Ranitidine Hydrochloride (Page 2 of 5)

Clinical Trials

Active Duodenal Ulcer

In a multicenter, double-blind, controlled, US study of endoscopically diagnosed duodenal ulcers, earlier healing was seen in the patients treated with ranitidine as shown in Table 3:

Table 3: Duodenal Ulcer Patient Healing Rates
Ranitidine* Placebo*
Number Healed/ Number Healed/
Entered Evaluable Entered Evaluable
* All patients were permitted p.r.n. antacids for relief of pain.
P <0.0001
Outpatients
Week 2 69/182 31/164
(38%) (19%)
195 188
Week 4 137/187 76/168
(73%) (45%)

In these studies patients treated with ranitidine reported a reduction in both daytime and nocturnal pain, and they also consumed less antacid than the placebo-treated patients.

Table 4: Mean Daily Doses of Antacid
Ulcer Healed Ulcer Not Healed
Ranitidine 0.06 0.71
Placebo 0.71 1.43

Foreign studies have shown that patients heal equally well with 150 mg b.i.d. and 300 mg h.s. (85% versus 84%, respectively) during a usual 4-week course of therapy. If patients require extended therapy of 8 weeks, the healing rate may be higher for 150 mg b.i.d. as compared to 300 mg h.s. (92% versus 87%, respectively). Studies have been limited to short-term treatment of acute duodenal ulcer. Patients whose ulcers healed during therapy had recurrences of ulcers at the usual rates.

Maintenance Therapy in Duodenal Ulcer

Ranitidine has been found to be effective as maintenance therapy for patients following healing of acute duodenal ulcers. In 2 independent, double-blind, multicenter, controlled trials, the number of duodenal ulcers observed was significantly less in patients treated with ranitidine (150 mg h.s.) than in patients treated with placebo over a 12-month period.

Table 5: Duodenal Ulcer Prevalence
Double-blind, Multicenter, Placebo-Controlled Trials
Multicenter Number of
Trial Drug Duodenal Ulcer Prevalence Patients
0-4 0-8 0-12
Months Months Months
%=Life table estimate
* =P <0.05 (Ranitidine versus comparator).
RAN=ranitidine
PLC=placebo
USA RAN 20%* 24%* 35%* 138
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
Ranitidine* Placebo*
Number Healed/ Number Healed/
Entered Evaluable Entered Evaluable
* All patients were permitted p.r.n. antacids for relief of pain.
P =0.0009
Outpatients
Week 2 16/83 10/83
(19%) (12%)
92 94
Week 6 50/73 35/69
(68%) (51%)

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

Maintenance of Healing of Gastric Ulcers

In 2 multicenter, double-blind, randomized, placebo-controlled, 12-month trials conducted in patients whose gastric ulcers had been previously healed, ranitidine 150 mg h.s. was significantly more effective than placebo in maintaining healing of gastric ulcers.

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