Nexium Capsules LDA Specific Clinical Experience Investig... | NCT01729182

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2013Actual

Primary Completion Date

Mar 9, 2017Actual

Completion Date

Mar 9, 2017Actual

First Submitted Date

Nov 14, 2012

First Submission Date that Met QC Criteria

Nov 14, 2012

First Posted Date

Nov 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2019

Last Update Posted Date

Aug 7, 2019Actual

Description Module

Brief Summary

The purpose of this investigation is to collect following data in patients given Nexium capsule (Nexium) for long term in usual-post-marketing therapy to prevention of recurrence of gastric ulcer or duodenal ulcer with Low dose Aspirin (LDA).

Detailed Description

Nexium capsules Specific Clinical Experience Investigation for long-term use concerning prevention of recurrence of gastric ulcer or duodenal ulcer with Low dose Aspirin (LDA).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,363Actual

Label	Type	Description	Intervention Names
Nexium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events incidence	Number of Adverse Drug Reactions	Up to 2 years

Secondary Outcomes

Measure	Description	Time Frame
Non-recurrence rate of peptic ulcer		Up to 2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Exclusion Criteria:

Patients having gastric ulcer/duodenal ulcer when Nexium is started (Active phase (A1, A2) or healing phase (H1, H2) of Sakita-Miwa classification on endoscopy).
Patients who had been given Nexium for suppression of recurrence of gastric ulcer/duodenal ulcer.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The patients who are continuously given Low dose Aspirin (LDA) to suppress thrombus/embolism and who will be given Nexium for the first time to suppress recurrence of gastric ulcer and duodenal ulcer.

(Patients who have previous experience of Nexium given in the treatment for gastric ulcer or duodenal ulcer can be registered to this S-CEI.)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shigeru Yoshida, MD	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Aichi			Japan
Research Site

References Module

Citations

Not provided

Label	URL
AZ\_Synopsis\_D961PC00002	View source
K. Sakamoto, M. Nii, T. Tokimoto and Y. Takumi Efficacy and Safety of Esomeprazole (Nexium) for the Prevention of Recurrent Gastric or Duodenal Ulcers in Patients on Continuous LDA; PMS of Long-term Use Jpn Pharmacol Ther, 47(6), 893 - 910, 2019	View source

ID	Term
D013276	Stomach Ulcer
D004381	Duodenal Ulcer

ID	Term
D010437	Peptic Ulcer
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D013272	Stomach Diseases