In short
Clinical trials are investigating Ibuprofen Arginine in people with moderate to severe pain after dental surgery. The studies look at how well it works, how safe it is, and how it compares with placebo and active treatments. The target group is mainly adults with pain after tooth extraction, especially third molar surgery.
Key points
- Clinical trials of Ibuprofen Arginine are focused on pain relief after dental surgery, especially after third molar extraction. The main study is a Phase 3 trial with 346 participants. It compares a combination of Ibuprofen Arginine and tramadol HCl against each active component alone and against placebo. The trial looks at both pain relief and safety. The main endpoint is pain change over the first 12 hours, measured with the Visual Analogue Scale and SPID0-12h. The target population is people with moderate to severe pain after dental extraction.
Trial overview
The clinical trial with NCT ID 2024-517807-35-00 is a randomised, double-blind, placebo-controlled, and active-treatment study in patients with moderate to severe pain after dental surgery. It is a Phase 3 interventional trial with 346 participants and it is marked as completed.
The study title says it assesses the analgesic efficacy, which means how well the treatment reduces pain, and the safety of an oral combination of Ibuprofen Arginine and tramadol HCl after dental surgery.
Study design and comparisons
This trial compares several study groups: Espididol 400 mg granules for oral solution, Adolonta 100 mg/ml oral solution, placebo granules, the oral combination of Ibuprofen (arginine)/Tramadol HCl 400/37.5 mg granules for oral solution, and placebo oral solution.
The brief summary says the main question is whether the combination gives better pain relief than the two active components used alone and compared with placebo.
Because the study is double-blind, neither the patient nor the study team knows which treatment is given during the trial, which helps reduce bias, meaning less chance that expectations affect the results.
Who the trial is for
The target population is patients with moderate to severe somatic pain after dental extraction, especially after removal of third molars, which are the back wisdom teeth. In simple terms, the study is for people who have strong pain after this type of oral surgery.
The available data do not list broader inclusion details, so the main patient group we can identify is adults with post-surgical dental pain.
What the trial measures
The primary outcome is SPID0-12h, which stands for the sum of pain intensity differences from the start of treatment until 12 hours later. This outcome is measured using the Visual Analogue Scale (VAS), a simple pain score that shows how strong pain feels.
This endpoint is important because it shows not just whether pain goes down, but how much relief patients get over time during the first 12 hours after treatment starts.
What the results mean for patients
This study is focused on short-term pain control after dental surgery, not on long-term treatment. The trial design helps researchers compare the combination treatment with single medicines and placebo in a controlled way.
For patients, the most relevant point is that the study looks at whether the combination can provide better early pain relief after tooth extraction than the comparison treatments.