NCT00595517

Brief Summary

The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
395

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

3 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

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
3 years until next milestone

Results Posted

Study results publicly available

September 14, 2012

Completed
Last Updated

September 14, 2012

Status Verified

August 1, 2012

Enrollment Period

1.9 years

First QC Date

January 7, 2008

Results QC Date

August 4, 2010

Last Update Submit

August 20, 2012

Conditions

Gastric UlcerDuodenal UlcerRheumatoid ArthritisOsteoarthritisLumbago

Keywords

gastrointestinalGINSAIDJapanJapaneseGastric ulcerduodenal ulcer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period

    up to 52 weeks

Secondary Outcomes (3)

  • Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment

    up to 4 weeks after treatment

  • Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment

    up to 12 weeks after treatment

  • Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment

    up to 24 weeks after treatment

Study Arms (1)

Esomeprazole 20 mg

EXPERIMENTAL

Esomeprazole 20 mg once daily

Drug: Esomeprazole 20 mg

Interventions

Esomeprazole 20 mgDRUG

Esomeprazole 20 mg once daily

Esomeprazole 20 mg

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical history of gastric and/or duodenal ulcer
  • A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age

You may not qualify if:

  • Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification
  • History of esophageal, gastric or duodenal surgery
  • Having severe liver disease or chronic renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Ōita, Japan

Location

Research Site

Saitama, Japan

Location

Research Site

Tokyo, Japan

Location

Related Publications (1)

  • Sugano K, Kinoshita Y, Miwa H, Takeuchi T; Esomeprazole NSAID Preventive Study Group. Safety and efficacy of long-term esomeprazole 20 mg in Japanese patients with a history of peptic ulcer receiving daily non-steroidal anti-inflammatory drugs. BMC Gastroenterol. 2013 Mar 26;13:54. doi: 10.1186/1471-230X-13-54.

    PMID: 23530709DERIVED

MeSH Terms

Conditions

Stomach UlcerDuodenal UlcerArthritis, RheumatoidOsteoarthritisLow Back Pain

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Peptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Naotsugu Oyama

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2008

First Posted

January 16, 2008

Study Start

October 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

September 14, 2012

Results First Posted

September 14, 2012

Record last verified: 2012-08

Locations

JP(3)