A Study to Evaluate the Efficacy and Safety of fixed dose combination of Etoricoxib(60mg) and Thiocolchicoside (4mg) in patients with Low Back Pain.

Phase 4

• Conditions: Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue

• Registration Number: CTRI/2022/07/043690
• Lead Sponsor: MANKIND PHARMA LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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

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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 <br/ ><br>between the two arms. <br/ ><br>2. Mean change in 24 item Oswestry disability index (ODI) scores from baseline to week <br/ ><br>4 and compared between the two arms. <br/ ><br>Timepoint: Baseline to week 4 <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1. Mean change in Wong Bakers Face Pain Scale from baseline to week 2 and compared <br/ ><br>between the two arms. <br/ ><br>2. Mean change in Oswestry disability index (ODI) scores from baseline to week 2 and <br/ ><br>compared between the two arms. <br/ ><br>Timepoint: Baseline (D0) to week 2 (D14)