Actively Recruiting
A Multi-center, Randomized, Double Blind, Placebo-controlled, Phase 2 Study to Investigate the Efficacy of ORE-001 in Preventing Gastrointestinal Disturbance in Patients After Longitudinal Laparotomy
Led by Orexa BV · Updated on 2024-10-03
126
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Orexa BV
Lead Sponsor
Q
QPS Holdings LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of ORE-001 in preventing gastrointestinal disturbances in female patients undergoing gynecologic surgery through longitudinal laparotomy. This multi-center, randomized, double-blind, placebo-controlled phase 2 pilot study plans to enroll up to 126 women aged 18 to 75 years. The study is designed to assess the impact of the treatment on postoperative gastrointestinal function and patient quality of life. Participants will be randomly assigned to receive either ORE-001 or a placebo. Starting from the first day after surgery (Post Operative Day 1), patients will take four 100 mg tablets of the study drug or placebo orally before their main meal each day. The treatment and assessments will continue through up to 12 days post-surgery, with ongoing monitoring of safety and treatment effects. During the study, participants will undergo clinical assessments using the I-FEED score and visual analogue scale for abdominal pain from Post Operative Day 1 through Day 8 or up to Day 12 if extended. Quality of life will be evaluated using the SF-36 questionnaire at various points. Safety tests will include vital signs, body weight, ECGs, blood and urine lab work, and pregnancy tests for women of childbearing potential. Adverse events and medication use will be recorded continuously until the study ends.
CONDITIONS
Brief Title
Preventing Gastrointestinal Disturbance in Patients After Longitudinal Laparotomy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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).
You will not qualify if you...
- 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 cardiovascular, renal and/or hepatic failure.
- History of severe allergic or anaphylactic reactions, especially to local anesthetics.
- Clinically significant deviation from the normal laboratory values.
- Clinically significant abnormal ECG.
- Intake of any class 1B antiarrhythmic drugs if used for antiarrhythmic purpose and of any class 3 antiarrhythmic drugs.
- Significant symptomatic, viral, bacterial, or fungal infection 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 that precludes participation in the study.
- Patients with close affiliation with the Investigator or Sponsor employees.
AI-Screening
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Your Study Journey
Duration - Up to 4 weeks before planned surgery
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From surgery through Post Operative Day 1
Participants undergo longitudinal laparotomy surgery and receive the study drug starting from Post Operative Day 1.
1 visit (in-person) on surgery day and POD1 assessments
Duration - From Post Operative Day 1 up to Post Operative Day 12
Participants take the study drug (ORE-001 or placebo) daily before lunch starting on Post Operative Day 1.
Daily dosing and clinical assessments from POD1 to POD8 (or up to POD12 if extended)
Duration - Up to Post Operative Day 12 and follow-up visit
Participants complete quality of life questionnaires and safety assessments after treatment ends.
1 follow-up visit after treatment completion
Trial Site Locations
Total: 3 locations
1
Universitätsklinikum Bonn (UKB).
Bonn, Germany
Actively Recruiting
2
Kaiserswerther Diakonie Florence-Nightingale- Krankenhaus
Düsseldorf, Germany, 40489
Actively Recruiting
3
Klinikum Wolfsburg
Wolfsburg, Germany, 38440
Actively Recruiting
Research Team
A
Ard Peeters, Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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