Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
88
Countries
1
Sites
5
Visible esophageal lesions ((pre)cancerous)
To evaluate the efficacy of local injection of levobupivacaine during esophageal ESD for direct post-procedural pain relief (within 90 minutes after ESD).
Key facts
- Sponsor
- Sint Antonius Ziekenhuis Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Neoplasms [C04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 22 Oct 2024 → ongoing
- Decision date (initial)
- 2024-08-23
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
To evaluate the efficacy of local injection of levobupivacaine during esophageal ESD for direct post-procedural pain relief (within 90 minutes after ESD).
Secondary objectives 3
- - To evaluate the effect of local LB on severity and duration of pain in the first 14 days after the endoscopic procedure
- - To evaluate safety of administration of LB
- - To evaluate effect of LB on length of hospital stay
Conditions and MedDRA coding
Visible esophageal lesions ((pre)cancerous)
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- - Patients age ≥18 years at time of consent
- - Visible lesion in the esophagus, minimum diameter of the lesion ≥20 mm
- - Scheduled for esophageal ESD
- - Informed consent
Exclusion criteria 15
- - Presence of multiple lesions requiring two or more separate endoscopic resections
- - History of esophageal surgery other than fundoplications
- - History of esophageal ablation therapy
- - History of radiotherapy of the esophagus
- - Esophageal varices
- - Prior endoscopic resection in the same area
- - Brugada syndrome
- - Uncontrolled coagulopathy
- - Severe medical comorbidities precluding endoscopy
- - Allergy to LB or other amide-type local anaesthesia
- - Current regular use of opioids
- - Other aetiology causing pain similar to post-ESD pain
- - Pregnancy or breast feeding
- - Inability to assess pain due to severe psychiatric or neurological disease
- - Insufficient command of Dutch language
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The proportion of patients with major pain within 90 minutes after the procedure comparing the LB and non-LB group. Major pain is defined as a score of four or higher based on a 0-10 NRS. The peak pain score (maximum reported pain score) at one of the three pre-defined time points of 30, 60 and 90 minutes after the procedure will be used for this.
Secondary endpoints 7
- - Pain scores based on a 0-10 NRS within 90 minutes after the procedure, 6 hours after the procedure and thereafter daily up to day 14.
- - Cumulative pain throughout 14 days based on the area under the curve of a pain versus time plot.
- - Duration of pain, defined as the number of days until pain scores were reported to be 0 on all following days.
- - Daily and overall use of analgesics up to day 14 post-procedurally registered in a patient diary (electronic or on paper).
- - Incidence of adverse events related to LB administration (including allergic reactions to LB).
- - Incidence of serious adverse events related to LB administration (including allergic reactions to LB).
- - Length of hospital stay in days.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Levobupivacaïne Fresenius Kabi 2,5 mg/ml, oplossing voor injectie/infusie
PRD2054755 · Product
- Active substance
- Levobupivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INJECTION
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 2 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB10 — LEVOBUPIVACAINE
- Marketing authorisation
- RVG 113448
- MA holder
- FRESENIUS KABI NEDERLAND B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
Diclofenac Na CF 25 mg/ml, oplossing voor injectie
PRD515578 · Product
- Active substance
- Diclofenac Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M01AB05 — DICLOFENAC
- Marketing authorisation
- RVG 17256
- MA holder
- CENTRAFARM B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Paracetamol Fresenius Kabi 10 mg/ml oplossing voor infusie
PRD409154 · Product
- Active substance
- Paracetamol
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 4000 g gram(s)
- Max total dose
- 4000 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- RVG 105747
- MA holder
- FRESENIUS KABI NEDERLAND B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sint Antonius Ziekenhuis Stichting
- Sponsor organisation
- Sint Antonius Ziekenhuis Stichting
- Address
- Koekoekslaan 1
- City
- Nieuwegein
- Postcode
- 3435 CM
- Country
- Netherlands
Scientific contact point
- Organisation
- Sint Antonius Ziekenhuis Stichting
- Contact name
- Laura Boer
Public contact point
- Organisation
- Sint Antonius Ziekenhuis Stichting
- Contact name
- Laura Boer
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 88 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Catharina Ziekenhuis Stichting
MDL, Michelangelolaan 2, 5623 EJ, Eindhoven
Universitair Medisch Centrum Utrecht
MDL, Heidelberglaan 100, 3584 CX, Utrecht
Sint Antonius Ziekenhuis Stichting
MDL, Koekoekslaan 1, 3435 CM, Nieuwegein
Universitair Medisch Centrum Groningen
MDL, Hanzeplein 1, 9713 GZ, Groningen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
MDL, Dr. Molewaterplein 60, 3015 GJ, Rotterdam
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-10-22 | 2024-10-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-510912-66-00 without track changes | 2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Antonius Hospital without track changes | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Catharina Hospital without track changes | 2.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPc Levobupivacaine Fresenius Kabi | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS Dutch 2024-510912-66-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS English 2024-510912-66-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-25 | Netherlands | Acceptable 2024-08-23
|
2024-08-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-19 | Netherlands | Acceptable 2026-01-12
|
2026-01-16 |