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The problem
Intervention: Vonoprazan 10 mg or 20 mg once daily for 14 days
Who it was tested with: 42 children and adolescents aged 6-17 years with symptomatic GERD.
The same group is measured before the intervention and again afterwards, with a baseline and an endline and sometimes a midline. Change is visible, but other causes cannot be ruled out.
"Forty‐two subjects were randomized to vonoprazan 10 or 20 mg once daily for 14 days. Subjects reported improvement in GERD symptoms, regardless of vonoprazan dosage." This is a randomized trial measuring drug exposure and symptom response, but lacks a true comparison group and uses only qualitative symptom assessment, placing it in the PRE_POST tier.
Short 14-day study duration, small sample size (42 subjects), no control or comparison group, and qualitative rather than quantitative symptom assessment limit the strength of evidence for efficacy and long-term safety.
Across countries and designs
1 study · 1 country