Ranitidine Hydrochloride (Page 3 of 6)

Maintenance Therapy in Duodenal Ulcer

Ranitidine has been found to be effective as maintenance therapy for patients following healing of acute duodenal ulcers. In two independent, double-blind, multicenter, controlled trials, the number of duodenal ulcers observed was significantly less in patients treated with ranitidine (150 mg at bedtime) than in patients treated with placebo over a 12-month period.

Table 5. Duodenal Ulcer Prevalence
RAN = ranitidine.
% = Life Table estimate.
P <0.05 (Ranitidine versus comparator).
PLC = placebo.
Double-blind, Multicenter, Placebo-Controlled Trials


Drug Duodenal Ulcer Prevalence

No. of







RAN * 20% 24% 35% 138
USA PLC § 44% 54% 59% 139
RAN * 12% 21% 28% 174
Foreign PLC § 56% 64% 68% 165

As with other H2 -antagonists, the factors responsible for the significant reduction in the prevalence of duodenal ulcers include prevention of recurrence of ulcers, more rapid healing of ulcers that may occur during maintenance therapy, or both.

Gastric Ulcer

In a multicenter, double-blind, controlled, US study of endoscopically diagnosed gastric ulcers, earlier healing was seen in the patients treated with ranitidine as shown in Table 6.

Table 6. Gastric Ulcer Patient Healing Rates
All patients were permitted antacids as needed for relief of pain.
P = 0.009.
Ranitidine * Placebo *














Week 6



In this multicenter trial, significantly more patients treated with ranitidine became pain free during therapy.

Maintenance of Healing of Gastric Ulcers

In two multicenter, double-blind, randomized, placebo-controlled, 12-month trials conducted in patients whose gastric ulcers had been previously healed, ranitidine tablets or ranitidine capsules 150 mg at bedtime were significantly more effective than placebo in maintaining healing of gastric ulcers.

Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome)

Ranitidine inhibits gastric acid secretion and reduces occurrence of diarrhea, anorexia, and pain in patients with pathological hypersecretion associated with Zollinger-Ellison syndrome, systemic mastocytosis, and other pathological hypersecretory conditions (e.g., postoperative, “short-gut” syndrome, idiopathic). Use of ranitidine was followed by healing of ulcers in 8 of 19 (42%) patients who were intractable to previous therapy.

Gastroesophageal Reflux Disease (GERD)

In two multicenter, double-blind, placebo-controlled, 6-week trials performed in the United States and Europe, ranitidine 150 mg two times a day was more effective than placebo for the relief of heartburn and other symptoms associated with GERD. Ranitidine-treated patients consumed significantly less antacid than did placebo-treated patients.

The US trial indicated that ranitidine 150 mg two times a day significantly reduced the frequency of heartburn attacks and severity of heartburn pain within 1 to 2 weeks after starting therapy. The improvement was maintained throughout the 6-week trial period. Moreover, patient response rates demonstrated that the effect on heartburn extends through both the day and night time periods.

In two additional US multicenter, double-blind, placebo-controlled, 2-week trials, ranitidine 150 mg two times a day was shown to provide relief of heartburn pain within 24 hours of initiating therapy and a reduction in the frequency and severity of heartburn.

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