CTRI/2025/06/088790尚未招募3 期
A Randomized, Open Label, Parallel Group, Clinical Study to evaluate the efficacy, safety and tolerability of fixed-dose combination of Aceclofenac 100 mg plus Paracetamol 500 mg tablets of Ajanta Pharma Ltd. vs Beofenac 100 (Aceclofenac Film-Coated Tablets 100 mg) of Almirall, Spain and Panadol Advance 500 (Paracetamol Tablets 500 mg) of Glaxo Smith Kline S.A in the treatment of Acute Painful Musculoskeletal/Musculospastic Conditions.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Reduction of pain as measured by Numerical Rating Scale (NRS) from Baseline to end of study that is 7th day of treatment.
研究概览
简要总结
| Following a screening visit, Subjects who meet all of the inclusion criteria and none of the exclusion criteria will be randomized to receive either fixed-dose combination of Aceclofenac 100 mg plus Paracetamol 500 mg tablets of Ajanta Pharma Ltd. or Beofenac 100 (Aceclofenac Film-Coated Tablets 100 mg) of Almirall, Spain and Panadol Advance 500 (Paracetamol Tablets 500 mg) of Glaxo Smith Kline S.A . Subjects will be provided with subject’s diary card at randomization visit, which needs to be brought during each subsequent visit till the last visit. Follow up visit will be on Day 3 and Final Visit on Day 7 of treatment to assess efficacy, safety and tolerability. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
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 and female subjects 18 to 65 years of age (Both Inclusive).
- •Subjects with acute painful musculoskeletal/musculospastic conditions like pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, minor pain of arthritis, muscular aches and backache.
- •Subjects who have pain score of at least 4 on a Numerical Rating Scale (11- point scale).
- •Subjects who are willing to give informed consent for participation in the study and willing to adhere to all protocol procedures.
排除标准
- •Subject has known allergy to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or other contraindication to any compound present in the study medication.
- •Subjects who have used NSAIDS or any other analgesic in last 24 hours.
- •Subjects who have taken any corticosteroid, indomethacin, glucosamine + chondroitin, within 3 months prior to the screening or intra-articular treatment injections with corticosteroid or hyaluronic acid within 6 months preceding the treatment period.
- •Subjects with clinically significant uncontrolled cardiovascular disease.
- •Subjects with history of peptic ulceration or active gastrointestinal (GI) bleeding or inflammatory bowel diseases.
- •Subjects with a history/existing case of bronchial asthma.
- •Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases or malignancies.
- •Subjects with abnormal Liver Function Test (LFT) values more than 3 times the upper limit of normal.
- •Subjects with renal dysfunction with serum creatinine value ≥ 1.5 mg/dl at screening.
- •Subjects with known alcohol or other substance abuse within last one year as per DSM-5 criteria.
- •Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit.
- •Pregnant and lactating women or the women of child bearing age who are not ready to use effective means of contraception.
结局指标
主要结局
Reduction of pain as measured by Numerical Rating Scale (NRS) from Baseline to end of study that is 7th day of treatment.
时间窗: Reduction of pain as measured by Numerical Rating Scale (NRS) from Baseline to end of study that is 7th day of treatment.
次要结局
- Change from Baseline in the Subjects Global Assessment.(Change from Baseline in the Physician’s Global Assessment.)
研究者
Dr. K. Sanjeev Kumar
Government Medical College & Government General Hospital
研究点 (1)
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