A double‐blind, placebo‐controlled study of the efficacy and safety of non‐prescription ranitidine 75 mg in the prevention of meal‐induced heartburn

• Published in: Alimentary pharmacology & therapeutics Vol. 13; no. 4; pp. 467 - 473
• Main Authors: PAPPA, K. A, WILLIAMS, B. O, PAYNE, J. E, BUARON, K. S, MUSSARI, K. L, CIOCIOLA, A. A
• Format: Journal Article
• Language: English
• Published: Oxford UK Blackwell Science Ltd 01.04.1999; Blackwell
• Subjects: Adult; Anti-Ulcer Agents - administration & dosage; Anti-Ulcer Agents - adverse effects; Anti-Ulcer Agents - therapeutic use; Biological and medical sciences; Digestive system; Double-Blind Method; Female; Food - adverse effects; Heartburn - prevention & control; Humans; Male; Medical sciences; Nonprescription Drugs; Pharmacology. Drug treatments; Ranitidine - administration & dosage; Ranitidine - adverse effects; Ranitidine - therapeutic use; Treatment Outcome; Human; Gastroesophageal reflux; Chemoprophylaxis; Postprandial; Esophageal disease; Antiulcer agent; Antihistaminic; Posology; Efficiency; Ranitidine; Digestive diseases; Antagonist; Comparative study; H2 Histamine receptor
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1046/j.1365-2036.1999.00505.x

Background : Ranitidine 75 mg (Zantac 75) has been shown to be effective for the treatment of pre‐existing heartburn symptoms. Aim : To compare the efficacy of dosing ranitidine 75 mg or placebo 30 min prior to a proven heartburn‐provoking meal in completely preventing or reducing subsequent heartburn symptoms. Methods : A randomized, double‐blind, parallel methodology was used at nine investigative centres. Following a screening visit, patients ate a standard test meal consisting of chilli, chips and a soft drink on two occasions. On the first occasion, patients received single‐blind placebo 30 min before the meal. This meal was used to qualify patients and to ensure the onset of a minimum level of heartburn. Patients who qualified were randomized (n = 284) to receive double‐blind ranitidine 75 mg or placebo 30 min before a second test meal administered 4–14 days later at the treatment visit. Patients recorded whether heartburn was present and rated heartburn severity by completing visual analogue scales at 15‐min intervals over the 4.5 h meal evaluation periods. Results : Statistically significant differences favouring ranitidine 75 mg were determined for complete prevention of heartburn (P < 0.006), heartburn severity area under the curve (P < 0.001), a clinical success end‐point (P < 0.001), and all other end‐points (P < 0.001). Conclusions : These data clearly demonstrate that ranitidine 75 mg is effective in completely preventing or decreasing heartburn when administered 30 min prior to a provocative meal.