Protocol doesn't address all aims of phase IV CT: CDSCO Panel Tells Sun Pharma Lab on Esomeprazole Dual Release Gastro Resistant Tablets

New Delhi: Citing that the proposed study protocol of Esomeprazole Dual Release GastroResistant Tablets 80mg does not address all the aims of the phase IV clinical trial, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Sun Pharma Laboratories to include the adequate method for assessment of long-term effect of drug by means of specific questionnaires or by pH metric study.

In addition to the above, the expert panel suggested the firm to add more study sites including at-least one government site.

This came after Sun Pharma Laboratories presented their proposal for grant of permission to conduct Phase-IV clinical trial of Esomeprazole Dual release gastro-resistant tablets 80mg along with Phase-IV clinical trial protocol before the Committee.

Esomeprazole is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach. Esomeprazole is used to treat conditions where there is too much acid in the stomach. It is used to treat duodenal and gastric ulcers, erosive esophagitis, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome, a condition wherein the stomach produces too much acid.

At the recent SEC meeting for gastroenterology and hepatology held on February 27, 2025, the expert panel reviewed the proposal presented by Sun Pharma Laboratories along with Phase-IV clinical trial protocol.

After detailed deliberation, the Committee opined that , the proposed protocol does not address all the aims of phase IV clinical trial such as sudden discontinuation of treatment, long term follow-up etc.

Additionally, the expert panel mentioned that the firm is required to include the adequate method for assessment of long-term effect of drug by means of specific questionnaires or by pH metry study. Further, it is recommended to add more study sites including at-least one government site.

Accordingly, the expert panel suggested that the firm should submit revised Phase-IV protocol preferably within one month to CDSCO for further review by the Committee.

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