Reflux Esophagitis Phase III Study (Initial Treatment)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00633932
First received: March 4, 2008
Last updated: December 2, 2010
Last verified: December 2010
  Purpose

This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux Esophagitis at Week 8 according to the Los Angeles classification .


Condition Intervention Phase
Reflux Esophagitis
Drug: Esomeprazole
Drug: Omeprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of Esomeprazole 20 mg and 40 mg Once Daily Oral Administration With Omeprazole 20 mg Once Daily Oral Administration in Patients With Reflux Esophagitis

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 8 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification". [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).


Secondary Outcome Measures:
  • Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 4 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).


Enrollment: 602
Study Start Date: December 2007
Study Completion Date: December 2008
Arms Assigned Interventions
Experimental: 1
Esomeprazole 20mg
Drug: Esomeprazole
20mg once daily
Other Name: Nexium
Experimental: 2
Esomeprazole 40mg
Drug: Esomeprazole
40 mg once daily
Other Name: Nexium
Active Comparator: 3
Omeprazole 20mg
Drug: Omeprazole
20mg once daily
Other Name: Prilosec

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 1 week before randomisation

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633932

Locations
Japan
Research Site
Kashiwa, Chiba, Japan
Research Site
Kisarazu, Chiba, Japan
Research Site
Koriyama, Fukishima, Japan
Research Site
Nihonmatsu, Fukishima, Japan
Research Site
Nishishirakawa, Fukishima, Japan
Research Site
Kurume, Fukuoka, Japan
Research Site
Nukaya, Fukuoka, Japan
Research Site
Shirakawa, Fukushima, Japan
Research Site
Sugawa, Fukushima, Japan
Research Site
Gifu-shi, Gifu, Japan
Research Site
Maebashi, Gunma, Japan
Research Site
Yasunaka, Gunma, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Hitachi, Ibaraki, Japan
Research Site
Mito, Ibaraki, Japan
Research Site
Tsukuba, Ibaraki, Japan
Research Site
Sakaide, Kagawa, Japan
Research Site
Takamatsu, Kagawa, Japan
Research Site
Fujisawa, Kanagawa, Japan
Research Site
Kawasaki, Kanagawa, Japan
Research Site
Sagamihara, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Shibata, Myagi, Japan
Research Site
Kiso, Nagano, Japan
Research Site
Matsumoto, Nagano, Japan
Research Site
Fujiidera, Osaka, Japan
Research Site
Toyonaka, Osaka, Japan
Research Site
Ohtawara, Tochigi, Japan
Research Site
Toshima-ku, Tokayo, Japan
Research Site
Adachi, Tokyo, Japan
Research Site
Hachioji, Tokyo, Japan
Research Site
Kiyose, Tokyo, Japan
Research Site
Setagaya, Tokyo, Japan
Research Site
Shinagawa, Tokyo, Japan
Research Site
Shimonoseki, Yamaguchi, Japan
Research Site
Akita, Japan
Research Site
Fukuoka, Japan
Research Site
Kyoto, Japan
Research Site
Oita, Japan
Research Site
Shizuoka, Japan
Research Site
Tottori, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Maotsugu Oyama, MD, PhD AstraZeneca
  More Information

No publications provided

Responsible Party: Tore Lind / Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00633932     History of Changes
Other Study ID Numbers: D961HC00002
Study First Received: March 4, 2008
Results First Received: December 10, 2009
Last Updated: December 2, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Reflux Esophagitis

Additional relevant MeSH terms:
Esophagitis
Esophagitis, Peptic
Gastroesophageal Reflux
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Esophageal Motility Disorders
Deglutition Disorders
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014