Comparative, Randomized, Open Label, Parallel, Multicentric study for Efficacy and Safety of Lornoxicam + Chlorzoxazone versus Lornoxicam in the Management of Acute Musculoskeletal Pain.

Hetero Labs Limited16 个研究点分布在 1 个国家目标入组 240 人开始时间: 待定

试验速览

阶段: 3 期
发起方: Hetero Labs Limited
入组人数: 240
试验地点: 16
主要终点: The primary efficacy outcome will be Change in pain rating, tenderness and pain relief from baseline to end of the study (0-7days)

This is a Comparative, Randomized, Open Label, Parallel, Multicentric study for Efficacy and Safety of Lornoxicam + Chlorzoxazone versus Lornoxicam in the Management of Acute Musculoskeletal Pain. 2. The proposed number of subject to be enrolled in to the study is 300 (this number includes the expected no. of dropouts) and data will be submitted 240 completed patients. Study population will comprise of Patients with Acute Musculoskeletal Pain. 3. The recommended dose of Lornoxicam in dose of 4mg + Chlorzoxazone in dose of 250mg in comparison with Lornoxicam in the dose of 4mg thrice daily for one week. 4. The primary efficacy outcome will be Change in pain rating, tenderness and pain relief from baseline to end of the study and the secondary efficacy outcome is to evaluate of the safety by assessing the laboratory parameters, treatment emergent adverse events, and overall response of the patient & investigator at the end of the study.

•a)Male or female patients, b)Between 20-65 years of age, c)Willing to give written informed consent and willing to comply with trial protocol.
•d)Out patients with diagnosis of cervical spondylosis.
•e) Patients with at least 40 mm pain rating on VAS scale.
•f) Patient and / or physician?s global assessment of arthritic condition as fair, poor or very poor.
•g)Patients not on any anti-inflammatory or other therapy in the past 2 weeks known to affect the study outcome.

•a) Pregnant and lactating women b) Patients with H/O any drug allergy c) Unwilling to comply with the protocol requirements d) Patients with gastro-intestinal disease, peptic ulcer, bleeding disorder and fecal blood loss.
•e) Patients with cardiac, hepatic, renal dysfunction and haemopoetic disorder f) Patients with hypertension g) Patients deemed ineligible by the investigator h)H/O skin lesions, skin ulcers.

The primary efficacy outcome will be Change in pain rating, tenderness and pain relief from baseline to end of the study (0-7days)

时间窗: 0,3 & 7 days

The Secondary outcome is to evaluate safety by assessing the laboratory parameters, treatment emergent adverse events, and overall response of the patient & investigator at the end of the study(0,3 & 7 days)

发起方

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