Clinical Study on Fixed Dose Combination of S-Etodolac and Thiocolchicoside Tablet

Phase 3

Completed

• Registration Number: CTRI/2010/091/001223
• Lead Sponsor: Emcure Pharmaceuticals Ltd.Pune, India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1.Patients aged between 18 to 65 years of age providing written informed consent.
2.Nonspecific low back pain with an acute episode of recent onset (<72 hours) defined by average pain within the last 24 hours equal or more than 50 mm on the Visual Analogue Scale (VAS).

Exclusion Criteria

1.Known or suspected hypersensitivity to S-Etodolac, Etodolac, Diclofenac, Thiocolchicoside or any NSAIDs.
2.Low back pain due to vertebral collapse or of no mechanical origin (suspected by history taking and physical examination), such as neoplasm, infection or inflammatory disorders.
3.History of inflammatory arthritis of large joints.
4.History of seizure disorders.
5.History of malignancy.
6.Treatment with steroidal agents during the two days prior to prospective inclusion, prolonged use of corticosteroids.
7.Treatment with NSAIDs or muscle relaxant or opioid analgesics within last 3 days.
8.Clinically significant hepatic / renal dysfunction
9.Patients who have received other therapy (physiotherapy, physical manipulations, invasive intervention, acupuncture therapy) within the last 48 hours.
10.Uncontrolled hypertension (SBP>140 mmHg or DBP >90 mmHg), cardiac failure, past history of stroke / myocardial infarction.
11.History of active peptic ulcer or gastrointestinal (GI) bleeding, history of gastric pain with NSAIDs, history of any bleeding / blood coagulation disorder.
12.History of NSAID/aspirin-induced asthma.
13.Pregnancy, lactation or women of childbearing potential not using efficient contraception.
14.History of alcohol / drug abuse.
15.Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Responder RateTimepoint: Day 0 and day 5

Secondary Outcome Measures

Name	Time	Method
1. Improvement in paravertebral muscle spasm<br>2. Improvement in VAS score<br>3. Percent decrease in hand-to-floor distance<br>4. Global evaluation assessed at the end of treatmentTimepoint: Day 0 and day 5