Overview
Sponsor-declared trial summary
Incidence of reappearance of the muscle relaxation after reversal with neostigmine
To find the incidence of reappearance of nondepolarizing neuromuscularblock after reversal with neostigmine.
Key facts
- Sponsor
- Pirkanmaan hyvinvointialue
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 1 Jan 2025 → ongoing
- Decision date (initial)
- 2024-09-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517831-28-00
- EudraCT number
- 2019-000561-20
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
To find the incidence of reappearance of nondepolarizing neuromuscularblock after reversal with neostigmine.
Conditions and MedDRA coding
Incidence of reappearance of the muscle relaxation after reversal with neostigmine
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- To find the incidence of reappearance of nondepolarizing neuromuscular block after reversal with neostigmine.
- Body Mass Index (BMI) <35k9/ mz
- AGE 18-65 years
- ASA risk class 1-2
Exclusion criteria 2
- Disease or previous injury of central nervous system
- Disease or medication affecting peripheral nervous system
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To find the incidence of reappearance of nondepolarizing neuromuscular block after reversal with neostigmine
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
GLYCOSTIGMIN -injektioneste, liuos
PRD373810 · Product
- Active substance
- Glycopyrronium Bromide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N07AA51 — NEOSTIGMINE, COMBINATIONS
- Marketing authorisation
- 10970
- MA holder
- TAKEDA OY
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pirkanmaan hyvinvointialue
- Sponsor organisation
- Pirkanmaan hyvinvointialue
- Address
- Elamanaukio 2
- City
- Tampere
- Postcode
- 33520
- Country
- Finland
Scientific contact point
- Organisation
- Pirkanmaan hyvinvointialue
- Contact name
- Maija-Liisa Kalliomäki
Public contact point
- Organisation
- Pirkanmaan hyvinvointialue
- Contact name
- Maija-Liisa Kalliomäki
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 120 | 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 |
|---|---|---|---|---|---|
| Finland | 2025-01-01 | 2025-01-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Tutkimussuunnitelma | 1.2 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | 2019-06-14_Suostumus | 1 |
| Subject information and informed consent form (for publication) | 2023-11-12_Tiedote | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC_Glycostigmiini | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-05 | Finland | Acceptable with conditions 2024-09-17
|
2024-09-17 |