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

Phase 3

Completed

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

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) 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 pain
3) 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 product
2) 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 failure
8) Patients with moderate to severe renal dysfunction
9) Patients with severely impaired hepatic function
10) Patients with hemorrhagic diathesis and other coagulation disorders
11) Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception
12) Treatment with other analgesic and/or anti-inflammatory agent
13) 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: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Responder rateTimepoint: Baseline, after 3 days of therapy

Secondary Outcome Measures

Name	Time	Method
1) Patient&#039;s global assessment about the tolerability of the drug 2) Any adverese events will be noted.Timepoint: After 3 days of therapy;1) Sum of analogue pain intensity differences (SAPID) on visual analogue scale (VAS).<br>2)Sum of pain intensity differences (SPID) on categorical verbal scale (VS).<br>3) Total pain relief score (TOTPAR) on VS. <br>4)Patient?s global assessment of the efficacy of the drug<br>5)Physician?s global assessment of the efficacy of the drugTimepoint: Baseline and after 3 days of therapy