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Randomized, single blind, non-inferiority study on the speed of action of lysin ibuprofen suspension vs ibuprofen suspension in the treatment of acute pain in children (SAPed).
EU CTIS ID: 2023-507510-27-00
What this study is testing
Evaluation of non-inferiority in the speed of action of lysin ibuprofen suspension versus ibuprofen suspension in the treatment of acute pain in children.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.