Revise Phase IV clinical trial protocol of Nimesulide Granules for oral suspension: CDSCO Panel Tells Dr Reddys
New Delhi: The Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has recommended the drug major Dr. Reddy's Laboratories revise the Phase IV clinical trial protocol of Nimesulide Granules for oral suspension of 100mg in accordance with the number of study centers, where the study is to be conducted and exclusion criteria.
This came after the firm presented the proposal for a grant of permission to conduct a Phase IV clinical trial for Nimesulide Granules for oral suspension 100 mg indicated for the treatment of inflammatory conditions including joint disorders such as Rheumatoid Arthritis, post-traumatic and post–operative painful conditions, and fever.
Nimesulide is a nonsteroidal anti-inflammatory drug (NSAID) of the sulfonamide class. Nimesulide is a non-steroidal anti-inflammatory drug (NSAID). It works by blocking the release of certain chemical messengers that cause pain and inflammation (redness and swelling).
The therapeutic effects of Nimesulide are the result of its complete mode of action which targets a number of key mediators of the inflammatory process such as COX-2-mediated prostaglandins, free radicals, proteolytic enzymes, and histamine.
At the recent SEC meeting for Analgesic & Rheumatology held on 7th June 2023, the expert panel reviewed the proposal presented by Dr. Reddy's Laboratories for the grant of permission to conduct a Phase IV clinical trial of Nimesulide Granules for oral suspension 100 mg indicated for the treatment of inflammatory conditions including joint disorders such as Rheumatoid Arthritis, post-traumatic and post–operative painful conditions, and fever.
After detailed deliberation, the committee made the following recommendations:
1. The firm should mention the no. of study centers and where the study is to be conducted.
2. In the Exclusion criteria it is mentioned that Patients are detected with / suffering from any major organ system disorder as per the physician’s clinical discretion, hence it should be clearly specified which organ system or condition they are excluding.
Accordingly, the expert panel suggested that the firm should submit the revised protocol to CDSCO for further review by the committee.
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