NCT00401752

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
397

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2006

Typical duration for phase_3

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 8, 2010

Completed
Last Updated

July 8, 2010

Status Verified

June 1, 2010

First QC Date

November 17, 2006

Results QC Date

November 12, 2009

Last Update Submit

June 10, 2010

Conditions

Gastric Ulcer

Keywords

NSAID-associated gastric ulcer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • 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.

    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.

    week 4 and week 8

  • Percentage of Participants With the Occurance of Any Adverse Event.

    8 weeks

  • 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.

    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

    4 & 8 weeks

Interventions

EsomeprazoleDRUG
RanitidineDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Research Site

Fuzhou, Fujian, China

Location

Research Site

Guangzhou, Guangdong, China

Location

Research Site

Wuhan, Hubei, China

Location

Research Site

Suzhou, Jiangsu, China

Location

Research Site

Shenyang, Liaoning, China

Location

Research Site

Xi’an, Shanxi, China

Location

Research Site

Beijing, China

Location

Research Site

Shanghai, China

Location

Research Site

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Stomach Ulcer

Interventions

EsomeprazoleRanitidine

Condition Hierarchy (Ancestors)

Peptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingFurans

Limitations and Caveats

According to the protocol, the sample size was 320 patients which could achieve 80% power of superiority. Since the patient recruitment is very difficult, total 219 patients were randomized in present study, the power decreased to 60%

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Tore Lind, MD

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 17, 2006

First Posted

November 22, 2006

Study Start

March 1, 2006

Study Completion

November 1, 2008

Last Updated

July 8, 2010

Results First Posted

July 8, 2010

Record last verified: 2010-06

Locations

CN(8)HK(1)