A Randomized, Two Arm, Open Label, Active Controlled, Multicentric Clinical Study to Evaluate the Efficacy and Safety of a Topical Solution of Diclofenac (2.32% w/v) in comparison with Diclofenac Topical Gel (1.16% w/w) in Acute Painful Musculoskeletal Conditions.
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 250
- 试验地点
- 7
- 主要终点
- Improvement in pain intensity from baseline, as determined by VAS (0- 10).
研究概览
简要总结
A topical solution formulation of diclofenac has been developed for site specific application in acute musculoskeletal conditions like trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains and strains, localized forms of soft tissue rheumatism, osteoarthritis of superficial joints such as the knee, etc. This topical formulation has been designed with a higher strength of 2.32% w/v diclofenac diethyl ammonium (equivalent to diclofenac sodium 2% w/ v), an added absorption enhancer, and is supplied in roll on bottles. The current study aims to determine the efficacy and safety of diclofenac topical solution in comparison with topical diclofenac gel in acute painful musculoskeletal conditions.
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 Day(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or females patients aged 18- 70 years.
- •2.Patients with acute low back ache (non- specific) or pain and inflammation following trauma to muscles/ tendons/ ligaments/ joints (due to strains, sprains, stress, soft tissue injuries or blunt sports injuries) for not more than 2 days.
- •3.Patients with at least moderate pain of VAS greater than or equals to 4.
排除标准
- •1.Patients below 18 years or above 70 years of age.2.Hypersensitivity to aspirin/ NSAID or any other component of the formulation3.Any contraindication to diclofenac / NSAIDs4.Patients with skin wounds, open injuries or other conditions of broken skin at the site of proposed application5.Concomitant skin disease at site of application6.Use of another topical product at application site7.Pregnant women and lactating mothers8.Women of child bearing age not practicing or not willing to use contraceptive9.Unwilling patients.
- •10.Patients already on oral NSAIDs/ analgesics.11.Patients requiring hospitalization or other treatment for pain.
结局指标
主要结局
Improvement in pain intensity from baseline, as determined by VAS (0- 10).
时间窗: At the end of day 3 and day 7
次要结局
- Need for rescue analgesic(On 3rd and 7th day.)
- Pain intensity at rest and on passive movement(On 1st, 3rd and 7th day.)
- Degree of local signs (swelling, tenderness)(On 1st, 3rd and 7th day.)
- Degree of functional impairment(On 1st, 3rd and 7th day.)
- Global assessment by Physician and patients(At the end of study (7th day))
- No. of adverse event, No. of patients with adverse events(On 3rd and 7th day.)