. Patient with ECOG Performance status up to 1.
5. Patient is highly likely to comply with the protocol and complete the study.
6. Patient agrees to be scheduled for peridural catheter (PDC).

Exclusion criteria 15

1. Patient has a history of gastrectomy, total colectomy, stoma creation, short bowel syndrome.
2. Clinically significant (at the discretion of the Investigator) abnormal ECG.
3. 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).
4. 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.
5. Experimental agent within 30 days or ten half-lives, whichever is longer, prior to study medication administration.
6. Pregnancy or planning to become pregnant or nursing during the study.
7. Any other condition, which in the opinion of the Investigator precludes the patient’s participation in the study.
8. Patients with close affiliation with the Investigator or persons working at the respective study sites or patients who are an employee of the Sponsor.
9. Patient has pre-operative ileus.
10. Patient is taking opioid analgesics longer than two post-operative days, exceeding a dosing of 35 mg morphine equivalent per day.
11. Chemotherapy treatment within 10 days after longitudinal surgery.
12. Any contraindication as per summary of product characteristic for the usage of local anesthetics for PDC.
13. History of uncontrolled (at the discretion of the Investigator) cardiovascular, renal, hepatic and/or liver failure.
14. History of severe allergic or anaphylactic reactions, especially to local anesthetics.
15. Clinically significant (at the discretion of the Investigator) deviation from the normal laboratory values.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. I-FEED score at POD3

Secondary endpoints 11

1. I-FEED score at POD1, POD2 and from POD4 at each scheduled time point up to POD8 (with possible extension to POD12)
2. Mean duration patients reach an I-FEED score of 0-2 (in days)
3. Mean duration patients reach increased I-FEED score > 2 (in days)
4. Change of I-FEED scores at each scheduled timepoint
5. Treatment Emergent Adverse Events (TEAEs) up to EOS (continuous)
6. Treatment Emergent Serious Adverse Events (TESAEs) up to EOS (continuous)
7. Change from Baseline to each scheduled time point up to EOS for Vital signs
8. Change from Baseline to each scheduled time point up to Day after last study drug administration for ECG
9. Change from Baseline to each scheduled time point up to Day of last study drug administration for routine laboratory tests and urine analysis
10. Change from Baseline to Day after last study drug administration for Physical examination
11. Treatment-emergent AEs leading to premature discontinuation of study drug.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Orexa B.V.

Sponsor organisation

Orexa B.V.

Address

Berghemseweg 8

City

Herpen

Postcode

5373 KH

Country

Netherlands

Scientific contact point

Organisation

Orexa B.V.

Contact name

Prof. Dr. Ard BWMM Peeters (CSO)

Public contact point

Organisation

Orexa B.V.

Contact name

Prof. Dr. Ard BWMM Peeters (CSO)

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications