Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
260
Countries
1
Sites
1
Postoperative nausea and vomiting
Decrease the incidence of postoperative nausea and vomiting.
Key facts
- Sponsor
- University Of Tartu
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 11 Apr 2024 → ongoing
- Decision date (initial)
- 2024-04-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
Decrease the incidence of postoperative nausea and vomiting.
Secondary objectives 5
- Decrease PONV severity
- Decrease the use of rescue medications for PONV.
- Increase in patient satisfaction.
- Decrease the length of recovery room stay.
- Decrease in length of hospitalisation following bariatric surgery.
Conditions and MedDRA coding
Postoperative nausea and vomiting
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Period of study. Enrollment of 260 patients undergoing bariatric surgery.
|
Randomised Controlled | Double | [{"id":101927,"code":5,"name":"Carer"},{"id":101924,"code":4,"name":"Analyst"},{"id":101926,"code":1,"name":"Subject"},{"id":101925,"code":2,"name":"Investigator"}] | Aprepitant arm.: Patients receiving 80 mg of Aprepitant 2h prior to surgery. Placebo arm.: Patsient receiving placebo. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Patient is scheduled for bariatric surgery - LSG (laparoscopic sleeve gastrectomy),RYGB(Roux-en-Y) or OAGB(one-anastomosis MINI gastric bypass).
- Patients are adult - 18 years or older.
- 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.
- Obesity with a BMI more than 30.
Exclusion criteria 2
- Revision bariatric surgery.
- Known intolerance to the study drug - aprepitant.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Incidence of PONV
- Severity of PONV measured by NRS (numeric rate scale) and Rhodes scale
- Use of rescue medication, type and dose.
Secondary endpoints 4
- Correlation between intraabdominal pressure during surgery and PONV incidence and severity.
- Length of stay in recovery room
- Length of hospital stay
- Subjective patient satisfaction assessment NRS (1-10) of postoperative period.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Aprepitant Sandoz, 125 mg, kõvakapslid + Aprepitant Sandoz, 80 mg, kõvakapslid
PRD5858841 · Product
- Active substance
- Aprepitant
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 285 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- A04AD12 — -
- Marketing authorisation
- 960118
- MA holder
- SANDOZ PHARMACEUTICALS D.D.
- MA country
- Estonia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Of Tartu
- Sponsor organisation
- University Of Tartu
- Address
- Ravila Tn 19
- City
- Tartu Linn
- Postcode
- 50411
- Country
- Estonia
Scientific contact point
- Organisation
- University Of Tartu
- Contact name
- Liivi Maddison
Public contact point
- Organisation
- University Of Tartu
- Contact name
- Liivi Maddison
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Estonia | Ongoing, recruitment ended | 260 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Estonia | 2024-04-11 | 2024-04-11 | 2025-01-09 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-23 | Estonia | Acceptable 2024-04-01
|
2024-04-02 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-07 | Estonia | Acceptable 2024-04-01
|
2025-01-07 |