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New treatment option for Ileus Postoperative
Official title Preventing Gastrointestinal Disturbance in Patients After Longitudinal Laparotomy.
ClinicalTrials.gov ID: NCT05923086
What this study is testing
What is ORE001?
ORE001 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ileus postoperative.
Also referred to as Lidocaine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multi-center, randomized, double blind, placebo-controlled, phase 2 pilot efficacy study.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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).
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bonn, Germany
- Düsseldorf, Germany
- Wolfsburg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bonn, Germany; Düsseldorf, Germany; Wolfsburg, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.