Counterpain PXM Versus Diclofenac Versus Piroxicam

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.

Conditions

• Ankle Sprain
• Back Pain
• Osteoarthritis (OA) of the Knee
• Tennis Elbow
• Runner's Knee

Interventions

DRUG

Piroxicam plus Counterirritant (brand name Counterpain® PXM).

Participants assigned to this intervention group will use Piroxicam plus Counterirritant gel (Counterpain® PXM) . Each application involves dispensing approximately 1 gram (3 cm) of gel onto a provided dosing card and applying it directly to the painful area. The gel contains 0.5% Piroxicam as the anti-inflammatory agent, combined with three counterirritants: Methyl Salicylate, Menthol, and Eugenol. These counterirritants produce distinct warming and cooling sensations upon application. Participants will apply the gel three times daily (morning, afternoon, evening) for 6 ± 1 days. The total number of applications and the timing of the perceived thermal sensation will be recorded in a participant diary. This intervention is distinct from the comparator arms (Piroxicam-only and Diclofenac gels) specifically due to the presence of these counterirritant ingredients, which are intended to provide additional symptomatic relief through sensory stimulation.

DRUG

Diclofenac Sodium 10 mg (Brand Name Hotin® DCL)

Dose : Refer to the product's leaflet : no occlusive dress should be employed. Apply the required amount of cream on the affected area three times a day and rub gently. The amount of cream needed depends on the extent of the painful area. The affected area are : * In the arms: hand, wrist, elbow, shoulder sinistra or dextra * In the legs: feet, ankle, knee sinistra or dextra * Upper back or Lower back 3 times daily means : * application one time in morning (06.00 - 11.00), o one time in afternoon (11.01 - 17.00), * one time in evening (17.01 - 23.00). Aplication of gel will use dosing card that provided in this clinical study. * Method of administration: external use only. * Every visit, participants will get 2 tubes and in total are 6 tubes for 6 + 1 days application

DRUG

Piroxicam 0.5% (Brand name Pirofel® gel)

Dose: Apply gel to the affected area three times daily leaving no residual material on the skin. 1 gram of gel applied to the affected area. The affected area are : * In the arms: hand, wrist, elbow, shoulder sinistra or dextra * In the legs: feet, ankle, knee sinistra or dextra * Upper back or Lower back 3 times daily means : * application one time in morning (06.00 - 11.00) * one time in afternoon (11.01 - 17.00), * one time in evening (17.01 - 23.00). Aplication of gel will use dosing card that provided in this clinical study. * Method of administration: external use only. * Every visit, participants will get 2 tubes and in total are 6 tubes for 6 + 1 days application.

Sponsors & Collaborators

• Taisho Pharmaceutical Indonesia

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-04

Primary Completion

2026-02-12

Completion

2026-02-12

Countries

• Indonesia

Study Locations