Reflux Esophagitis Clinical Trial
Official title:
A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of Esomeprazole 20 mg Once Daily Oral Administration With Omeprazole 10 mg and Esomeprazole 10 mg Once Daily Oral Administration in Maintenance Treatment in Patients With Healed Reflux Esophagitis
Verified date | May 2010 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Pharmaceuticals and Medical Devices Agency |
Study type | Interventional |
The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the treatment period (from the randomisation to the treatment completion) according to the Los Angeles classification.
Status | Completed |
Enrollment | 540 |
Est. completion date | May 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Patients with healed Reflux Esophagitis verified by EGD in the preceding study (D961HC00002) - Patients with endoscopically verified healed Reflux Esophagitis by EGD receiving general treatment with PPI Exclusion Criteria: - Gastric or duodenal ulcer verified by EGD within 12 weeks before randomisation. - Use of any PPI from 14 days before EGD performed at the screening visit to the day of randomisation. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Research Site | Adachi | Tokyo |
Japan | Research Site | Akita | |
Japan | Research Site | Fujiidera | Osaka |
Japan | Research Site | Fujisawa | Kanagawa |
Japan | Research Site | Fukuoika | Fukuoka |
Japan | Research Site | Fukuoka | Fukuolka |
Japan | Research Site | Fukuoka | |
Japan | Research Site | Gifu-shi | Gifu |
Japan | Research Site | Hachioji | Tokyo |
Japan | Research Site | Hitachi | Ibaraki |
Japan | Research Site | Kashiwa | Chiba |
Japan | Research Site | Kawasaki | Kanagawa |
Japan | Research Site | Kisarazu | Chiba |
Japan | Research Site | Kiso | Nagano |
Japan | Research Site | Kiyose | Tokyo |
Japan | Research Site | Koriyama | Fukishima |
Japan | Research Site | Koriyama | Fukushima |
Japan | Research Site | Kurume | Fukuoka |
Japan | Research Site | Kyoto | |
Japan | Research Site | Maebashi | Gunma |
Japan | Research Site | Matsumoto | Nagano |
Japan | Research Site | Mito | Ibaraki |
Japan | Research Site | Nihonmatsu | Fukishima |
Japan | Research Site | Nishishirakawa | Fukishima |
Japan | Research Site | Nukaya | Fukuoka |
Japan | Research Site | Ohtawara | Tochigi |
Japan | Research Site | Oita | |
Japan | Research Site | Sagamihara | Kanagawa |
Japan | Research Site | Sakaide | Kagawa |
Japan | Research Site | Sapporo | Hokkaido |
Japan | Research Site | Setagaya | Tokyo |
Japan | Research Site | Shibata | Myagi |
Japan | Research Site | Shimonoseki | Yamaguchi |
Japan | Research Site | Shinagawa | Tokyo |
Japan | Research Site | Shirakawa | Fukushima |
Japan | Research Site | Shizuoka | |
Japan | Research Site | Sugawa | Fukushima |
Japan | Research Site | Takamatsu | Kagawa |
Japan | Research Site | Toshima-ku | Tokayo |
Japan | Research Site | Tottori | |
Japan | Research Site | Toyonaka | Osaka |
Japan | Research Site | Tsukuba | Ibaraki |
Japan | Research Site | Yasunaka | Gunma |
Japan | Research Site | Yokohama | Kanagawa |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period. | Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated. | Up to 24 weeks | No |
Secondary | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment | Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 4 weeks after treatment was evaluated. | up to 4 weeks | No |
Secondary | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment | Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated. | Up to 12 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06170060 -
Treatment of Reflux With Sleeve Gastrectomy
|
N/A | |
Not yet recruiting |
NCT06062225 -
Protocol for Comparing the Efficacy of Three Reconstruction Methods of the Digestive Tract After Proximal Gastrectomy
|
N/A | |
Completed |
NCT01964131 -
BE Study Between a Capsule and a Sachet Formulation of D961H by Pharmacodynamics in Japanese Healthy Male Subjects
|
Phase 1 | |
Not yet recruiting |
NCT06056973 -
Jinghua Weikang Capsule in the Treatment of Reflux Esophagitis
|
Phase 4 | |
Completed |
NCT01008696 -
An Efficacy Study to Compare the Treatment Effects of Rabeprazole and Lansoprazole Depending on the Genotyping of CYP2C19 in Treating Reflux Esophagitis
|
Phase 4 | |
Recruiting |
NCT05899491 -
Role of ARMA in Selective Subset of Refractory GERD Patients.
|
N/A | |
Recruiting |
NCT01311908 -
Incidence of Reflux Esophagitis After Pancreaticoduodenectomy
|
N/A | |
Completed |
NCT03214081 -
Special Drug Use Surveillance of Vonoprazan for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"
|
||
Not yet recruiting |
NCT01560598 -
Adipokines and the Risk of Reflux Esophagitis
|
N/A | |
Completed |
NCT00859287 -
Omepral® Tablets Special Clinical Experience Investigation in Patients With Erosive Esophagitis
|
N/A | |
Completed |
NCT00206180 -
NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis
|
Phase 4 | |
Recruiting |
NCT04657848 -
Preliminary Efficacy Analysis of Cheng's Giraffe Reconstruction After Proximal Gastrectomy
|
N/A | |
Completed |
NCT02477475 -
Nexium Capsules S-CEI for Justification of Esomeprazole in Acid Related Disease for Reflux Symptom Healing Based on Patient Clinical Outcomes
|
N/A | |
Completed |
NCT03553563 -
A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer
|
Phase 3 | |
Completed |
NCT01381991 -
The Efficacy of i-Scan for Detecting Reflux Esophagitis
|
N/A | |
Completed |
NCT04673643 -
Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Reflux Esophagitis
|
N/A | |
Recruiting |
NCT04531475 -
Study to Evaluate the Safety and Efficacy of X842 in Patients With Reflux Esophagitis
|
Phase 2 | |
Completed |
NCT00586963 -
Proton Pump Inhibitor (PPI) Therapy for Newly Diagnosed Esophagitis
|
N/A | |
Completed |
NCT03388047 -
Feasibility of Multi-Spectral Endoscopic Imaging for Detection of Early Neoplasia in Barrett's Oesophagus
|
N/A | |
Recruiting |
NCT00154570 -
24 Hour Esophageal and Electrogastrography to Investigate the Mechanism of Reflux Esophagitis
|
N/A |