Evaluation of Safety and Efficacy of Etodolac Injection in Patients with Post-Operative Orthopedic Pain.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 26
- 主要终点
- To assess the safety and tolerability of intramuscular injection of Etodolac based on the incidence of adverse events (clinical and laboratory) in the treatment of post operative orthopedic pain.
研究概览
简要总结
We had conducted phase III clinical trials with 158 patient initially and later with additionally 107 patients for treatment of post operative orthopedic pain . The combined result demonstrated that the patients treated with Etodolac injection had significantly less pain intensity scores assessed on VAS and VRS and significantly better efficacy in terms of pain relief score in comparison with those treated with diclofenac injection. Based on the result of phase III study DCGI suggested to conduct phase IV clinical study. Thus, the phase IV study is planned in at least 500 patients. The primary objective of conducting phase IV study is to assess the safety and tolerability of intramuscular injection of Etodolac based on incidence of adverse events (clinical and laboratory) in the treatment of post operative orthopedic pain.
The secondary objectives of phase IV study is to assess the efficacy of Etodolac injection by evaluating the changes in the pain intensity score using VAS and VRS and pain relief score assessed on Likert scale at 24 hour after 1st dose of study drug administration, to evaluate the number of patients who required rescue medication and enumerate the total doses of rescue medication administered, to evaluate patient’s and investigator’s global efficacy assessment using five points Likert scale after 24 hours from 1st dose of study drug administration .
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 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 and female patients aged between 18 and 65 years.
- •Patients undergoing open reduction and internal fixation of long bone fracture surgery.
- •Patients with the post operative orthopedic pain of at least 5 cm on the 10 cm pain intensity VAS and at least a score if 2 on 4 point VRS 4) Patients fulfilling the American Society of Anesthesiology (ASA) physical status classification of Class I and Class II 5) Patients able to understand and willing to fully comply with study procedures and restrictions 6) Patients ready to give informed consent, as per applicable regulatory requirements, for participation in the study.
排除标准
- •Patients who are unable to remain at the hospital for the duration of the study.
- •Patients having complication during or after surgical procedure.
- •Patients with systemic infection before the surgery is performed 4) Patients with abnormal renal function (Serum Cr>1.5 mg/dL) 5) Patients with abnormal liver function (AST and ALT, total bilirubin or alkaline phosphatase more than 2.5 times the upper limit of normal values) 6) Patients with known history of HIV 1 or HIV 2, Hepatitis B or C viruses or syphilis infection or malignancy 7) Patients with dementia, other cognitive impairment prohibiting informed consent.
- •Patients with any other clinically significant abnormality(ies) interfering with assessment of disease under evaluation.
结局指标
主要结局
To assess the safety and tolerability of intramuscular injection of Etodolac based on the incidence of adverse events (clinical and laboratory) in the treatment of post operative orthopedic pain.
时间窗: Within 24 hrs from 1st dose of study drug administration.
次要结局
- 1. To assess the efficacy of Etodolac injection by evaluating changes in pain intensity score using verbal rating scale, visual analogue scale, pain relief score assessed on Likert scale.(2.To evaluate the number of patients who required rescue medication and enumerate the total doses of rescue medication administered.)