In short
This article provides information about 2 ongoing clinical trials investigating treatments for rheumatic disorders. The trials are testing different approaches, including treatment for lung complications associated with systemic autoimmune rheumatic diseases and pain management in children with acute pain symptoms that may accompany rheumatic conditions.
Clinical trial locations
- Austria
- France
- Germany
- Italy
- Netherlands
- Norway
- Spain
Study Comparing the Speed of Action of Ibuprofen Lysine and Ibuprofen in Treating Acute Pain in Children
This clinical trial focuses on comparing how quickly two different forms of ibuprofen work to relieve acute pain in children. The study compares ibuprofen lysine suspension with regular ibuprofen suspension, both commonly used to treat pain and reduce fever in children.
Main inclusion criteria:
- Children between 4 and 12 years old
- Admitted to the emergency room with acute pain as a main or accompanying symptom, including sore throat, headache, ear pain, toothache, or pain from an injury
- Pain level of 4 or higher on a 10-point scale (adjusted for age)
- Written informed consent from parents or guardians, and from the child or adolescent where applicable
- Willingness and ability to follow study requirements
Main exclusion criteria:
- Other serious health conditions that might interfere with the study
- Currently taking other medications that might affect study results
- Allergies to ibuprofen or similar medications
- History of stomach problems such as ulcers or bleeding
- Kidney or liver problems
- Asthma that is worsened by aspirin or other non-steroidal anti-inflammatory drugs
- Participation in another clinical trial
Focus and goal: The primary goal is to evaluate how quickly each medication provides pain relief, with the first assessment taking place just five minutes after administration. Additional assessments will be conducted at 10, 20, and 30 minutes to further evaluate the effectiveness. The study uses age-appropriate pain scales such as the Wong-Baker Faces Pain Scale and the Numerical Rating Scale. It is designed as a single-blind study, meaning participants do not know which medication they are receiving, to ensure unbiased results. Throughout the study, children will be monitored for any side effects.
Investigational drugs: Lysin ibuprofen suspension is a liquid form of ibuprofen with lysine added to help the medication be absorbed faster by the body, potentially leading to quicker pain relief. It is being compared to standard ibuprofen suspension, a common pain reliever and anti-inflammatory medication used to reduce fever and relieve pain from various conditions including headache, toothache, and injuries.
Summary
The two ongoing clinical trials address different aspects of conditions related to or accompanying systemic autoimmune diseases. The first trial is a multi-country study spanning seven European nations (Germany, Netherlands, Austria, France, Spain, Italy, and Norway) and focuses specifically on lung complications that can develop in people with autoimmune conditions. This represents a significant area of research, as lung involvement can be a serious complication that affects quality of life and survival in people with these conditions.
The second trial, conducted in Italy, addresses the important aspect of pain management in children, which may be relevant for pediatric patients experiencing acute pain symptoms that can accompany various conditions. Both trials demonstrate the ongoing efforts to improve treatment options, whether by developing new medications for complex lung complications or by optimizing pain relief strategies for younger patients.
The nerandomilast trial is particularly notable for its broad geographic scope and its focus on a specific complication that affects multiple autoimmune conditions, potentially benefiting a wider patient population if successful.
