New Delhi: In response to the proposal to conduct a Phase III clinical trial presented by the drug major Reddy’s Laboratories, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the firm to revise the protocol of Phase III clinical trial of the drug Tegoprazan with respect to the exclusion criteria number 15 &18 to specify that subject’s history of malignancy should be excluded in the study and exclusion of the subject from the study should be based on their previous medication half-lives or as per discretion of investigator.
This came after the firm presented the protocol to conduct the Phase III clinical trial titled “A multi-national, multi-centric, prospective, randomized, double-blind, active-controlled, parallel-group study to evaluate the efficacy and safety of Tegoprazan in patients with erosive gastroesophageal reflux disease” vide protocol no. DRL-IND-NDA08-TEG/2022; Version 1.0 dated 28-Oct-2022.
Tegoprazan is indicated for the treatment of erosive esophagitis (EE) and non-erosive reflux disease (NERD).
Tegoprazan works as a potassium-competitive acid blocker that is potent and highly selective. Its mechanism of action is different from that of the proton-pump inhibitors as this drug does not require conversion into an active form and can directly inhibit H+/K+‐ATPase in a reversible and K+‐competitive way. This is because it is an acid-resistant weak base with the ability to remain in the highly acidic canaliculi of gastric parietal cells.
At the recent SEC meeting for Gastroenterology and Hematology held on the 16th and 17th of March 2023, the expert panel reviewed the protocol presented by Reddy’s Laboratories to conduct the Phase III clinical trial of the drug Tegoprazan.
After detailed deliberation, the committee recommended to revise the protocol with respect to the exclusion criteria number 15 and18 to specify that the subject’s history of malignancy should be excluded from the study and exclusion of the subjects from the study should be based on their previous medication half-lives or as per discretion of the investigator.
Accordingly, the expert panel suggested the firm to submit revised protocol for further review by the committee.
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