Ileus Postoperative Clinical Trial
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.
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. ;