A Clinical Study to Evaluate the Efficacy and Safety of FDC of Chlorzoxazone 500 mg, Diclofenac Potassium 50 mg, Paracetamol 325 mg Tablets for the treatment of Acute Musculoskeletal Spasm.

Phase 4

Completed

• Conditions: Health Condition 1: M628- Other specified disorders of muscle

• Registration Number: CTRI/2023/08/056872
• Lead Sponsor: G S Pharmabutor Pvt Ltd Co Win Medicare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-03-04
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1.Male/Female patients aged between 18-65 years with a clinical diagnosis of acute musculoskeletal spasm.

2. Muscle Spasm persistent since last 24 hours at the time of presentation to the investigator.

3.Patients with at least moderate pain at rest of Numeric rating Scale (NRS) greater or equal to 4.

4.Patient with presence of muscle spasm scoring greater than 1

5.Willingness to comply with the study schedule and procedures.

6.Patient is willing to provide written informed consent prior to study.

Exclusion Criteria

1.Pregnant and Lactating mothers.

2.Patients with painful muscle spasms that require parenteral therapy/ surgery/ hospital admission for management.

3.Patient history suggestive of any degenerative/autoimmune/nervous system related disease conditions.

4.Use of any oral or topical analgesic or anti-inflammatory medicine 48 hours prior to development of acute musculoskeletal spasm.

5.Patients with history of severe cardiac/hepatic/gastrointestinal/ pulmonary impairment.

6.Known hypersensitivity to any ingredient of the study drug.

7.Concomitant Participation in any other clinical trial or in last 90 days.

8.History of regular fever, headache or any other disease that warrants frequent use of Paracetamol or NSAIDS.

9.Patients with any condition which in opinion of the investigator makes the patient unsuitable for inclusion.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Pain intensity at rest Based on NRS Baseline to day 3 and day 5 <br/ ><br>•Pain intensity on passive movement Based on NRS Baseline to day 3 and day 5 <br/ ><br>• Physicians and Patient Global Assessment Scale Day 3 and day 5 <br/ ><br>• Muscle Spasm Scoring Baseline to day 3 and day 5 <br/ ><br>Timepoint: Day 01, Day 03 and Day 05

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety & tolerability of Chlorzoxazone 500 mg, Diclofenac Potassium 50 mg, Paracetamol 325 mg Tablets compared to FDC of Diclofenac Potassium 50 mg & Paracetamol 325 mg in patients with acute musculoskeletal spasm. <br/ ><br>• Number of patients with any drug related treatment emergent adverse events TEAEs. Time frame up to day 5 <br/ ><br>• Number of patients with TEAEs Time Frame up to day 5 <br/ ><br>• Number of patients with serious TEAEs, STEAEs Time Frame up to Week 12 <br/ ><br>• Intensities of TEAE & STEAE <br/ ><br>• Changes in laboratory parameters CBC, SGOT, SGPT, Serum Creatinine, Bilirubin <br/ ><br>Timepoint: Day 01, Day 03 & Day 05