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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
History of Changes

March 4, 2008
December 2, 2010
December 2007
Not Provided
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).
Presence/absence of Reflux Esophagitis according to Los Angeles classification [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00633932 on ClinicalTrials.gov Archive Site
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).
Presence/absence of Reflux Esophagitis according to Los Angeles classification. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Reflux Esophagitis Phase III Study (Initial Treatment)
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

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 .
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Reflux Esophagitis
  • Drug: Esomeprazole
    20mg once daily
    Other Name: Nexium
  • Drug: Esomeprazole
    40 mg once daily
    Other Name: Nexium
  • Drug: Omeprazole
    20mg once daily
    Other Name: Prilosec
  • Experimental: 1
    Esomeprazole 20mg
    Intervention: Drug: Esomeprazole
  • Experimental: 2
    Esomeprazole 40mg
    Intervention: Drug: Esomeprazole
  • Active Comparator: 3
    Omeprazole 20mg
    Intervention: Drug: Omeprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
602
December 2008
Not Provided

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00633932
D961HC00002
No
Tore Lind / Medical Science Director, AstraZeneca
AstraZeneca
Not Provided
Study Director: Maotsugu Oyama, MD, PhD AstraZeneca
AstraZeneca
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP