Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
192
Countries
1
Sites
1
Acute pain in pediatric age
Evaluation of non-inferiority in the speed of action of lysin ibuprofen suspension versus ibuprofen suspension in the treatment of acute pain in children.
Key facts
- Sponsor
- Dicofarm S.p.A.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- completed 4 Sep 2024
- Decision date (initial)
- 2024-01-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Dicofarm SpA
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
Evaluation of non-inferiority in the speed of action of lysin ibuprofen suspension versus ibuprofen suspension in the treatment of acute pain in children.
Secondary objectives 1
- 1. Evaluation of the efficacy of lysin ibuprofen suspension versus ibuprofen suspension on the treatment of acute pain in children. 2. Evaluation of eventual superiority of lysin ibuprofen suspension versus ibuprofen suspension on the treatment of acute pain in children. 3. Evaluation of safety of lysin ibuprofen versus ibuprofen on the treatment of acute pain in children.
Conditions and MedDRA coding
Acute pain in pediatric age
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | HLT | 10068757 | Musculoskeletal and connective tissue pain and discomfort | 10028395 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Randomized, single blind, non-inferiority study on the speed of action of lysin ibuprofen suspension Randomized, interventional, controlled, phase IV single blind study, parallel assignment, two armed, to
evaluate the speed of action and efficacy of lysin ibuprofen suspension vs not lysin ibuprofen suspension on
the treatment of acute pain in children. Subjects from 4 up to 12 years old, that will be admitted to the PER
with acute pain as a primary symptom or an accompanying symptom (sore throat, headache, ear pain,
toothache, post-traumatic musculoskeletal pain), pain intensity ≥4 in a 10 points scale that meet the
inclusion/exclusion criteria will be enrolled.
|
Randomised Controlled | Single | [{"id":32596,"code":1,"name":"Subject"}] |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Male and female pediatric subjects from ≥4 ≤12 years old.. 2. Subjects admitted to ER with acute pain as a primary symptom or an accompanying symptom (sore throat, headache, ear pain, toothache, post-traumatic musculoskeletal pain). 3. Pain intensity ≥4, assessed with validated age-related scale of 10 points. 4. Written informed consent provided by parents/tutor, willing and able to understand the purpose of the study, including possible risks and side effects, and willing and able to comply, on their behalf and of the minor, with the study requirements. 5. Willing and able to give additional written informed consent by itself, in case of children and adolescents, in addition to parents/tutor. 6. Willing and able, in case of children and adolescents, to comply with the study requirements on their behalf.
Exclusion criteria 1
- 1. Subjects with hypersensitivity to ibuprofen, or to one of the components of IMP, or any other NSAID. 2. Chicken pox. 3. Dehydration. 4. Gastroenteritis. 5. Renal failure. 6. Thrombocytopenia, coagulopathies, and haemorrhagic diathesis. 7. A history of gastrointestinal bleeding or perforation related to previous drug treatments non-steroidal anti-inflammatory drugs (NSAIDs). 8. Peptic ulcer, active or recurrent gastrointestinal bleeding (two or more separate episodes occurring on ulceration or haemorrhage). 9. Severe heart failure (NYHA: class IV). 10. Severe liver failure. 11. Patients with hereditary fructose intolerance. 12. Wheat allergy. 13. Head and abdominal trauma. 14. The analgesic pain/ anti-inflammatory has already been administered at home (paracetamol in the previous 4 hours or ibuprofen in the previous 6 hours). 15. Subjects affected by delayed psychomotor development. 16. Vomiting after drug administration (drop out). 17. Participation in any other clinical study within the 3 months prior to the screening. 18. Pregnancy.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Non inferiority of speed of action of lysin ibuprofen suspension on pain intensity measured by validated agerelated scale (Wong-Baker Faces Pain scale and Numerical Rating Scale). The reduction of pain (abbreviated PAR, from pain relief) will be assessed at different time points on the difference in the values of the pain scales used. The main assessment is at five minutes timepoint.
Secondary endpoints 1
- 1. Evaluation of PAR general score after 10 , 20 and 30 minutes. 2. Evaluation of AEs/SAEs.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
ALGIDRIN 20 mg/ml sospensione orale, Bambini
PRD8757990 · Product
- Active substance
- Ibuprofen Lysine
- Pharmaceutical form
- ORAL SUSPENSION
- Route of administration
- ORAL
- Max daily dose
- 20 mg/kg milligram(s)/kilogram
- Max total dose
- 20 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M01AE01 — IBUPROFEN
- Marketing authorisation
- 049108020
- MA holder
- DICOFARM S.P.A.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 2
MOMENTKID bambini 100 mg/5 ml sospensione orale
PRD513857 · Product
- Active substance
- Ibuprofen
- Pharmaceutical form
- ORAL SUSPENSION
- Route of administration
- ORAL
- Max daily dose
- 20 mg/Kg milligram(s)/kilogram
- Max total dose
- 20 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M01AE01 — IBUPROFEN
- Marketing authorisation
- 038666018
- MA holder
- AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
NUROFEN FEBBRE E DOLORE Bambini 100mg/5ml sospensione orale gusto arancia senza zucchero
PRD3039960 · Product
- Active substance
- Ibuprofen
- Pharmaceutical form
- ORAL SUSPENSION
- Route of administration
- ORAL
- Max daily dose
- 20 mg/kg milligram(s)/kilogram
- Max total dose
- 20 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M01AE01 — IBUPROFEN
- Marketing authorisation
- 034102020
- MA holder
- RECKITT BENCKISER HEALTHCARE (ITALIA) SPA
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Dicofarm S.p.A.
- Sponsor organisation
- Dicofarm S.p.A.
- Address
- Via Del Casale Della Marcigliana 29
- City
- Rome
- Postcode
- 00138
- Country
- Italy
Scientific contact point
- Organisation
- Dicofarm S.p.A.
- Contact name
- Diana Diofebi
Public contact point
- Organisation
- Dicofarm S.p.A.
- Contact name
- Diana Diofebi
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 192 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-12 | Italy | Acceptable 2024-01-10
|
2024-01-11 |