Revise Phase IV clinical trial protocol of Nimesulide Granules for oral suspension: CDSCO Panel Tells Dr Reddys

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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