A multicentric, open labelled, non-comparative, single dose observational study to assess the local tolerability of Diclofenac AQ Injection(DiclofenacSodium 75 mg/ml injection manufactured by Akums Drugs andPharmaceuticals Ltd., India.) upon Intramuscular administration in patients having severe inflammatory orspasmodic pain
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- To assess the local tolerability of Diclofenac AQ Injection (Diclofenac Sodium 75 mg/ml injection manufactured by Akums Drugs and Pharmaceuticals Ltd., India) upon intramuscular administration in patients having severe inflammatory or spasmodic pain
研究概览
简要总结
The aim of thisstudy is to assess the local tolerability of Diclofenac AQ Injection(DiclofenacSodium 75 mg/ mL injection manufactured by Akums Drugs and PharmaceuticalsLtd., India) upon IM administration in patients having severe inflammatory orspasmodic pain in a multicentric, open labelled, non-comparative, single doseobservational clinical trial
Skeletal musclespasm results from inflammation that occurs when a muscle is overstretched ortorn. It begins as a muscle strain, which doesn’t sound like a serious injury,but it can cause severe low back pain. Many people go to the emergency roomeach year because of a muscle strain. In fact, most episodes of acute lowerback pain are caused by damage to the muscles and/or ligaments in the low back.
Muscle strainsare also known as a pulled muscle. When the muscles in the lower back arestrained or torn, the area around the muscles can become inflamed. Withinflammation, the muscle can spasm leading to severe low back pain anddifficulty moving.
Muscle spasmsrange in intensity from mild twitches to severe pain. The spastic muscle mayfeel harder than normal to touch, and/or appear visibly distorted. Causes ofskeletal muscle spasm are lifting of heavy object, lifting while twisting, or asudden movement or fall
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having severe inflammatory or spasmodic pain with VAS score up to 7 (mild to moderate pain) and requiring immediate relief.
- •Patients who are able to and willing to provide written informed consent.
排除标准
- •Hypersensitivity to the drug components or other drug from same class
- •Patient unable to refrain from alcohol, psychoactive drugs, and sedatives including sleeping preparations (eg benzodiazepines) for the duration of their participation in the study
- •Patient with history of drug of abuse
- •Patients recently diagnosed any viral or bacterial infection.
结局指标
主要结局
To assess the local tolerability of Diclofenac AQ Injection (Diclofenac Sodium 75 mg/ml injection manufactured by Akums Drugs and Pharmaceuticals Ltd., India) upon intramuscular administration in patients having severe inflammatory or spasmodic pain
时间窗: 24 hours post injection
次要结局
- To monitor the adverse events.(Global assessment by patient at the end of study)