CTRI/2021/01/030508进行中（未招募）4 期
A phase IV, randomized, multicentre, prospective, open-label, comparative, post-marketing study to evaluate safety & efficacy of combination of Diclofenac, Paracetamol, Trypsin and Chymotrypsin versus combination of Diclofenac and Paracetamol in patients with soft tissue injury.
Cachet Pharmaceutical Pvt Ltd12 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2021年1月15日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
- 试验地点
- 12
- 主要终点
- The primary objective of this study is to evaluate the efficacy of combination of Diclofenac,
研究概览
简要总结
A phase IV, randomized, multicentre, prospective, open-label, comparative, post-marketing study to evaluate safety & efficacy of combination of Diclofenac, Paracetamol, Trypsin and Chymotrypsin versus combination of Diclofenac and Paracetamol in patients with soft tissue injury.
Study Objective(s):
Primary Objective:
- The primary objective of this study is to evaluate the efficacy of combination of Diclofenac, Paracetamol, Trypsin and Chymotrypsin versus combination of Diclofenac and Paracetamol in terms of reduction in swelling score from baseline to End of treatment.
Secondary objectives:
-
To evaluate change in VAS score from baseline to EOT
-
To evaluate rate of pain relief during the study. (VAS score)
3. Use of rescue medication
- To evaluate the safety and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients between 18-65 years of age.
- •Patients with soft tissues injuries associated with inflammation & swelling like sprains, strains, hematomas (Sub-dermal type only), contusion, acute sports injuries (excluding suspected fractures), seen within 24 hours of the injury at screening.
- •Patients with pain VAS score between
- •Patients with ankle injury not requiring interventional treatment
- •Patients willing to give written informed consent and willing to comply with trial protocol.
排除标准
- •Patients previously hypersensitive to diclofenac, paracetamol, trypsin or chymotrypsin
- •Patients with significant gastrointestinal complications, such as but not limited to the following conditions: a.
- •Gastrointestinal ulcer b.
- •Gastrointestinal bleeding c.
- •Crohn’s disease or ulcerative colitis.
- •Any long standing/chronic inflammatory condition like rheumatoid arthritis, osteoarthritis or spondylitis where the patient had been on long term anti-inflammatory drugs including nonsteroidal anti-inflammatory drugs, corticosteroids or analgesics.
- •Patients with wounds, tissue abscesses and cellulitis.
- •Patients with injuries (such as sprains/strains) requiring immobilization for more than 48 hours, orthopaedic or surgical intervention.
- •Patients known to have established congestive heart failure, cerebrovascular disease, renal and liver disease or any clinically significant disease as per investigator discretion.
- •Patients who are known seropositive cases of HIV, Hepatitis B or Hepatitis C.
- •Patients with localized skin disease (e.g. eczema, psoriasis etc.) at the site of injury that may interfere in evaluation of the injury.
- •Patients who had participated in any clinical trial within one month prior to enrolment.
- •Patients who have taken prohibited medications (other NSAIDs, opioid analgesics and systemic corticosteroids) in last 7 days.
- •Pregnant and lactating women or the women of child bearing age who are not practicing effective method of contraception.
结局指标
主要结局
The primary objective of this study is to evaluate the efficacy of combination of Diclofenac,
时间窗: Patients completing treatment from baseline to EOT i.e. day 6 to day 8
Paracetamol, Trypsin and Chymotrypsin versus combination of Diclofenac and Paracetamol
时间窗: Patients completing treatment from baseline to EOT i.e. day 6 to day 8
in terms of percentage reduction in swelling from baseline to End of treatment.
时间窗: Patients completing treatment from baseline to EOT i.e. day 6 to day 8
次要结局
- 1. To evaluate change in VAS score from baseline to EOT(2. To evaluate rate of pain relief during the study.(reduction in VAS score from baseline))
研究者
研究点 (12)
Loading locations...
相似试验
已完成
4 期
Epoprostenol for Injection in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionNCT01105091Actelion30
已完成
4 期
Study of Voncento® in Subjects With Von Willebrand DiseaseVon Willebrand DiseaseNCT02552576CSL Behring26
已完成
不适用
Safety and Effectiveness of Cinnomer® (Glatiramer Acetate) in Multiple Sclerosis (MS) Treatment in IranRelapsing Multiple SclerosisNCT04928313Cinnagen368
已完成
4 期
Clinical Outcomes of Tiotropium Plus Fluticasone Propionate/Salmeterol Compared With Tiotropium for Chronic Obstructive Pulmonary Disease (COPD) in KoreaChronic Obstructive Pulmonary DiseaseNCT00864812The Korean Academy of Tuberculosis and Respiratory Diseases509
已完成
4 期
Post marketing study to assess side effects, antibody development and effectiveness of Hetero-RituximabCTRI/2018/03/012588Hetero Drugs Limited200