Efficacy & Safety of Piroxicam Plus Counterirritant Gel Compared With Other Topical Non-Steroid Anti-Inflammatory Drugs in Managing Musculoskeletal Pain: A Randomized Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
The primary goal is to demonstrate that a gel containing the active ingredients Piroxicam plus Counterirritant is equally effective and safe as two other widely used gels in reducing pain. The three gels being compared are:
- Test Gel: Piroxicam plus Counterirritant (brand name Counterpain® PXM). This gel combines an anti-inflammatory drug (Piroxicam) with ingredients that create a distinct warming or cooling sensation on the skin (methyl salicylate, eugenol, and menthol).
- Comparator Gel A: Piroxicam gel only (brand name Pirofel®). This gel contains the anti-inflammatory drug Piroxicam by itself.
- Comparator Gel B: Diclofenac gel (brand name Hotin® DCL). This is another very common and well-studied anti-inflammatory gel, often considered a standard treatment for this type of pain.
The study's central hypothesis is that the Piroxicam-plus-counterirritant gel is not inferior to the other two and provides a similar level of pain relief and safety. This type of study is called an equivalence trial.
How is the Study Designed?
This is a Phase 3, Randomized, Controlled, Multi-center, Single-blind, Parallel-group study. Here's what each of these terms means:
- Phase 3: This is a confirmatory stage of research, often done after a product is already on the market, to confirm its effectiveness and safety in a larger group of people compared to standard treatments.
- Randomized: Participants will be assigned to one of the three gel groups purely by chance, using a computer-generated list (like flipping a coin). This randomization is the best way to ensure the three groups are comparable at the start of the study, minimizing bias in the final results.
- Controlled: The test gel (Piroxicam plus Counterirritant) is being compared against two "control" groups who are using other known and accepted treatments (Piroxicam-only and Diclofenac gels).
- Multi-center: The study will take place at two different clinic locations: Klinik Utama Eminence and St. Carolus Sports Clinic by Eminence. This helps in recruiting enough participants and makes the results more generalizable to the wider population.
- Single-blind: In this type of study, the participants do not know which gel they are using. To achieve this, all the original gel tubes will be completely covered with a plain white sticker, hiding their brand identity. They will only have a study label with a unique code. This prevents the participants' expectations (e.g., thinking a particular brand works better) from influencing how they report their pain. The doctors and physiotherapists who assess the participants will also not know which gel corresponds to which code, ensuring their evaluations are objective. Only the study coordinator and the principal investigator will have access to the master list that links the codes to the actual gels.
- Parallel-group: This means that each participant will only use one type of gel for the entire duration of the study. They will not switch to another gel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
PXM + Counterirritant
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.
干预措施: Piroxicam plus Counterirritant (brand name Counterpain® PXM). (Drug)
Comparator Drugs
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.
干预措施: Diclofenac Sodium 10 mg (Brand Name Hotin® DCL) (Drug)
Comparator Drugs
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.
干预措施: Piroxicam 0.5% (Brand name Pirofel® gel) (Drug)
结局指标
主要结局
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.
时间窗: From enrollment to the end of treatment at 4 months
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
次要结局
未报告次要终点
研究者
Erica Kholinne
Principal Investigator
Taisho Pharmaceutical Indonesia