CTRI/2025/04/085094已完成4 期
A Randomized, Multicenter, Comparative, Open label, Phase-IV study to evaluate safety and efficacy of the 3-Drug-Fixed Dose Combination Tablet of Paracetamol 325 mg, Chlorzoxazone 250 mg and Aceclofenac 100 mg in comparison with Paracetamol 325 mg and Aceclofenac 100 mg Tablet administered BID in adult patients with Acute Musculoskeletal Pain Associated with Spasm.
Unison Pharmaceuticals Pvt. Ltd.4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年4月28日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- 1.Percentage of patients who shows any incidence of drug associated adverse effect.
研究概览
简要总结
A Randomized, Multicenter, Comparative, Open label, Phase-IV study to evaluate safety and efficacy of the 3-Drug-Fixed Dose Combination Tablet of Paracetamol 325 mg, Chlorzoxazone 250 mg and Aceclofenac 100 mg in comparison with Paracetamol 325 mg and Aceclofenac 100 mg Tablet administered BID in adult patients with Acute Musculoskeletal Pain associated with spasm. 200 subjects (adult male/female patients of age between 18-65 years) having moderate to severe pain, who are diagnosed by rating the pain between grade 7 to 10 on numeric pain scale by principal investigator, would be screened for enrolment, as per Inclusion/Exclusion criteria. Assessment of efficacy will be done by Numeric Pain Scale by making three pain ratings, corresponding to current, best and worst pain experienced over the past 24 hours. The average of the 3 ratings will be used to represent the patient’s level of pain over the previous 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who have given their written consent to participate voluntarily and understand to adhere to protocol for completion of study.
- •Age 18.00 Years to 65.00 Years (inclusive both).
- •Patient is able to take oral medication and willing to adhere to schedule of treatment.
- •04.Patient’s willingness to comply with all study procedures and availability for the duration of the study.
- •If male, must agree to use a reliable contraception method (i.e., abstinence, condom or partner using an IUD)
- •If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e., abstinence, intrauterine device [IUD], or partner agreeing to use male-condom).
- •07.Patients diagnosed (by the treating physician/PI) to have acute pain of musculoskeletal nature and as self-rated by the patient 7 to 10 on Numerical pain scale
- •Patients must agree to not consume Alcohol, any other substance of abuse during their participation in the trial.
排除标准
- •1.Active participation in any other clinical trial. 2.Known allergy to the study drugs used in the trial. (Chlorzoxazone,Paracetamol, Aceclofenac). 3.Patients with any other clinically significant uncontrolled systemic diseases such as gastrointestinal, respiratory, cardiovascular, renal,neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy, as judged by the investigator. 4.History of auto-immune disease. 5.Patients with the history of epilepsy, or those at risk of seizures, or taking seizure drugs. 6.Pregnant females, lactating women or women of childbearing age who are not using an acceptable method of birth control. 7.Patients with galactose or fructose intolerance.
- •Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities. 9.Patients with pre-existing gallbladder disease. 10.Active peptic ulcer disease.
- •Patients taking any other medicines that might interact with one of the study medications.
- •Patient with known G6PD deficiency 13.Alcohol dependence, chronic malnutrition or dehydration, severe hypovolaemia (IV) or any other condition which may interfere with the study, as judged by the Investigator. 14.Patients with concomitant use of other NSAIDs,antiplatelets, anticoagulants or any other aid for pain. 15.Patients needing any treatment (associated with muscle spasm) other than the study drugs.
- •as diagnosed by the Investigator.
- •Any history/ symptoms/ suspicion of patients having hepatic or renal impairment, as judged by the Principal Investigator. 17.If patient is on any other treatment or additional treatment aid for pain (oral, dermal, drug-plaster, heat-pad or any similar contact therapy, herbal, homeopathic or any other nature) during the study duration.
- •Patients who have any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the investigator, could affect the patient participation in the study.
结局指标
主要结局
1.Percentage of patients who shows any incidence of drug associated adverse effect.
时间窗: 8 Days
2.Percentage of patients where the PI needs to stop the treatment before day 8 due to drug associated toxicity.
时间窗: 8 Days
次要结局
- 1.Percentage reduction in pain at day 8.(2.Percentage of the patients where the PI stops the treatment before the day 8, as the pain has subsided & the need for pain management does not exist anymore.)
研究者
Dr Sunil Maheshwari
Prime Care Hospital
研究点 (4)
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