A Study to Evaluate the Efficacy and Safety of fixed dose combination of Etoricoxib(60mg) and Thiocolchicoside (4mg) in patients with Low Back Pain.
- Conditions
- Diseases of the musculoskeletal system and connective tissue,
- Registration Number
- CTRI/2022/07/043690
- Lead Sponsor
- MANKIND PHARMA LTD
- Brief Summary
This study is designed as a Prospective, Randomized, Parallel Group, Open Label, Multi-centric, Active Controlled Study to Evaluate the Efficacy and Safety of fixed dose combination of Etoricoxib(60mg) +Thiocolchicoside (4mg) vs Chlorzoxazone(500mg) +Diclofenac(50mg) +Paracetamol(325mg) in Low Back Pain. The Primary objective is to evaluate the efficacy of fixed dose combination of Etoricoxib(60mg) +Thiocolchicoside (4mg) vs Chlorzoxazone(500mg) +Diclofenac(50mg) +Paracetamol(325mg) in low back pain post 4 weeks of treatment.
Subjects will be recruited from out-patient departments of study sites. On the randomization visit of Day 0 a written informed consent will be obtained from subjects fulfilling the inclusion/exclusion criteria described in the study protocol. In cases of subjects who have taken NSAIDs or muscle relaxants during the last 3 days a washout period (minimum 2 days for all medications that have an elimination half-life of less than 10 hours or at least 5 times the elimination half-life for medications with longer half-lives1 ). An initial or baseline pain assessment (the day of randomization prior to dosing) will be recorded. Subjects will undergo a physical examination. Subjects will be instructed to fill the Wong Bakers Face Pain Scale and Oswestry disability index (ODI) Subjects will be randomized to one of the two arms as per predefined randomization list. Subject diary will be provided to all enrolled subjects. Baseline laboratory investigations (Complete Hemogram, Liver function and renal function test) will be performed. Subjects will be contacted telephonically at Day 14 and enquired about drug compliance, relief of low back pain and occurrence of any adverse event. At end of study visit subjects will be evaluated physically at site. A complete physical examination will be carried out (Finger to floor distance/ Lasegue’s manuevre). Subjects will be guided to fill the Wong Bakers Face Pain Scale and Oswestry disability index (ODI) for study end assessment. Subject diary will be reviewed. IP compliance will be checked and adverse events experienced would be evaluated. End of study laboratory investigations will be carried out.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Mean change in Wong Bakers Face Pain Scale from baseline to week 4 and compared Baseline to week 4 between the two arms. Baseline to week 4 2. Mean change in 24 item Oswestry disability index (ODI) scores from baseline to week Baseline to week 4 4 and compared between the two arms. Baseline to week 4
- Secondary Outcome Measures
Name Time Method 1. Mean change in Wong Bakers Face Pain Scale from baseline to week 2 and compared between the two arms.
Trial Locations
- Locations (2)
IPGMER and SSKM Hospital
🇮🇳Kolkata, WEST BENGAL, India
Maulana Azad Medical College
🇮🇳Delhi, DELHI, India
IPGMER and SSKM Hospital🇮🇳Kolkata, WEST BENGAL, IndiaDr Arnab KarmakarPrincipal investigator9830401377arnab.doctor@gmail.com