A Prospective Randomized Double blind Comparative Multicenter Phase IV Clinical Trial to evaluate the efficacy and safety of Aceclo MR Tablet Fixed dose combination tablet of Aceclofenac 100mg plus Paracetamol 325 mg plus Chlorzoxazone 500 mg in comparison with Aceclofenac 100mg plus Paracetamol 325 mg in the treatment of acute musculoskeletal pain associated with spasm.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 260
- 试验地点
- 6
- 主要终点
- To compare the efficacy of ACECLO MR Tablet Fixed-dose combination tablet of Aceclofenac 100mg plus Paracetamol 325mg plus Chlorzoxazone 500mg versus ACECLO PLUS Tablet Fixed dose combination tablet of Aceclofenac 100mg plus Paracetamol 325mg in the treatment of acute musculoskeletal pain associated with spasm.
研究概览
简要总结
“A Prospective, Randomized, Double blind, Comparative, Multicentre, Phase IV Clinical Trial to evaluate the efficacy and safety of Aceclo MR Tablet (Fixed dose combination tablet of Aceclofenac 100mg + Paracetamol 325 mg + Chlorzoxazone 500 mg) in comparison with Aceclofenac 100mg + Paracetamol 325 mg in the treatment of acute musculoskeletal pain associated with spasm.â€
Test product: Aceclo MR Tablet (Fixed-dose combination tablet of Aceclofenac 100mg + Paracetamol 325 mg + Chlorzoxazone 500 mg)
Manufactured by: Aristo Pharmaceuticals Private Limited**.**
Reference Product: ACECLO PLUS® Tablet (Fixed dose combination tablet of Aceclofenac 100mg + Paracetamol 325 mg).
Primary Objective of the Study
To compare the efficacy of Aceclo MR Tablet (Fixed-dose combination tablet of Aceclofenac 100mg + Paracetamol 325 mg + Chlorzoxazone 500 mg) versus ACECLO PLUS® Tablet (Fixed dose combination tablet of Aceclofenac 100 mg + Paracetamol 325 mg) in the treatment of acute musculoskeletal pain associated with spasm.
Secondary Objective:
To compare the safety of Aceclo MR Tablet (Fixed-dose combination tablet of Aceclofenac 100mg + Paracetamol 325 mg + Chlorzoxazone 500 mg) versus ACECLO PLUS® Tablet (Fixed dose combination tablet of Aceclofenac 100 mg + Paracetamol 325 mg) in the treatment of acute musculoskeletal pain associated with spasm.
Treatment Duration7 days ± 2 days.
Study Endpoints
Efficacy:
- Mean change in pain intensity (100 mm in VAS) from baseline to day 7.
- Assessment of Muscle spasm scale (3-point scale assessing the severity of spasms ranging from ‘1=mild’ ‘2=moderate’ ‘3=severe’).
Global assessment of Efficacy by Investigator and Patient
Safety :
· Any adverse event reported voluntarily, observed or enquired during the study period.
· Any clinically significant change in the value of laboratory tests, vital signs and physical examination findings during the study compared to baseline.
Global assessment of Safety by Investigator and Patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
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 of either gender between 18 and 60 years of age (inclusive of both).
- •Patients of acute musculoskeletal pain with spasm having VAS score ≥ 40 (on 100 mm VAS scale)
- •Patients who are willing to provide written informed consent.
排除标准
- •Patients with known hypersensitivity to study drugs.
- •History of auto-immune disease.
- •Concurrent use of corticosteroids.
- •Any medication or indication that might point to an increased risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel make the subject inappropriate for inclusion.
- •Participation in other clinical trials the last three months and during study participation.
- •Patients with history of epilepsy, or those at risk of seizures or taking seizure drugs.
- •In pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
- •Patients with galactose or fructose intolerance.
- •Patients with severe renal impairment, including those receiving dialysis.
- •Patients with pre-existing gallbladder disease.
- •Active peptic ulcer disease or history of peptic ulcer, bleeding disorder and fecal blood loss.
- •Patients taking muscle relaxants, NSAIDs (anti-inflammatory drugs) and pain relievers within last 14 days.
- •Patients with significant cardiac, hepatic dysfunction, and hematologic disorder.
结局指标
主要结局
To compare the efficacy of ACECLO MR Tablet Fixed-dose combination tablet of Aceclofenac 100mg plus Paracetamol 325mg plus Chlorzoxazone 500mg versus ACECLO PLUS Tablet Fixed dose combination tablet of Aceclofenac 100mg plus Paracetamol 325mg in the treatment of acute musculoskeletal pain associated with spasm.
时间窗: Visit 1 Day 0 Screening and enrollment. | Visit 2 Day 4 Follow up visit. | Visit 3 Day 7 End of study.
次要结局
- To compare the safety of ACECLO MR Tablet (Fixed-dose combination tablet of Aceclofenac 100mg + Paracetamol 325mg + Chlorzoxazone 500mg) versus ACECLO PLUS® Tablet (Fixed dose combination tablet of Aceclofenac 100mg +Paracetamol 325mg) in the treatment of acute musculoskeletal pain associated with spasm.
研究者
Dr Manish Maladkar
Aristo Pharmaceuticals Private Limited