A prospective, single arm, post-marketing, investigator-initiated study to evaluate safety, tolerability and efficacy of fixed dose combination (FDC) of Nimesulide and Paracetamol in patients with chronic painful conditions
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in liver function (AST, ALT, Serum Bilirubin) tests, Change in renal function, change in heart burn score
研究概览
简要总结
In this study, patients with chronic painful conditions (osteoarthritis knee, OA hip, frozen shoulder, bursitis, chronic ligament injury / sprain) will be prescribed with FDC of nimesulide-paracetamol according to the investigator’s discretion as per routine clinical practice. The patients will be followed up on an outpatient basis on Day 7 (Visit 2), Day 14 (Visit 3), Day 21 (Visit 4), and Day 28 (Visit 5). Visit 4 or Visit 5 may be considered the end of-study visit, depending on the duration of treatment required by the patient. Primary endpoints of the study are change in liver, renal and Heart burn score from baseline to week 1,2,3 and 4. For the effectiveness reduction of pain measured by NRS scale at the end of week 1,2,3 and 4.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender more than 18 years of age
- •Patients with chronic painful conditions such as osteoarthritis knee, OA hip, frozen shoulder, bursitis, chronic ligament injury / sprain requiring treatment with FDC of nimesulide-paracetamol for 3 to 4 weeks time as per routine clinical practice
- •Patients willing to provide written informed consent.
排除标准
- •Patients with past history of hypersensitivity to study drugs
- •Patients who have used NSAIDS or any other analgesic in last 24 hours
- •Patients with history of GI bleeding
- •Patients with clinically significant uncontrolled cardiovascular disease
- •Patients with hepatic dysfunction (serum transaminases more 3 x Upper Normal Limit) or renal dysfunction (serum creatinine more 2.5 mg/dl) at screening
- •Pregnant and lactating mothers and women of child bearing potential who are not taking adequate contraceptive measures
- •Patients prescribed / require any other medication known to interact with the study medication.
- •Any other reason for which the investigator feels that the patient should not participate.
结局指标
主要结局
Change in liver function (AST, ALT, Serum Bilirubin) tests, Change in renal function, change in heart burn score
时间窗: from baseline to Week 1 / 2 / 3 and 4.
次要结局
- Reduction of pain as measured by the numerical rating scale (NRS)(at the end of week 1, week 2, week 3 and week 4)
研究者
Dr Jayesh Sanmukhani
Clinexcel Research