None listed
Conditions
Interventions
Intervention1: A FDC of Lornoxicam 4mg + Chlorzoxazone 250mg: Lornoxicam 4mg + Chlorzoxazone 250mg,TID, Duration one week
Control Intervention1: Lornaxicam 4mg: Lornaxicam 4mg,TID, Duration one week
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactB Mohan Reddy
NIMS
Outcome results
None listed