Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue
Conditions
Interventions
Intervention1: Etoricoxib(60mg) and Thiocolchicoside (4mg): To be administered orally, once daily
in the morning for a period of 4 weeks.
Control Intervention1: Chlorzoxazone(500mg) and Diclofenac(50
Sponsors
MANKIND PHARMA LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects of either sex in the age range of 18-70 years (both age inclusive) with a history of LBP and muscle spasm of �14 days, with a Wong Bakers Faces Pain scale score >4 2. Willing to give written informed consent and comply with study procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects with back pain due to fractures, malignancy, infection, abnormal metabolism, osteoarthritis of hip or any other disease, 2. Back pain originating or referred from other organs, 3. Subjects with a history of peptic ulceration or gastrointestinal bleeding or severe dyspepsia, MC/BRT/21-002 Version: 1.0 dated 03 Feb 2022 Confidential Page 21 of 40 4. Subjects with known allergy to NSAIDs and skeletal muscle relaxants or any component of the study product 5. Subjects suffering from asthma or other allergic disorders, 6. Subjects with severe comorbid systemic disease including bleedings diathesis, currently on anticoagulation therapy, hepatic or renal impairment, clinically significant cardiac disease, neurological disease, or psychiatric disorder 7. Pregnant or lactating women 8. History or evidence of spinal disease (eg, ankylosing spondylitis, rheumatoid arthritis, tumor, and Paget disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean change in Wong Bakers Face Pain Scale from baseline to week 4 and compared between the two arms. 2. Mean change in 24 item Oswestry disability index (ODI) scores from baseline to week 4 and compared between the two arms. Timepoint: Baseline to week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in Wong Bakers Face Pain Scale from baseline to week 2 and compared between the two arms. 2. Mean change in Oswestry disability index (ODI) scores from baseline to week 2 and compared between the two arms. Timepoint: Baseline (D0) to week 2 (D14) | — |
Countries
India
Contacts
Public ContactDr Rajat Singhal
Mankind Pharma
Outcome results
None listed