Counterpain PXM Versus Diclofenac Versus Piroxicam

NCT07475663 | Completed Phase 3 DMC

• 2 other identifiers: CT_CTPPXM001_PRT_V003/IX/2025IDR 488.395.000
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (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.

  The Brief Pain Inventory (BPI) scores is a medical questionnaire that is used to assess pain. It has also been validated for pain assessment chronicle. There are 9 questions related to the pain experienced by the participants. The pain assessment will be given in the form of a score, namely a score of 0 - 10. The difference BPI scale \> 3 , from initial scale of pain to the end of treatment will be captured as the primary efficacy endpoint. The selection of difference more than equal to 3 was chosen because if the participant has moderate pain at the beginning of the treatment, then at the end of the treatment there is a decrease in pain to mild pain. This can be seen that the treatment is effective in dealing with musculoskeletal pain

  From enrollment to the end of treatment at 4 months

Study Arms (2)

PXM + Counterirritant

EXPERIMENTAL

Apply gel to the affected area three times daily leaving no residual material on the skin.1 gram of gel ( \~ 3 cm) applied to the affected area.

Drug: Piroxicam plus Counterirritant (brand name Counterpain® PXM).

Comparator Drugs

ACTIVE COMPARATOR

Apply gel to the affected area three times daily leaving no residualmaterial on the skin. 1 gram of gel ( \~ 3 cm) applied to the affected area.

Drug: Diclofenac Sodium 10 mg (Brand Name Hotin® DCL); Drug: Piroxicam 0.5% (Brand name Pirofel® gel)

Interventions

Diclofenac Sodium 10 mg (Brand Name Hotin® DCL) DRUG

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

Comparator Drugs

Piroxicam 0.5% (Brand name Pirofel® gel) DRUG

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.

Comparator Drugs

Piroxicam plus Counterirritant (brand name Counterpain® PXM). DRUG

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.

PXM + Counterirritant

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Taisho Pharmaceutical Indonesia: lead

Study Sites (1)

St. Carolus Sports Clinic & Klinik Utama Eminence

Jakarta, DKI Jakarta, 10440, Indonesia

Location

Related Publications (6)

• Derry S,Moore RA,Gaskell H,McIntyre M,Wiffen PJ

  BACKGROUND

• Kocak AO, Dogruyol S, Akbas I, Menekse TS, Gur STA, Kocak MB, Cekmen B, Orun S, Cakir Z. Comparison of topical capsaicin and topical piroxicam in the treatment of acute trauma-induced pain: A randomized double-blind trial. Am J Emerg Med. 2020 Sep;38(9):1767-1771. doi: 10.1016/j.ajem.2020.05.104. Epub 2020 Jun 2.

  PMID: 32739846 BACKGROUND

• Stratford PW, Binkley J, Solomon P, Gill C, Finch E. Assessing change over time in patients with low back pain. Phys Ther. 1994 Jun;74(6):528-33. doi: 10.1093/ptj/74.6.528.

  PMID: 8197239 BACKGROUND

• Cleland JA, Mintken PE, McDevitt A, Bieniek ML, Carpenter KJ, Kulp K, Whitman JM. Manual physical therapy and exercise versus supervised home exercise in the management of patients with inversion ankle sprain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2013;43(7):443-55. doi: 10.2519/jospt.2013.4792. Epub 2013 Apr 29.

  PMID: 23628755 BACKGROUND

• Mizner RL, Petterson SC, Snyder-Mackler L. Quadriceps strength and the time course of functional recovery after total knee arthroplasty. J Orthop Sports Phys Ther. 2005 Jul;35(7):424-36. doi: 10.2519/jospt.2005.35.7.424.

  PMID: 16108583 BACKGROUND

• McMahon SB, Dargan P, Lanas A, Wiffen P. The burden of musculoskeletal pain and the role of topical non-steroidal anti-inflammatory drugs (NSAIDs) in its treatment. Ten underpinning statements from a global pain faculty. Curr Med Res Opin. 2021 Feb;37(2):287-292. doi: 10.1080/03007995.2020.1847718. Epub 2020 Nov 20.

  PMID: 33155849 BACKGROUND

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MeSH Terms

Conditions

Ankle Injuries; Back Pain; Osteoarthritis; Tennis Elbow

Interventions

Piroxicam; Irritants; Diclofenac

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Elbow Injuries; Arm Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Specialty Uses of Chemicals; Chemical Actions and Uses; Noxae; Toxic Actions; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 16, 2026
• Study Start: November 4, 2025
• Primary Completion: February 12, 2026
• Study Completion: February 12, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

ID (1)