A Prospective, Multicentric, Post Marketing Surveillance to Evaluate Efficacy & Safety of Ranitidine HCl (150 & 300 mg IR/CR) in Indian Patients with Gastroesophageal Reflux Disease (PROGRADE)

Purpose: Ranitidine hydrochloride (HCl) remains an important medication for treating acid-peptic ailments such as Gastroesophageal reflux disease (GERD). The main objective of this Post Marketing Surveillance (PMS) clinical study was to test the efficacy and safety HCl in Indian patients suffering from GERD. Patients Methods: Data 2446 (1307 males; 1121 females) 21 centers across India were analyzed. received either three treatments: 150 mg twice a day (BID) (ARM-A), 300 once daily (OD) or BID (ARM-B), OD (ARM-C). Reflux Disease Symptom Assessment Scale (GSAS) score Heartburn Severity used assess drug’s efficacy. adverse events reported by investigators analyzed profile Ranitidine. Results: Of subjects screened, 2428 enrolled. There significant reduction GSAS scores baseline end visit all ARMs. reduced 2.02 0.23 ARM-A, 2.01 0.24 ARM-B, 2.07 0.26 ARM-C patients. In ARM A, 72.82% had 24 hours heartburn-free days, 66.89% 7 consecutive which more than other two 128 (5.27%) ADRs due at different doses. most frequently ADR constipation (17.18%), followed oliguria (14.06%), cold (13.28%), dysuria (12.5%). ADRs, 113 (88.28%) mild, only 11 (8.59%) related drug. No severe during study. Conclusion: 150/300 tablet found be effective safe H2-receptor antagonist GERD Patients.