Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-induced Gastric Ulcer

Gastric Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401752
• Other study ID #: D9617L00001
• Status: Completed
• Phase: Phase 3
• First received: November 17, 2006
• Last updated: June 10, 2010
• Start date: March 2006
• Est. completion date: November 2008

Study information

• Verified date: June 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Ulcer
• Stomach Ulcer
• Ulcer

Intervention

Drug:
• Esomeprazole

• Ranitidine

Locations

Country	Name	City	State
China	Research Site	Beijing
China	Research Site	Fuzhou	Fujian
China	Research Site	Guangzhou	Guangdong
China	Research Site	Shanghai
China	Research Site	Shenyang	Liaoning
China	Research Site	Suzhou	Jiangsu
China	Research Site	Wuhan	Hubei
China	Research Site	Xi'an	Shanxi
Hong Kong	Research Site	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	4 weeks	No
Secondary	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.	8 weeks	No
Secondary	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.	week 4 and week 8	No
Secondary	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.	8 weeks	Yes
Secondary	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.	4 and 8 week	No
Secondary	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.	4 & 8 weeks	No