Overview
Sponsor-declared trial summary
Pain during eye examination of premature infants.
The primary objective is to investigate whether clonidine works is a good analgesic during examination for Retinopathy of Prematurity (ROP)
Key facts
- Sponsor
- Region Oerebro Laen
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 22 Jul 2024 → ongoing
- Decision date (initial)
- 2024-07-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512438-14-00
- EudraCT number
- 2021-003005-21
- ClinicalTrials.gov
- NCT04902859
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The primary objective is to investigate whether clonidine works is a good analgesic during examination for Retinopathy of Prematurity (ROP)
Secondary objectives 3
- Change in emotional sweating Galvanic Skin Response (GSR)
- Evaluation of the safety of Clonidine in regards to AEs, SAEs and SUSARs
- Will the infant be easier to examine by the eye doctor after receiving Clonidine?
Conditions and MedDRA coding
Pain during eye examination of premature infants.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- The infant is admitted to the study clinic
- The infants guardian/s has/have given their written consent to the child's participation in the study
- The infant is born before gestation week 30
Exclusion criteria 6
- Children who has received beta blockers, pain reliever or sedating drug within 24 hours of eye examination.
- Previously documented kidney failure
- Does not have a gastric tube
- Neurologically affected
- Known cardiac arrhythmia
- Circulatory instability (defined as mean arterial pressure lower than the child's gestational age)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PIPP-R scores within 30 seconds after the eye examination has been initiated, i.e. when the hooks are in place in the first eye in Uppsala or when the first eye is held open in Örebro.
Secondary endpoints 3
- GSR: Area small peaks, area huge peaks, peaks per second och average rise time
- Number of reported AEs, SAEs and SUSARS
- A VAS scale of 0-10 cm, from very easy to examin (0) to very difficult to examin (10)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP159826 · ATC
- Active substance
- Clonidine Hydrochloride
- Substance synonyms
- N-(2,6-DICHLOROPHENYL)-4,5-DIHYDRO-1H-IMIDAZOL-2-AMINE HYDROCHLORIDE
- Route of administration
- ORAL
- Max daily dose
- 4 mg/ml milligram(s)/millilitre
- Max total dose
- 4 mg/ml milligram(s)/millilitre
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- C02AC01 — CLONIDINE
- Marketing authorisation
- -
- Paediatric formulation
- Yes
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Oerebro Laen
- Sponsor organisation
- Region Oerebro Laen
- Address
- Sodra Grev Rosengatan
- City
- Orebro
- Postcode
- 701 85
- Country
- Sweden
Scientific contact point
- Organisation
- Region Oerebro Laen
- Contact name
- Miriam Pettersson
Public contact point
- Organisation
- Region Oerebro Laen
- Contact name
- Miriam Pettersson
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 50 | 2 |
| 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 |
|---|---|---|---|---|---|
| Sweden | 2024-07-22 | 2024-07-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Studieprotokoll CloROP | 4.0 |
| Recruitment arrangements (for publication) | Placeholder - sv | 1 |
| Subject information and informed consent form (for publication) | 05-Forskningspersonsinformation-cloROP | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC Klonidin | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-08 | Sweden | Acceptable with conditions 2024-07-22
|
2024-07-22 |