Famotidine (Page 4 of 5)

14 Clinical Studies

14.1 Active Duodenal Ulcer

In a U.S. multicenter, double-blind trial in adult outpatients with endoscopically confirmed duodenal ulcer (DU), orally-administered Famotidine was compared to placebo. As shown in Table 4, 70% of patients treated with Famotidine 40 mg tablets at bedtime were healed by Week 4. Most patients DU healed within 4 weeks.

Patients not healed by Week 4 were continued in the trial. By Week 8, 83% of patients treated with Famotidine had healed DU, compared to 45% of patients treated with placebo. The incidence of DU healing with Famotidine was greater than with placebo at each time point based on proportion of endoscopically confirmed healed DUs. Trials have not assessed the safety of Famotidine in uncomplicated active DU for periods of more than 8 weeks.

Table 4: Patients with Endoscopically-Confirmed Healed Duodenal Ulcers

Famotidine Tablets

40mg at bedtime (N=89)

Famotidine Tablets

20mg twice daily (N=84)

Placebo

at bedtime (N=97)

Week 2 32%  a 38%  a 17%
Week 4 70% 67%  a 31%

a p<0.001 vs. placebo
In this study, time to relief of daytime and nocturnal pain was shorter for patients receiving Famotidine than for patients receiving placebo; patients receiving Famotidine also took less antacid than patients receiving placebo.

14.2 Active Gastric Ulcer

In both a U.S. and an international multicenter, double-blind trials in patients with endoscopically-confirmed active gastric ulcer (GU),
orally-administered Famotidine 40 mg at bedtime was compared to placebo. Antacids were permitted during the trials, but consumption was not significantly different between the Famotidine and placebo groups.

As shown in Table 5, the incidence of GU healing confirmed by endoscopy (dropouts counted as unhealed) with Famotidine was greater than placebo at Weeks 6 and 8 in the U.S. trial, and at Weeks 4, 6 and 8 in the international trial. In these trials, most Famotidine-treated patients healed within 6 weeks. Trials have not assessed the safety of Famotidine in uncomplicated active GU for periods of more than 8 weeks.

Table 5: Patients with Endoscopically-Confirmed Healed Gastric Ulcers

Famotidine

40mg at bedtime (N-74)

Placebo

at bedtime (N=75)

Famotidine

40mg at bedtime (N=149)

Placebo

at bedtime (N=145)

Week 4 45% 39% 47% a 31%
Week 6 66% a 44% 65% a 46%
Week 8 78% b 64% 80% a 54%

ap≤0.01 vs. placebo bp≤0.05 vs. placebo

Time to complete relief of daytime and nighttime pain was statistically significantly shorter for patients receiving Famotidine than for patients receiving placebo; however, neither trial demonstrated a statistically significant difference in the proportion of patients whose pain was relieved by the end of the trial (Week 8).

14.3 Symptomatic Gastroesophageal Reflux Disease (GERD)

Orally-administered Famotidine was compared to placebo in a U.S. trial that enrolled patients with symptoms of GERD and without endoscopic evidence of esophageal erosion or ulceration. As shown in Table 6, patients treated with Famotidine 20 mg twice daily had greater improvement in symptomatic GERD than patients treated with 40 mg at bedtime or placebo.

Table 6: Patients with Improvement of Symptomatic GERD (N=376)

Famotidine

20mg twice daily (N=154)

Famotidine

40mg at bedtime (N=149)

Placebo

at bedtime (N=73)

Week 6 82%  a 69% 62%

a p≤0.01 vs. placebo

14.4 Erosive Esophagitis Due to GERD

Healing of endoscopically-verified erosion and symptomatic improvement were studied in a U.S. and an international double-blind trials. Healing was defined as complete resolution of all erosions visible with endoscopy. The U.S. trial comparing orally-administered Famotidine 40 mg twice daily to placebo and orally administered Famotidine 20 mg twice daily showed a significantly greater percentage of healing of erosive esophagitis for Famotidine 40 mg tablets twice daily at Weeks 6 and 12 (Table 7).

Table 7: Patients with Endoscopic Healing of Erosive Esophagitis — U.S. Study (N=318)

Famotidine

40mg twice daily (N=127)

Famotidine

20mg twice daily (N=125)

Placebo

twice daily (N=66)

Week 6 48% a,b 32% 18%
Week 12 69% a,c 54% a 29%

a p0.01 vs. placebo b p0.01 vs. Famotidine tablets 20 mg twice daily
c p0.05 vs. Famotidine tablets 20 mg twice daily

As compared to placebo, patients in the U.S. trial who received Famotidine tablets had faster relief of daytime and nighttime heartburn, and a greater percentage of Famotidine-treated patients experienced complete relief of nighttime heartburn. These differences were statistically significant. In the international trial, when orally-administered Famotidine 40 mg tablets twice daily was compared to orally-administered ranitidine 150 mg twice daily, a statistically significantly greater percentage of healing of erosive esophagitis was observed with Famotidine 40 mg tablets twice daily at Week 12 (Table 8). There was, however, no significant difference in symptom relief among treatment groups.

Table 8: Patients with Endoscopic Healing of Erosive Esophagitis-International Study(N=440)

Famotidine

40mg twice daily

(N=175)

Famotidine

20mg twice daily

(N=93)

Ranitidine

150mg twice daily

(N=172)

Week 6 48% 52% 42%
Week 12 71%  a 68% 60%

a p≤0.05 vs ranitidine 150 mg twice daily

14.5 Pathological Hypersecretory Conditions

In trials of patients with pathological hypersecretory conditions such as Zollinger-Ellison Syndrome with or without multiple endocrine neoplasias, Famotidine significantly inhibited gastric acid secretion and controlled associated symptoms. Orally administered Famotidine dosages from 20 mg to 160 mg every 6 hours maintained basal acid secretion below 10 mEq/hour; initial dosages were titrated to the individual patient need and subsequent adjustments were necessary with time in some patients.

14.6 Risk Reduction of Duodenal Ulcer Recurrence

Two randomized, double-blind, multicenter trials in patients with endoscopically-confirmed healed DUs demonstrated that patients receiving treatment with orally-administered Famotidine 20 mg tablets at bedtime had lower rates of DU recurrence, as compared with placebo.


• In the U.S. trial, DU recurrence within 12 months was 2.4 times greater in patients treated with placebo than in the patients treated with Famotidine tablets. The Famotidine-treated 89 patients had a cumulative observed DU recurrence rate of 23%, compared to a 57% in the 89 patients receiving placebo (p<0.01).


• In the international trial, the cumulative observed DU recurrence within 12 months in the 307 Famotidine-treated patients was 36%, compared to 76% in the 325 patients who received placebo (p<0.01).

Controlled trials have not extended beyond one year.

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