Table of Contents

• Trial overview
• Children with acute pain
• Other conditions studied
• Phases and who can join
• Main outcomes being measured
• What this means for patients

Trial overview

The trial data show that Ibuprofen Lysine is being studied in different research settings, mostly as one of several listed treatments in interventional trials.^{[1][2][3][4][5]}

These studies include a Phase 3 trial in children with acute pain and Phase 1/2 studies in rare metabolic conditions, plus a Phase 3 study in axial spondyloarthritis where ibuprofen is one of several NSAID options.^{[1][2][3][4][5]}

Children with acute pain

One completed Phase 3 study, called SAPed, tested the speed of action of lysin ibuprofen suspension versus ibuprofen suspension in children with acute pain.^[1]

This was a randomized, single-blind, non-inferiority study, which means the researchers compared two treatments and checked whether one was not worse than the other by more than a set margin.^[1]

The main endpoint was pain relief measured with age-based pain scales, including the Wong-Baker Faces Pain Scale and the Numerical Rating Scale, with the key time point at five minutes after treatment.^[1]

Other conditions studied

In the other trial records, Ibuprofen Lysine appears as one of the listed oral drugs used alongside study medicines in different conditions.^[2][3][4][5]

These conditions include glycogen storage disease type 1a (GSD1a), phenylketonuria, propionic acidemia, and axial spondyloarthritis.^[2][3][4][5]

For these studies, the main research focus is not described as Ibuprofen Lysine alone, but the trial records show it as part of the treatment and support medicines used during the study.^[2][3][4][5]

Phases and who can join

The studies in the data are mainly Phase 1/2 or Phase 3 trials.^{[1][2][3][4][5]}

Phase 1/2 trials in the data included participants with GSD1a, phenylketonuria, and propionic acidemia.^[2][3][4]

The Phase 3 trials included children with acute pain and adults with axial spondyloarthritis who had failed NSAID therapy in outpatient care.^[1][5]

Enrollment ranged from 54 to 192 participants in the trials provided.^{[1][2][3][4][5]}

Main outcomes being measured

The pediatric pain study measured pain intensity and the speed of pain relief using validated scales for children and older children.^[1]

The GSD1a study measured safety and tolerability through treatment-emergent adverse events, serious adverse events, and changes in vital signs, ECG results, and laboratory findings.^[2]

The phenylketonuria study focused on the number of participants with treatment-emergent adverse events.^[3]

The propionic acidemia study measured safety outcomes in Part 1 and Part 3, and in Part 2 it measured the annualized frequency of CEC-adjudicated MDEs, which means major disease events reviewed by a committee and counted over a year.^[4]

The axial spondyloarthritis study measured the proportion of patients with low disease activity, defined as ASDAS below 2.1, after 12 weeks of treatment.^[5]

What this means for patients

Based on the trial records, Ibuprofen Lysine is being studied mainly in ways that help researchers compare treatment speed, safety, and clinical benefit in specific groups.^{[1][2][3][4][5]}

The strongest direct evidence in the data is the pediatric acute pain trial, where the goal was to see how quickly pain relief started.^[1]

In the other studies, Ibuprofen Lysine is listed among study medications, while the main trial goals focus on the main disease being studied and the safety of the overall treatment plan.^[2][3][4][5]