Clinical trial NCT00401752: Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-induced Gastric Ulcer
Official title: A Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, 8 Week Comparative Efficacy and Safety Study of Esomeprazole 20 mg Every Day (qd) Versus Ranitidine 150 mg Twice a Day (Bid) in Patients With an NSAID-associated Gastric Ulcer When Daily NSAID is Continued
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Ulcer
Keywords: NSAID-associated gastric ulcer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-11-22
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent.
* A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 2 months.
* Daily NSAID dose and type must have been stable for at least 2 weeks prior to the baseline endoscopy;orally;

Exclusion Criteria:

* History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer.
* History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.

Primary outcomes:
measure: 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.
timeFrame: 4 weeks
Secondary outcomes:
measure: 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.
timeFrame: 8 weeks
measure: 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.
timeFrame: week 4 and week 8
measure: Percentage of Participants With the Occurance of Any Adverse Event.
timeFrame: 8 weeks
measure: 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.
timeFrame: 4 and 8 week
measure: 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
timeFrame: 4 & 8 weeks
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Research Site
state: Fujian
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Suzhou
country: China
facility: Research Site
state: Jiangsu
city: Shenyang
country: China
facility: Research Site
state: Liaoning
city: Xi'an
country: China
facility: Research Site
state: Shanxi
city: Beijing
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Tore Lind, MD
role: STUDY_DIRECTOR
References: