Tolia V et al.69
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Lansoprazole 15 or 30 mg, eight to 12 weeks |
Open, multicentric Phase I/II study |
Children aged 1 to 11 years n = 66 |
Considered safe and well tolerated 78% healed EE in week eight, and 100% in week 12 |
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AE: headache, constipation. |
Gremse D et al. 70
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Lansoprazole 15 or 30 mg Studies carried out five days after beginning of use |
Open, multicentric Phase I/II study Pharmacokinetics and dynamics |
Children aged 1 to 11 years n = 66 |
Pharmacokinetic properties similar to adults/lansoprazole increases mean intragastric pH in 24 hours and the % of time in which pH is above 3 or 4 |
Gunasekaran et al. 71
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Lansoprazole 15 or 30 mg Studies carried out five days after beginning of use |
Open, multicentric |
Adolescents aged 12 to 17 years |
Pharmacokinetic properties similar to adults/lansoprazole 15 mg or 30 mg 1x/day used for five days increases the intragastric pH, relieves symptoms, and is well tolerated |
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Phase I/II study |
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Pharmacokinetics and dynamics |
n = 63 |
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AE: allergies, diarrhea, rash, dizziness. |
Fiedorek S et al. 72
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Lansoprazole 15 or 30 mg eight weeks |
Open |
Adolescents aged 12 to 17 years |
Lansoprazole 15 and 30 mg reduced symptoms of adolescents with NERD and EE, respectively. Both doses were considered safe |
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Phase I/II study |
n= 64 NERD (15 mg) |
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Efficacy and safety |
n= 23 EE (30 mg) |
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AE: headache, abdominal pain, nausea and dizziness. |
Gold BD et al. 73
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Esomeprazole 20 and 40 mg Eight weeks |
Multicentric, randomized, and double-blinded non placebo-controlled |
Adolescents aged 12 to 17 years |
Esomeprazole decreased symptoms in both groups |
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n = 148 |
AE: headache, 8%; abdominal pain, 3%; nausea, 2%; diarrhea, 2%. No severe AE |
Orenstein SR et al. 53
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Lansoprazole four weeks |
Multicentric, double-blinded, parallel, placebo-controlled. |
Infants aged 1 to 12 months n = 162 |
54% of response in the two groups |
Tolia V et al.74
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Esomeprazole oral route 5 or 10 mg/day < 20 kg 10 or 20 mg/day > 20 kg 0.2 or 1 mg/kg/day Eight weeks |
Multicentric, randomized, parallel and double-blinded (for dose). |
1 to 11 yearsn = 109 |
GERD confirmed endoscopically or histologically |
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Healing of macro or microscopic erosive esophagitis |
Baker R et al. 75
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Pantoprazole delayed release oral suspension |
Multicentric, randomized, and double-blinded. |
1 to 5 years. n = 60 |
GERD confirmed endoscopically or histologically |
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0.3; 0.6 and 1.2 mg/kg |
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Improvement of symptoms |
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Eight weeks |
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AE did not increase with higher doses |
Winter et al.51
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Pantoprazole delayed-release oral granules |
Randomized, double-blinded, placebo-controlled (treatment and withdrawal) |
1 to 11 months n = 106 |
Patients with GERD symptoms |
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In blind phase, no differences between the withdrawal of pantoprazole or placebo due to lack of efficacy |
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1.2 mg/kg/day |
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Four weeks of pantoprazole and four weeks double-blind pantoprazole x placebo |
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Safe and well tolerated |
Tammara BK et al. 76
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Pantoprazole 0.6 mg/kg 1.2 mg/lg |
Multicentric, open, randomized. Pharmacokinetics |
Study 1 - 1 month to 12 months n = 43 |
Exposure increases with increasing dose, but there is great individual variation. |
Study 1 |
Oral granules |
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Study 2 - 1 year to < 6 years |
Exposure was similar to adults. |
Study 2 |
Measurements performed at least after five consecutive doses |
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n = 17 |
Well tolerated. |
Ward RM et al. 77
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Delayed-release pantoprazole tablets |
Multicentric, open, randomized. |
6 to 16 years. |
Patients with GERD have the same systemic exposure of adults. |
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20 or 40 mg/day |
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n = 38 |
No serious adverse effects. |
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Measurements performed 12 hours after a single dose and two to four hours after multiple doses |
Pharmacokinetics and safety |
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Sandström M et al. 78
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Esomeprazole IV 1x/day Four days |
Multicentric, open, randomized, Phase I |
0 to 17 years. |
Clearance increases with weight and age. |
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Well tolerated |
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31 patients with AE |
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Pharmacokinetics and tolerability IV |
n = 57 |
No severe AE |
Kukulka M et al. 79
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MR dexlansoprazole 30 or 60 mg for seven days |
Multicentric, parallel, open, Phase I Pharmacokinetics and safety |
2 to 17 years. n = 36 |
Pharmacokinetics similar to adults Mild adverse effects (33.3%) |
Winter H et al. 80
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Esomeprazole 2.5 to 10 mg/day Four weeks |
Multicentric, randomized, double-blinded, placebo-controlled (treatment and withdrawal) |
1 to 11 months n = 98 |
There was no statistical difference in treatment interruption due to worsening of symptoms between esomeprazole and placebo |
Hassall et al.46
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Omeprazole 0.7 to 3.5 mg/kg/day 21 months |
Prospective, open, long-term to test maintenance dose. |
1 to 16 years with healed EE n= 32 (completed the study) |
Remission was achieved with continuous use of omeprazole in most patients. 60% required more than half of the dose required for healing |