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Ibuprofen Arginine

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.

Table of Contents

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.[1] It is a Phase 3 interventional trial with 346 participants and it is marked as completed.[1]

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.[1]

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.[1]

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.[1]

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.[1]

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.[1] In simple terms, the study is for people who have strong pain after this type of oral surgery.[1]

The available data do not list broader inclusion details, so the main patient group we can identify is adults with post-surgical dental pain.[1]

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.[1] This outcome is measured using the Visual Analogue Scale (VAS), a simple pain score that shows how strong pain feels.[1]

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.[1]

What the results mean for patients

This study is focused on short-term pain control after dental surgery, not on long-term treatment.[1] The trial design helps researchers compare the combination treatment with single medicines and placebo in a controlled way.[1]

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.[1]

Trial IDPhaseCondition studiedStatusEnrollment
2024-517807-35-00Phase 3Moderate to severe somatic pain after dental surgeryCompleted346

FAQ

  • What are the clinical trials about? They study whether Ibuprofen Arginine, alone or in combination with tramadol HCl, can reduce pain after dental surgery. The main focus is pain relief and safety.
  • Who can take part in these trials? The trial data describe patients with moderate to severe pain after dental extraction, especially after removal of third molars. This means the study is aimed at people recovering from this type of surgery.
  • What phase is the study? The trial is a Phase 3 study. Phase 3 trials usually test how well a treatment works in a larger group of patients and continue to monitor safety.
  • What is being compared in the trial? The study compares Ibuprofen Arginine plus tramadol HCl with the active components given alone and with placebo. Placebo means a look-alike treatment with no active medicine.
  • What outcome is the trial measuring? The main outcome is pain change over 12 hours, measured with the Visual Analogue Scale (VAS). The trial uses a score called SPID0-12h, which shows the total pain relief over time.

Ongoing Clinical Trials on Ibuprofen Arginine

  • Study on Pain Relief After Dental Surgery Using Ibuprofen Arginine and Tramadol Hydrochloride for Patients with Moderate to Severe Pain

    Not recruiting

    1 1 1
    Investigated drugs:
    Spain

Glossary

  • Analgesic efficacy: How well a treatment relieves pain.
  • Safety: How well a treatment is tolerated and whether unwanted effects are being watched for in the study.
  • Randomised: Participants are placed into study groups by chance, not by choice.
  • Double-blind: Neither the patient nor the study team knows which treatment the patient gets, which helps keep the results fair.
  • Placebo: A look-alike treatment with no active medicine. It helps researchers compare real treatment effects.
  • Active-treatment: A study group that receives a treatment known to have an effect, used for comparison.
  • Phase 3: A later stage of clinical research that studies how well a treatment works in a larger group of patients.
  • Enrollment: The number of people who joined the trial.
  • Visual Analogue Scale (VAS): A simple pain scale used to show how strong pain is.
  • SPID0-12h: A score that adds up pain relief over the first 12 hours after treatment starts.
  • Monotherapy: Treatment with one medicine only.
  • Third molars: The back teeth, also called wisdom teeth.

References

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