Skip to main content

Table 1 Study inclusion and exclusion criteria

From: A non-interventional, observational study of a fixed combination of pepsin and amino acid hydrochloride in patients with functional dyspepsia

Demographic inclusion criteria

 • Males and females

 • Age ≥ 18 years to ≤75 years of age

Clinical inclusion criteria

 • Acute or chronic functional dyspepsia verifed by medical history

 • ≥ 2 of the following gastrointestinal symptoms at moderate severityawithin prior 4 weeks:

   Bad breath, burping, nausea, heartburn, feeling of fullness, epigastric pain

 • Undergo evaluation according to the Rome III criteria for FD [13, 14]b

Exclusion criteria

 • Contraindications to study treatment (e.g., Known allergies to active ingredients or excipients)

 • Presence of alarm symptoms

 • Significant accompanying gastrointestinal or other disease

 • Pregnancy or nursing of infant(s)

 • Patients with changes to medication within prior 6 weeks

 • Previous intake of pepsin and amino acid hydrochloride

  1. aDefined as moderately severe and moderately troublesome on ≥5 days in the prior 2 weeks
  2. bThe study was conducted prior to introduction of the Rome IV criteria [4]