Clinical trial • Phase IV • Gastroenterology
APREPITANT for Postoperative nausea and vomiting
Phase IV trial of APREPITANT for Postoperative nausea and vomiting.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Postoperative nausea and vomiting
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 23-12-2023
- First CTIS Authorization Date
- 02-04-2024
Trial design
Randomised, aprepitant arm: patients receiving 80 mg of aprepitant (oral) 2 hours prior to surgery. placebo arm: patient receiving placebo (platseebo 80mg hard gelatin capsule produced by east tallinn-central hospital pharmacy).-controlled Phase IV trial across 1 site in Estonia.
- Randomised
- Yes
- Comparator
- Aprepitant arm: Patients receiving 80 mg of Aprepitant (oral) 2 hours prior to surgery. Placebo arm: Patient receiving placebo (Platseebo 80mg hard gelatin capsule produced by East Tallinn-Central Hospital Pharmacy).
- Target Sample Size
- 260
Eligibility
Recruits 260 No vulnerable populations selected; participants are adults (18 years or older); consent to be provided by adult participants..
- Vulnerable Population
- No vulnerable populations selected; participants are adults (18 years or older); consent to be provided by adult participants.
Inclusion criteria
- {"criterion_text":"- Patient is scheduled for bariatric surgery - LSG (laparoscopic sleeve gastrectomy),RYGB(Roux-en-Y) or OAGB(one-anastomosis MINI gastric bypass).\n- Patients are adult - 18 years or older.\n- Patients have at least 2 risk factors for PONV - female sex, non-smokers, post-operative opioid analgesia, previous PONV and a duration of surgery longer than 1 hour.\n- Obesity with a BMI more than 30."}
Exclusion criteria
- {"criterion_text":"- Revision bariatric surgery.\n- Known intolerance to the study drug - aprepitant."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence of PONV","definition_or_measurement_approach":"Incidence measured as occurrence of postoperative nausea and vomiting (no further definition provided)."}
- {"endpoint_text":"- Severity of PONV measured by NRS (numeric rate scale) and Rhodes scale","definition_or_measurement_approach":"Severity measured using NRS (numeric rate scale) and Rhodes scale as stated."}
- {"endpoint_text":"- Use of rescue medication, type and dose.","definition_or_measurement_approach":"Recorded use of rescue medication including type and dose (no further detail provided)."}
Secondary endpoints
- {"endpoint_text":"- Correlation between intraabdominal pressure during surgery and PONV incidence and severity.","definition_or_measurement_approach":"Correlation analysis between recorded intraabdominal pressure during surgery and PONV incidence/severity (no further detail provided)."}
- {"endpoint_text":"- Length of stay in recovery room","definition_or_measurement_approach":"Measured duration of recovery room stay (no further detail provided)."}
- {"endpoint_text":"- Length of hospital stay","definition_or_measurement_approach":"Measured duration of hospitalisation (no further detail provided)."}
- {"endpoint_text":"- Subjective patient satisfaction assessment NRS (1-10) of postoperative period.","definition_or_measurement_approach":"Patient satisfaction assessed by NRS scale 1-10 as stated."}
Recruitment
- Planned Sample Size
- 260
- Recruitment Window Months
- 6
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 260
Estonia
- Earliest CTIS Part Ii Submission Date
- 24-03-2024
- Latest Decision Or Authorization Date
- 02-04-2024
- Processing Time Days
- 9
- Number Of Sites
- 1
- Number Of Participants
- 260
Sites
- Site Name
- AS Bariatric Services
- Department Name
- Anaesthesiology
- Principal Investigator Name
- Jaanus Korjas
- Principal Investigator Email
- jaanus.korjas@ut.ee
- Contact Person Name
- Jaanus Korjas
- Contact Person Email
- jaanus.korjas@ut.ee
Sponsor
Primary sponsor
- Full Name
- University Of Tartu
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Estonia
Investigational products
- Investigational Product Name
- Aprepitant Sandoz, 125 mg, kõvakapslid + Aprepitant Sandoz, 80 mg, kõvakapslid
- Active Substance
- APREPITANT
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- oral
- Authorisation Status
- Marketing authorisation present (miaNumber 960118) in EE/HU/H/0498/003 referenced
- Starting Dose
- 80 mg
- Dose Levels
- 80 mg
- Frequency
- single dose given 2 hours prior to surgery
- Maximum Dose
- 125 mg
- Investigational Product Name
- Platseebo 80mg kõvakapsel
- Modality
- Other
- Starting Dose
- 80 mg (placebo capsule)
- Dose Levels
- 80 mg (placebo)
Related trials
Other published trials that may interest you.