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

Abstract

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 chili, 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.

• Authors: K A Pappa, B O Williams, J E Payne, K S Buaron, K L Mussari, A A Ciociola
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 13 Issue 4 Pg. 467-73 (Apr 1999) ISSN: 0269-2813 [Print] England
• PMID: 10215730 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Ulcer Agents
• Nonprescription Drugs
• Ranitidine

Topics

• Adult
• Anti-Ulcer Agents (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Food (adverse effects)
• Heartburn (prevention & control)
• Humans
• Male
• Nonprescription Drugs
• Ranitidine (administration & dosage, adverse effects, therapeutic use)
• Treatment Outcome