A Double-blind, Randomized, Multicentric, Comparative, Phase-IV Clinical Trial to Evaluate Safety, Efficacy and Tolerability of oral Tablets of FDC of Aceclofenac 100 mg, Paracetamol 325 mg and Serratiopeptidase 15 mg of Synokem Pharmaceuticals Limited in comparison with Aceclofenac 100mg and Paracetamol 325 mg in the treatment of Acute Painful Musculospastic Conditions.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 6
- 主要终点
- Clinical global impression- Improvement (CGI-I) on a 7-point scale, pain intensity on a 11-point numerical rating scale (PI-NRS) will be measured from baseline to end of the study.
研究概览
简要总结
All eligible patients clinically manifesting with symptoms of acute painful musculospastic conditions would be informed about the nature of the study and consent would be taken. After informed consent is obtained, patients will be screened with respect to laboratory tests and inclusion/exclusion criteria will be randomized on Day 1. Patients that are determined eligible based upon the screening and inclusion criteria will enter the 7 days treatment period. Approximately 250 patients will be randomized in the study. Patients will be randomized at each center to receive one of the two strengths of either the study drug (Aceclofenac 100 mg, Paracetamol 325 mg and Serratiopeptidase 15 mg Tablets) or the comparator drug starting from the day of randomization to Day 7. Patients will be given tablets of either the study drug or the comparator as per their random allocation, for a period of 4 days during the first visit and for another 3 days after first follow up on Day 4. Patients will be provided with drug sufficient for 7-day treatment duration in a strip packs. Patients will be called on as per the flow chart of the trial after receiving active drug treatment for follow-up. At the time of follow-up, they will be judged on the basis of interrogation and clinical global impression- Improvement (CGI-I) on a 7-point scale, pain intensity on a 11-point numerical rating scale (PI-NRS) and Treatment compliance will be judged by the return of empty strips and crosschecked with diary. Clinical Global Impression of Improvement (CGI-I) will be administered at the completion visit. Throughout the trial period, the patients will be in continuous communication for recording the adverse event/serious adverse event or adverse reactions. Laboratory investigations should be conducted at first and last visit. In every visit patient will be evaluated for general, systemic and physical examination, vital signs, concomitant medication and AE / SAE Recording. The total duration of the study will be at least 7 days for Acute Painful Musculospastic Conditions.
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
- •Male or female patients of 18 years and 60 years (both Inclusive),
- •Willing to provide written informed consent.
- •Subjects suffering from acute painful conditions with spasm 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.
- •Patients willing to comply with the protocol requirements.
排除标准
- •Patients known, or to be 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 judgement 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 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.
- •Patients with chronic and degenerative conditions of pain.
- •Patients with the history of significant cardiovascular disorders, central nervous system disorders, endocrine disorder and other severe condition like asthma, uncontrolled hypertension and collagen disorders that may affect patient safety or difficult to evaluate the efficacy of the product.
- •Patients who have participated in any clinical trial in the past one month.
结局指标
主要结局
Clinical global impression- Improvement (CGI-I) on a 7-point scale, pain intensity on a 11-point numerical rating scale (PI-NRS) will be measured from baseline to end of the study.
时间窗: Screening Visit (Visit 1), | Visit 2 / Day 1, | Visit 3 / Day 4 and | End of Study (Visit 4 / Day 7).
次要结局
- Adverse events reported during the study.(Throughout the study.)
- Changes in the inflammatory markers (C-reactive protein) from baseline to end of the study.(Screening Visit (Visit 1),)
- Serious adverse events reported during the study.(Throughout the study.)
- Changes in clinical laboratory parameters from baseline to end of the study visit.(Screening Visit (Visit 1) and)
研究者
Dr Aditya Kaushik
Synokem Pharmaceuticals Ltd.