Overview
Sponsor-declared trial summary
uncomplicated acute appendicitis
To perform a study of pain syndrome and clinical-biochemical parameters in 7 to 18 years old children with uncomplicated acute appendicitis in non-surgical treatment and develop an analgesic algorithm based on the obtained data.
Key facts
- Sponsor
- Riga Stradins University
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2025-01-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-520964-16-00
- EudraCT number
- 2021-001400-16
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To perform a study of pain syndrome and clinical-biochemical
parameters in 7 to 18 years old children with uncomplicated acute
appendicitis in non-surgical treatment and develop an analgesic
algorithm based on the obtained data.
Conditions and MedDRA coding
uncomplicated acute appendicitis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 7 to 18 years old children with first time diagnosed uncomplicated acute appendicitis who received non-surgical treatment.
Exclusion criteria 1
- Psychomotor retardation of any degree; Any inherited or acquired immunodeficiency; Any abdominal surgery in medical history; Neurological deficit of any degree; Any endocrine disease; NSAID use within 3 hours; Chronic pain requiring daily analgesic use; History of gastrointestinal bleeding, peptic or duodenal ulcer disease or inflammatory bowel disease, coagulation disorders, prior cerebrovascular bleeding, known arterio-vascular malformations; History of chronic and active renal disease, excluding renal calculi and urinary tract infections; History of chronic and active hepatocellular disease (excludes biliary stones, cholangitis or biliary duct pathology); Known hypersensitivity to ketorolac (or it's component) or other NSAID; Absence of a parent/guardian for children who are < 14 years in age.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Number of patients consented from total approached; Number of patients who completed pain assessment and treatment at all time points (totally for 3 days (72 hours));
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
KETOROLAC-GRINDEKS 30 mg/ml šķīdums injekcijām
PRD320581 · Product
- Active substance
- Ketorolac Trometamol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 90 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- M01AB15 — KETOROLAC
- Marketing authorisation
- 07-0240
- MA holder
- GRINDEKS
- MA country
- Latvia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Riga Stradins University
- Sponsor organisation
- Riga Stradins University
- Address
- Dzirciema Iela 16
- City
- Riga
- Postcode
- 1007
- Country
- Latvia
Scientific contact point
- Organisation
- Riga Stradins University
- Contact name
- BKUS
Public contact point
- Organisation
- Riga Stradins University
- Contact name
- BKUS
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Latvia | Authorised, recruitment pending | 120 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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) | Protokols11 | 1 |
| Recruitment arrangements (for publication) | Not applicable for transition trials | 1 |
| Subject information and informed consent form (for publication) | JBormotovs_petijuma_piekrisanas_forma_lab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 2006050321_08-06-2023 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-30 | Latvia | Acceptable 2025-01-30
|
2025-01-30 |