A Randomized, Multicenter, Comparative, Open label, Phase-IV study to evaluate the safety & efficacy of the 3-Drug-Fixed Dose Combination (FDC) tablet of Paracetamol 325 mg, Chlorzoxazone 250 mg, and Diclofenac Sodium 50 mg in comparison with 2-Drug-FDC tablet of Paracetamol 325 mg and Diclofenac Sodium 50 mg administered TID in adult patients with acute musculoskeletal pain associated with spasm.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Percentage of patients who shows any incidence of drug associated adverse effect during 8 days of treatment
研究概览
简要总结
A Randomized, Multicenter, Comparative, Open label, Phase-IV study to evaluate the safety & efficacy of the 3-Drug-Fixed Dose Combination (FDC) tablet of Paracetamol 325 mg, Chlorzoxazone 250 mg, and Diclofenac Sodium 50 mg in comparison with 2-Drug-FDC tablet of Paracetamol 325 mg and Diclofenac Sodium 50 mg administered TID in adult patients with acute musculoskeletal pain associated with spasm.
200 subjects (adult male/female patients of age Between 18 -60) 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.
Age: 18 Years to 60 Years (inclusive of both).
Assessment by Percentage of patients who shows any incidence of drug associated adverse effect will be evaluated as a primary end-point and efficacy in terms of % pain reduction will be the secondary objective of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who have given their written consent to participate voluntarily and agrees to adhere to the protocol for completion of study.
- •02.Male and Female between the age of 18 to
- •03.Patient is able to take oral medication and is willing to comply with the treatment schedule as well as all study procedures.
- •04.Patient’s willingness to comply with all study procedures and availability for the duration of the study.
- •05.Female participants must be non-lactating, not pregnant, and utilizing a reliable method of contraception, such as abstinence, an intrauterine device (IUD), or a male partner who agrees to use condoms.
- •06.Male participants must agree to use a reliable method of contraception, such as abstinence, condoms, or having a partner who utilizes an intrauterine device (IUD).
- •07.Patients diagnosed (by the treating physician/PI) to have Acute Painful musculospastic condition such as prolapsed intervertebral disc, sprains and dislocations, spondylosis (lumbar, cervical, ankylosing spondylosis), spinal stenosis, periarthritis, frozen shoulder, prepatellar bursitis, spondylolisthesis, low-backpain, tendonitis, tenosynovitis, bursitis, and as self-rated 7-10 on the Numerical pain scale.08.Patients must agree to abstain from consuming Alcohol, any other substance of abuse during their participation in the trial.
排除标准
- •Active participation in any other clinical trial.
- •Known allergy to the study drugs used in the trial. (Diclofenac, Paracetamol, Chlorzoxazone).
- •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. 04.Patients taking any other medicine that might interact with one of the study medications. 05.History of auto-immune disease. 06.Active peptic ulcer disease.
- •Pregnant females, lactating women or women of childbearing age who are not using an acceptable method of birth control.
- •Patients with a history of epilepsy, or those at-risk seizures or taking antiepileptic drugs.
- •Patient with known G6PD deficiency. 10.Patients with pre-existing gallbladder disease.
- •Patients with galactose or fructose intolerance
- •Patients with active liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormalities.
- •Alcohol dependence or any other condition that may affect the study, as assessed by the Investigator.
- •Patients with concomitant use of other NSAIDs, antiplatelets, anticoagulants or any other aid for pain.
- •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.
- •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 with any severe and/or uncontrolled medical conditions or other conditions that, in the investigator’s opinion may affect the patient’s participation in the study.
结局指标
主要结局
Percentage of patients who shows any incidence of drug associated adverse effect during 8 days of treatment
时间窗: Percentage of patients who shows any incidence of drug associated adverse effect during 8 days of treatment | Percentage of patients where the PI needs to stop the treatment before day 8 due to drug-associated toxicity
Percentage of patients where the PI needs to stop the treatment before day 8 due to drug-associated toxicity
时间窗: Percentage of patients who shows any incidence of drug associated adverse effect during 8 days of treatment | Percentage of patients where the PI needs to stop the treatment before day 8 due to drug-associated toxicity
次要结局
- Percentage reduction in pain at day 8(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.)