Clinical study to evaluate the efficacy and tolerability of FDC of S(+)-Etodolac and Paracetamol Tablet in acute musculoskeletal pain

Phase 3

• Conditions: Acute musculoskeletal pain

• Registration Number: CTRI/2009/091/000720
• Lead Sponsor: Emcure Pharmaceuticals Ltd, Pune

Brief Summary

This multicentric randomized, comparative clinical trial is proposed to assess the efficacy and tolerability of FDC of S-Etodolac (300 mg) and Paracetamol (500 mg) tablet in acute musculoskeletal pain. The secondory objective of the study is to compare the efficacy and tolerability of FDC of S-Etodolac (300 mg) and Paracetamol (500 mg) tablet with FDC of Diclofenac (50 mg) and Paracetamol (500 mg) tablet in acute musculoskeletal pain. Patients visiting the OPDs for acute musculoskeletal pain will be enrolled in this study. After satisfing exclusion and inclusion criteria, 100 patients with acute musculoskeletal pain will be enrolled in the study. Each enrolled patient will receive treatment with either FDC of S-Etodolac (300 mg) and Paracetamol (500 mg) tablet twice daily OR with FDC of Diclofenac (50 mg) and Paracetamol (500 mg) tablet thrice daily. Each treatment will be administered for three consecutive days. Patients will be evaluated on baseline and after three days of therapy for pain intensity and pain relief score. Safety variables will be Patient's global assessment about the tolerability of the drug. Any Adverse event repored will be recorded.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. Male or female patients between 18-65 years of age.2) Patients having acute musculoskeletal pain e.g. musculoskeletal injuries, myalgia, neck pain, limb pain, low back pain, joint pain, widespread musculoskeletal pain3) Patients willing to give written informed consent and willing to comply with trial protocol.

Exclusion Criteria

1. Patients previously sensitive to S-Etodolac, to diclofenac, to paracetamol, to any other NSAID, or to any of the ingredients of the product2) Patients in whom substances with a similar action (e.g. Aspirin, or other NSAIDs) precipitate attacks of asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic oedema.3) Patients with active or suspected gastrointestinal ulcer or history of gastrointestinal ulcer or chronic dyspepsia.4) Patients who have gastrointestinal bleeding or other active bleedings or bleeding disorders.5) Patients with Crohn?s disease or ulcerative colitis.6) Patients with a history/ presence of bronchial asthma.7) Patients with severe heart failure8) Patients with moderate to severe renal dysfunction9) Patients with severely impaired hepatic function10) Patients with hemorrhagic diathesis and other coagulation disorders11) Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception12) Treatment with other analgesic and/or anti-inflammatory agent13) Patients who will receive some other drug during the study besides that in the protocol that could alter the bioavailability of the study drug 14) Any condition that, in the opinion of the investigator, does not justify the patient's inclusion in the study.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Responder rate	Baseline, after 3 days of therapy

Secondary Outcome Measures

Name	Time	Method
1) Sum of analogue pain intensity differences (SAPID) on visual analogue scale (VAS).2)Sum of pain intensity differences (SPID) on categorical verbal scale (VS).3) Total pain relief score (TOTPAR) on VS. 4)Patient?s global assessment of the efficacy of the drug5)Physician?s global assessment of the efficacy of the drug	Baseline and after 3 days of therapy
1) Patient's global assessment about the tolerability of the drug 2) Any adverese events will be noted.	After 3 days of therapy

Trial Locations

Locations (10)

Chowdry Orthopaedic Centre; 🇮🇳 Bangalore, KARNATAKA, India

Dr. Gurpreet Dhingra; 🇮🇳 Mumbai, MAHARASHTRA, India

Hardikar Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Jaynagar General Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Panse Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Pune Institute of Accident and Orthopedics; 🇮🇳 Pune, MAHARASHTRA, India

Ram Krishna Mission Hospital; 🇮🇳 Varanasi, UTTAR PRADESH, India

RITTIK (Clinic & Laboratory); 🇮🇳 Kolkata, WEST BENGAL, India

Shri Guruji Rugnalaya; 🇮🇳 Nashik, MAHARASHTRA, India

Yogesh Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Chowdry Orthopaedic Centre

🇮🇳Bangalore, KARNATAKA, India

Dr. C. M. Azhar Almas

Principal investigator

azharalmas@yahoo.com