drugset / Trial / NCT07475663

Counterpain PXM Versus Diclofenac Versus Piroxicam

NCT07475663

Phase 3 Completed 180 enrolled Taisho Pharmaceutical Indonesia
RandomizedSingle-groupSingle-blindTreatment

Summary

The goal of this clinical trial is to learn if a gel containing Piroxicam plus Counterirritant (warming/cooling ingredients) is as effective and safe as two other common anti-inflammatory gels for treating acute muscle, bone, and joint pain in adults aged 18-60. The main questions it aims to answer are: Does the Piroxicam plus Counterirritant gel provide a similar level of pain relief as the standard Piroxicam-only gel and the Diclofenac gel? Is the Piroxicam plus Counterirritant gel as safe to use as the other two gels? Researchers will compare three groups of participants, each using one of the gels (Piroxicam plus Counterirritant, Piroxicam-only, or Diclofenac) to see if the combination gel works equally well. Participants will: * Be randomly assigned to use one of the three gels for approximately 6 days. * Visit the clinic three times (at the start, midpoint, and end) for pain assessments, physical exams (checking movement and muscle strength), and physiotherapy sessions. * Apply their assigned gel at home three times daily (morning, afternoon, evening) and record their gel use and pain levels in a provided diary. * Receive a rescue medication (paracetamol) to use only if their pain becomes unbearable and record when they take it.

Timeline

Start
2025-11-04
Primary completion
2026-02-12
Completion
2026-02-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Diclofenac Other / unclassified 10 mg Topical
Subject Menthol Small molecule Topical
Subject Methyl Salicylate Small molecule Topical
Comparator Piroxicam Unknown 0.5 % Topical
Subject eugenol Small molecule Topical