A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer
Status:
Recruiting
Trial end date:
2023-01-04
Target enrollment:
Participant gender:
Summary
This is an open label, parallel group, multi-centre, phase III study to assess the safety and
efficacy of D961H in maintenance therapy following initial healing therapy in Japanese
paediatric patients with reflux esophagitis, and to assess the safety and efficacy of D961H
in Japanese paediatric patients treated with long term non-steroidal anti-inflammatory drugs
or low-dose aspirin therapy who have a documented medical history of gastric ulcer or
duodenal ulcer diagnosis.
Doses of D961H in this study is set for the 2 groups (weight more than equal 10 kg to less
than 20 kg and weight more than equal 20 kg) in the maintenance therapy for healed reflux
esophagitis group and the prevention of gastric ulcer or duodenal ulcer recurrence by
non-steroidal anti-inflammatory drugs or low-dose aspirin therapy group, Primary endpoints
are evaluated at week 32. Further, this study is designed to evaluate the long term efficacy
and safety of D961H for a maximum of 52 weeks, in consideration of the medical needs for long
term proton pump inhibitor treatment. Patient can continue study treatment up to 52 weeks, if
they want