Counterpain PXM Versus Diclofenac Versus Piroxicam (NCT07475663) | Clinical Trial Compass
CompletedPhase 3
Counterpain PXM Versus Diclofenac Versus Piroxicam
Indonesia180 participantsStarted 2025-11-04
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 histor…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary end-point is the difference of musculoskeletal pain reduction > 3 scores , of the response to treatment that can be seen through Brief Pain Inventory (BPI) scores.
Timeframe: From enrollment to the end of treatment at 4 months