The purpose of this study is to assess the efficacy of esomeprazole 20 mg dosed once daily and ranitidine 150 mg dosed twice daily through 4 weeks of treatment for the healing of gastric ulcers in patients receiving daily non-steroidal anti-inflammatory drug (NSAID)therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
397
Research Site
Fuzhou, Fujian, China
Research Site
Guangzhou, Guangdong, China
Research Site
Wuhan, Hubei, China
Research Site
Suzhou, Jiangsu, China
The Percentage of Subjects Whose Gastric Ulcer(s) (GUs) Was (Were) Healed at Week 4 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily Non-steroidal Anti-inflammatory Drug (NSAID)Therapy.
Healed was defined as the absence of gastric ulcers. It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 4 weeks treatment. (Ulcers were on S stage, stage 1 = Nonblanchable erythema of intact skin, stage 2 = Partial thickness skin loss involving epidermis, dermis, or both, stage 3 = Full thickness skin loss involving damage to or necrosis of subcutaneous tissue, stage 4 = Full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures or absent).
Time frame: 4 weeks
The Percentage of Subjects Whose Gastric Ulcer(s) Was (Were) Healed at Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.
Healed was defined as the absence of gastric ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 8 weeks treatment.
Time frame: 8 weeks
The Resolution of Heartburn Symptoms at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.
Resolution rate of investigator-assessed GI symptoms, including heartburn, acid regurgitation, nausea, abdominal fullness and sleep disorder. It was calculated as the percentage of subjects whose heartburn symptoms were resolved at Week 8.
Time frame: week 4 and week 8
Percentage of Participants With the Occurance of Any Adverse Event.
Safety evaluation including vital signs, physical examination, ECG, adverse events and clinical laboratory evaluations during 8 weeks treatment.
Time frame: 8 weeks
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Research Site
Shenyang, Liaoning, China
Research Site
Xi’an, Shanxi, China
Research Site
Beijing, China
Research Site
Shanghai, China
Research Site
Hong Kong, Hong Kong
The Percentage of Participants Whose Duodenal Ulcer(s) (DUs) Was (Were) Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.
Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose duodenal ulcer healed after 4 and 8 weeks treatment.
Time frame: 4 and 8 week
The Percentage of Participants Whose GU(s) and DU(s) in Combination Were Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy
Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric and duodenal ulcer healed after 4 and 8 weeks treatment.
Time frame: 4 & 8 weeks