A Double blind Randomized Multicentric Comparative Phase IV Clinical Trial to Evaluate the Safety Tolerability and Efficacy of oral Tablets of ACECLO SERA Fixed dose combination of Aceclofenac 100 mg plus Paracetamol 325 mg plus Serratiopeptidase 15 mg in comparison with Aceclofenac 100 mg plus Paracetamol 325 mg in the treatment of acute painful musculospastic conditions.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 5
- 主要终点
- To compare the efficacy of ACECLO-SERA (Fixed dose combination tablet of Aceclofenac 100 mg plus Paracetamol 325 mg plus Serratiopeptidase 15 mg tablet versus ACECLO PLUS Fixed dose combination tablet of Aceclofenac 100 mg plus Paracetamol 325 mg in the treatment of acute painful musculospastic conditions.
研究概览
简要总结
**Study Title:**A Double blind Randomized Multicentric Comparative Phase IV Clinical Trial to Evaluate the Safety Tolerability and Efficacy of oral Tablets of ACECLO SERA Fixed dose combination of Aceclofenac 100 mg plus Paracetamol 325 mg plus Serratiopeptidase 15 mg in comparison with Aceclofenac 100 mg plus Paracetamol 325 mg in the treatment of acute painful musculospastic conditions.
Test Product: Aceclo SERA Fixed-dose combination tablet of Aceclofenac 100 mg plus Paracetamol 325 mg plus Serratiopeptidase 15 mg.
Reference Product: Aceclo Plus Fixed dose combination tablet of Paracetamol 325mg plus Aceclofenac 100 mg.
Primary Objective:
To compare the efficacy of ACECLO SERA (Fixed dose combination tablet of Aceclofenac 100 mg plus Paracetamol 325 mg plus Serratiopeptidase 15 mg tablet versus ACECLO PLUS Fixed dose combination tablet of Aceclofenac 100 mg plus Paracetamol 325 mg in the treatment of acute painful musculospastic conditions.
Secondary Objective:
To compare the safety & tolerability of ACECLO SERA (Fixed dose combination tablet of Aceclofenac 100mg plus Paracetamol 325mg plus Serratiopeptidase 15mg tablet versus ACECLO PLUS Fixed dose combination tablet of Paracetamol 325 mg plus Aceclofenac 100 mg in the treatment of acute painful musculospastic conditions.
Treatment Duration
7 days
Study Endpoints
Efficacy:
- Mean change in pain intensity numerical rating scale (PI NRS) from baseline to day
- Clinical Global Impression of improvement (CGI-I) a 7 point scale will be used for assessment of improvement in pain.
Safety and Tolerability:
- 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 & tolerability 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 suffering from acute pain with spasm such as prolapsed intervertebral disc, sprains and dislocations, spondylosis ( Lumbar, cervical, ankylosing spondylosis), spinal stenosis, periarthritis, frozen shoulder, prepatellar bursitis, spondylolisthesis, low back pain, tendonitis, tenosynovitis, bursitis.
- •Patients 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 active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
- •Patients with pre-existing gallbladder disease.
- •Active peptic ulcer disease.
结局指标
主要结局
To compare the efficacy of ACECLO-SERA (Fixed dose combination tablet of Aceclofenac 100 mg plus Paracetamol 325 mg plus Serratiopeptidase 15 mg tablet versus ACECLO PLUS Fixed dose combination tablet of Aceclofenac 100 mg plus Paracetamol 325 mg in the treatment of acute painful musculospastic conditions.
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 & tolerability of ACECLO-SERA (Fixed dose combination tablet of Aceclofenac 100mg plus Paracetamol 325mg plus Serratiopeptidase 15mg tablet versus ACECLO PLUS Fixed dose combination tablet of Paracetamol 325 mg plus Aceclofenac 100 mg in the treatment of acute painful musculospastic conditions.(Visit 1 Day 0 Screening and enrollment.)
研究者
Dr Manish Maladkar
Aristo Pharmaceuticals Private Limited