Counterpain PXM Versus Diclofenac Versus Piroxicam

Sponsored by Taisho Pharmaceutical Indonesia

About this trial

Last updated 2 months ago

Study ID

CT_CTPPXM001_PRT_V003/IX/2025

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

Accepting

18 to 60 Years

All Sexes

Trial Timing

Ended 3 months ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

* Outpatient in a health care setting.

* Between the ages of 18 - 60 years of either sex.

* Patients diagnosed with musculoskeletal pain as described in the target population.

* Patient can read and understand how to fill out the assessment form and diary.

* Patients gave written consent to participate in the study independently.

Exclusion Criteria

* Patient who has osteoarthritis with Grade IV Kellgren-Lawrence (KL) grading. - - Patients who underwent any of the following treatments:

* Paracentesis and drainage of joint

* Intraarticular injection (joint protection agents, local anesthetic, etc.)

* Nerve block (including trigger points)

* Patients are being treated with an analgesic opioids for their musculosceletal pain.

* Patients being treated with anti coagulant therapy such as warfarin, clopidogrel.

* Patients being treated with oral corticosteroids 3 days before and until signed the informed consent.

* Patients being treated using rigid orthoses those requiring such treatment

* Patients with neuropsychiatric disorders including depression, dementia, schizophrenia, and anxiety neurosis

* Patients with Grade 3 hypertension (systolic blood pressure ≥ 180 mmHg and diastolic blood pressure ≥ 110 mmHg regardless of the use of an antihypertensive drugs)

* Patients with acute peptic ulcer

* Patients with bronchial asthma with current or previous aspirin-induced asthma (asthmatic attacks induced by NSAIDs and other relevant drugs)

* Patients with a history of hypersensitivity or allergy to NSAIDs

* Patients with serious hepatic disease, renal disease, cardiac disease, hematologic disease, or malignancy

* Patients with a history of dermatitis requiring treatment with topical agents

* Patients with dermatitis or wounds at the application site of the study drug

* Pregnant women ,women who may be pregnant, women who wish to become pregnant during the study, or nursing women

* Patients considered by the Investigator to be inappropriate as participants of this study