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Ibuprofen Arginine

Clinical trials are investigating Ibuprofen Arginine in people with moderate to severe pain after dental surgery. These studies look at whether it helps reduce pain and whether it is safe and effective, often by comparing it with placebo or other treatments.

Table of contents

Trial overview

The available clinical trial for Ibuprofen Arginine studied patients with moderate to severe somatic pain after dental surgery, especially after extraction of third molars (wisdom teeth).[1] The study was a Phase 3 interventional trial and it was completed with 346 enrolled participants.[1]

Study design and comparison groups

This trial was described as randomised, double-blind, placebo-controlled, and active-treatment, which means patients were assigned by chance to groups and neither patients nor researchers knew the assignment during the study.[1] The study compared an oral combination of ibuprofen (arginine) and tramadol HCl 400/37.5 mg with the active components given alone and with placebo groups.[1]

The oral treatments listed in the trial data included Espididol 400 mg granulado para solución oral sabor menta, Adolonta 100 mg/ml solución oral, placebo granules for oral solution, the fixed combination of ibuprofen (arginine)/tramadol HCl 400/37.5 mg granules for oral solution, and placebo oral solution.[1]

Who participated

The study focused on people with pain after dental extraction, and the brief summary specifically mentions third molar extraction.[1] This means the target population was adults or other eligible patients who had moderate to severe pain after this type of dental surgery, according to the study rules.[1]

What was measured

The main endpoint was SPID0-12h, which means the sum of pain intensity differences from the start of treatment until 12 hours later.[1] Pain was measured using the Visual Analogue Scale (VAS), a simple tool where patients show how strong their pain is on a line or scale.[1]

The trial aimed to see whether the combination treatment gave better pain relief than the single active ingredients used alone and than placebo.[1] In simple terms, the study asked whether the combination controlled pain better over the first 12 hours after treatment.[1]

What the trial helps answer

This study helps show whether Ibuprofen Arginine, when used in a fixed oral combination with tramadol HCl, can improve short-term pain control after dental surgery.[1] Because it included placebo and active-treatment comparisons, it can help researchers judge both how well the treatment works and how it performs against other options in a real trial setting.[1]

The current trial data do not provide results, so the main value of the record is in showing the research question, the patient group, the trial phase, and the outcome measures used.[1]

Trial ID Phase Condition studied Status Enrollment
2024-517807-35-00 Phase 3 Moderate to severe somatic pain after dental surgery Completed 346

FAQ

  • Who can take part in clinical trials of Ibuprofen Arginine? The trial data provided focus on patients with moderate to severe pain after dental surgery, especially after third molar extraction. People who match that condition may be eligible, depending on the study rules.
  • What is being studied in these trials? The main question is whether Ibuprofen Arginine, used in a fixed oral combination with tramadol HCl, gives better pain relief than the active ingredients used alone or placebo. The study also looks at safety.
  • What phase is the trial? The trial provided is a Phase 3 study. Phase 3 trials usually compare a treatment with other options in a larger group of patients.
  • What condition is being studied? The study is for moderate to severe somatic pain after dental surgery. The brief summary specifically mentions pain after dental extraction, including third molars.
  • What outcome is the trial measuring? The main outcome is SPID0-12h, which means the sum of pain intensity differences over 12 hours. Pain is measured with the Visual Analogue Scale, a simple line or scale patients use to show how strong their pain is.

Sperimentazioni cliniche in corso su Ibuprofen Arginine

  • Studio sull’efficacia analgesica di ibuprofene arginina e tramadolo cloridrato per il dolore moderato-severo post-chirurgia dentale

    Arruolamento concluso

    1 1 1
    Farmaci in studio:
    Spagna

Glossario

  • Clinical trial: A research study in people that tests whether a treatment works and whether it is safe.
  • Interventional study: A study where researchers give a treatment or compare treatments to see what happens.
  • Phase 3: A later stage of testing, usually with more patients, to compare how well a treatment works and to collect more safety information.
  • Placebo: A look-alike treatment with no active medicine, used to compare results fairly.
  • Active-treatment: A comparison group that receives another real treatment instead of placebo.
  • Randomised: Patients are assigned by chance to different study groups, which helps make the comparison fair.
  • Double-blind: Neither the patient nor the study team knows which treatment the patient receives during the trial.
  • Visual Analogue Scale (VAS): A pain scale used by patients to show how strong their pain is, often on a line from no pain to worst pain.
  • SPID0-12h: A measure that adds up changes in pain from the start of treatment to 12 hours later. It helps show how much pain relief a treatment gives over time.
  • Third molar extraction: Removal of wisdom teeth, which can cause pain after surgery.

Riferimenti

  1. https://clinicaltrials.gov/study/2024-517807-35-00