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Pediatric

Pediatric Studies for the Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD)

Treatment of Symptomatic GERD

The effectiveness of PRILOSEC® for the treatment of symptomatic GERD in pediatric patients 1 to 16 years of age is based in part on data obtained from 125 pediatric patients in two uncontrolled clinical studies.

The first study enrolled 12 pediatric patients 1 to 2 years of age with a history of clinically diagnosed GERD. Patients were administered a single dose of omeprazole (0.5 mg/kg, 1 mg/kg, or 1.5 mg/kg) for 8 weeks as an open capsule in 8.4% sodium bicarbonate solution. Seventy-five percent (9/12) of the patients had vomiting/regurgitation episodes decreased from baseline by at least 50%.

The second study enrolled 113 pediatric patients 2 to 16 years of age with a history of symptoms suggestive of symptomatic GERD. Patients were administered a single dose of omeprazole (10 mg or 20 mg, based on body weight) for 4 weeks either as an intact capsule or as an open capsule in applesauce. Successful response was defined as no moderate or severe episodes of either pain-related symptoms or vomiting/regurgitation during the last 4 days of treatment. Results showed success rates of 60% (9/15; 10 mg omeprazole) and 59% (58/98; 20 mg omeprazole), respectively.

See also Use in Specific Populations.

Reference: PRILOSEC [package insert]. Zug, Switzerland: Covis Pharma; 2017

Adult

Symptomatic Gastroesophageal Reflux Disease (GERD)

A placebo-controlled study was conducted in Scandinavia to compare the efficacy of omeprazole 20 mg or 10 mg once daily for up to 4 weeks in the treatment of heartburn and other symptoms in GERD patients without erosive esophagitis. Results are shown below.

% Successful Symptomatic Outcome1

  PRILOSEC® 20 mg a.m. PRILOSEC® 10 mg a.m. Placebo a.m.
All patients 462,3 (n=205) 313 (n=199) 13 (n=105)
Patients with confirmed GERD 562,3 (n=115) 363 (n=109) 14 (n=59)

1. Defined as resolution of heartburn; 2. (P<0.005) versus 10 mg; 3. (P<0.005) versus placebo

See also Use in Specific Populations.

Reference: PRILOSEC [package insert]. Zug, Switzerland: Covis Pharma; 2017