ornoxicam + Chlorzoxazone Tablets in the treatment of Acute Musculoskeletal Pain.
- Registration Number
- CTRI/2010/091/000009
- Lead Sponsor
- Hetero Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 240
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy outcome will be Change in pain rating, tenderness and pain relief from baseline to end of the study (0-7days)Timepoint: 0,3 & 7 days
- Secondary Outcome Measures
Name Time Method 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 studyTimepoint: 0,3 & 7 days