Trial Outcomes & Findings for Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy (NCT NCT01874535)
NCT ID: NCT01874535
Last Updated: 2018-09-04
Results Overview
Rate of complete symptom relief (CSR) at the end of initial treatment phase
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
408 participants
Primary outcome timeframe
at the 20 weeks after the end of initial treatment.
Results posted on
2018-09-04
Participant Flow
Participant milestones
| Measure |
4-week Group
Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily
Esomeprazole 40 mg: Comparison of 4-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis
|
8-week Group
Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily
Esomeprazole 40 mg: Comparison of 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis
|
|---|---|---|
|
Overall Study
STARTED
|
207
|
201
|
|
Overall Study
COMPLETED
|
152
|
157
|
|
Overall Study
NOT COMPLETED
|
55
|
44
|
Reasons for withdrawal
| Measure |
4-week Group
Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily
Esomeprazole 40 mg: Comparison of 4-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis
|
8-week Group
Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily
Esomeprazole 40 mg: Comparison of 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
9
|
|
Overall Study
incomplete symptom resolution
|
45
|
35
|
Baseline Characteristics
Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy
Baseline characteristics by cohort
| Measure |
4-week Group
n=207 Participants
Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily
Esomeprazole 40 mg: Comparison of 4-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis
|
8-week Group
n=201 Participants
Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily
Esomeprazole 40 mg: Comparison of 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis
|
Total
n=408 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
age
|
51.1 years
STANDARD_DEVIATION 12.8 • n=99 Participants
|
51.1 years
STANDARD_DEVIATION 12.8 • n=107 Participants
|
51.1 years
STANDARD_DEVIATION 12.8 • n=206 Participants
|
|
Sex: Female, Male
sex · Female
|
87 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
164 Participants
n=206 Participants
|
|
Sex: Female, Male
sex · Male
|
120 Participants
n=99 Participants
|
124 Participants
n=107 Participants
|
244 Participants
n=206 Participants
|
|
Region of Enrollment
Taiwan
|
207 Participants
n=99 Participants
|
201 Participants
n=107 Participants
|
408 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: at the 20 weeks after the end of initial treatment.Rate of complete symptom relief (CSR) at the end of initial treatment phase
Outcome measures
| Measure |
4 Week Group
n=207 Participants
Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily
Esomeprazole 40 mg: Comparison of 4-weeks weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis
|
8 Week Group
n=201 Participants
Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily
Esomeprazole 40 mg: Comparison of 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis
|
|---|---|---|
|
The Rates of Complete Symptom Relief
|
152 participants
|
157 participants
|
Adverse Events
4 Week Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
8 Week Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Seng-Kee Chuah and Dr. Wei-Chen Tai
Kaohsiung Chang Gung Memorial Hospital, Taiwan
Phone: 886-975056007
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place