Clinical Trials Logo

Clinical Trial 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


Clinical Trial Description

Subjects are allocated to four groups based on their disease and weight. Number of Subjects Maintenance therapy for healed reflux esophagitis study part: - Group1:aged 1 to 14 years (weight more than equal 10 kg to less than 20 kg ), Maintenance phase, n=5 to 10 - Group2:aged 1 to 14 years (weight more than equal 20 kg), Maintenance phase, n=10 to 20 Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: - Group3:aged 1 to 14 years (weight more than equal 10 kg to less than 20 kg), n=5 to 10 at Week 0 - Group4:aged 1 to 14 years (weight more than equal 20 kg), n=10 to 20 at Week 0 All subjects have a D961H administration for 32 or 52 weeks. all esophagogastroduodenoscopy findings are reviewed by central evaluation committee and study is conducted based on the judgement of central evaluation committee. Data are entered in electric data capture system at study site by site staffs and all data are verified with source data by site monitors during the study. Analyses will be performed by AstraZeneca or its representatives. A comprehensive statistical analysis plan will be developed and finalised before database lock and will describe the subject populations to be included in the analyses, and procedures for accounting for missing, unused, and spurious data. This section is a summary of the planned statistical analyses of the primary and secondary endpoints. Any deviations from this plan will be reported in the clinical study report. Efficacy analyses are intended for Efficacy Analysis Set. ・Efficacy Analysis Set:All subjects who take at least 1 dose of the investigational product and have at least 1 efficacy datum assessment during the maintenance/prevention therapy period, and who have no important protocol deviation. All safety analyses are performed on the Safety Analysis Set. ・Safety Analysis Set:All subjects who take at least 1 dose of the investigational product and have any post-treatment assessment. Frequency and incidence rate of adverse events (AEs), serious adverse events (SAEs), discontinuation of investigational product due to adverse events (DAEs) and other significant adverse events (OAEs) will be presented by MedDRA System Organ Class (SOC) and Preferred Term (PT) for each group. In addition, summaries of AEs will be further broken down by maximum intensity and relationship to the investigational product as assigned by investigators ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03553563
Study type Interventional
Source AstraZeneca
Contact
Status Completed
Phase Phase 3
Start date July 24, 2018
Completion date December 27, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05518929 - Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients Phase 4
Completed NCT03291418 - To Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects Phase 1/Phase 2
Not yet recruiting NCT05526339 - HFNO Combined With NPA Reduces Hypoxia During Sedated Gastrointestinal Endoscopy In Obese Patients N/A
Completed NCT01435525 - Nexium Capsules Helicobacter Pylori Specific Clinical Experience Investigation N/A
Completed NCT01129011 - Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen Phase 3
Completed NCT00527787 - Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen Phase 3
Terminated NCT00594854 - Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec Phase 3
Recruiting NCT05517408 - Dose Exploration of Ciprofol for Sedation in Gastrointestinal Endoscopic Diagnosis and Treatment of Obese Patients. N/A
Recruiting NCT01946633 - Remote-controlled Capsule Endoscopy: a Feasibility Study N/A
Completed NCT01964131 - BE Study Between a Capsule and a Sachet Formulation of D961H by Pharmacodynamics in Japanese Healthy Male Subjects Phase 1
Completed NCT01150162 - Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation Phase 3
Recruiting NCT01037491 - Comparison of Ulcer Healing in Patients Taking Rabeprazole With Different Antiplatelets N/A
Completed NCT00960869 - Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers Phase 3
Completed NCT00961350 - A Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers Phase 3
Completed NCT00595517 - Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer Phase 3
Completed NCT00428701 - An Open-label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium Phase 4
Completed NCT01452711 - Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Gastric Ulcer Phase 3
Terminated NCT05579444 - Systems Biology of Gastrointestinal and Related Diseases
Completed NCT02761512 - Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Gastric Ulcer Phase 3
Recruiting NCT03057171 - A Study on the Gastrointestinal Disease and Helicobacter Pylori Controlled Long Non-coding RNA