Recent Updates
Recently added Catalysts

Esomeprazole twice daily

Phase 3

Refractory Reflux Esophagitis | Small molecule | Gastrointestinal |AstraZeneca PLC|Last Updated: Aug 27, 2015

Target and mechanism

ModalitySmall molecule

Also known as Esomeprazole (D961H) twice daily

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment1,398

FDA Designations

No designations recorded

Clinical trial landscape

Esomeprazole twice daily · 1 trial · 1 indication

Phase 3 1
NCT01669811Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)Refractory Reflux Esophagitis
COMPLETED1,398 Analytics
PHASE3COMPLETED
Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)
Refractory Reflux Esophagitis
NCT016698111,398
Unlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Healing of RE Who Were Graded "O" at Week 8 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification
8 Weeks

Percentage of participants with healing of reflux esophagitis (RE) who were graded "O" (No RE) at Week 8 out of participants who were graded "A" (least severe) to "D" (most severe) at baseline according to Los Angeles classification

Secondary Endpoints

Percentage of Participants With Healing of RE Who Were Graded "O" at Week 4 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification
4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Heartburn at Week 4
4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Acid Regurgitation at Week 4
4 Weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
D961H 20mg twice dailyEXPERIMENTALDouble-blinded
D961H 20mg once dailyACTIVE_COMPARATORDouble-blinded

Interventions

NameTypeDescription
Esomeprazole (D961H) twice dailyDRUGOne capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and in the evening
Esomeprazole (D961H) once dailyDRUGOne capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and one corresponding placebo capsule in the evening
Unlock Study Design Details

Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites63

Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures. 2. Patients with RE classified into LA classification Grade A, B, C or D by Endoscopy despite of at least 8-week treatment using standard doses of PPIs. 3. Patients must fulfill at least one of the followin...

Countries:Japan
Unlock Eligibility Criteria