Reflux EsophagitisNCT02477475

Nexium Capsules S-CEI for Justification of Esomeprazole in Acid Related Disease for Reflux Symptom Healing Based on Patient Clinical Outcomes

An observational study of Reflux Esophagitis, run by AstraZeneca at 47 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this investigation is to collect following data in patients given NEXIUM capsule (NEXIUM) in usual post-marketing use. Read more about this study

Who is it for?: Any age
Conditions the study is for: Reflux Esophagitis
Type of treatment: Pill or oral medicine
How many people: 1,595 participants
Where: 47 sitesJapan
Study dates: 7 Jul 2015to 20 Feb 2017
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Since the target patient population of the S-CEI is symptomatic RE patients, the patients fulfilling the inclusion criteria and not the exclusion criteria shown below will be enrolled as the subjects of this investigation.

Who may be able to join

Patients to be enrolled in this S-CEI must fulfill all the criteria below at the start of the treatment with NEXIUM.
Aged at least 20 years.
Patients who has a current or past history of clinically diagnosed RE
Patients whose answers in the baseline GerdQ include "2-3 days" or "4-7 days" in at least one of the questions Nos 1, 2, 5 and 6.
Patients to whom NEXIUM 20 mg once daily is to be administered for RE
Patients from whom written consent has been obtained.

Who cannot join

Patients must not enter the investigation if any of the following exclusion criteria are fulfilled at the start of the treatment with NEXIUM:
Patients whose ability to follow instructions are suspected to be low by physicians
Patients with a past history of hypersensitivity to the ingredients of NEXIUM.
Patients receiving atazanavir sulfate or rilpivirine hydrochloride
Patients who have received NEXIUM within the past eight weeks for treatment of RE

Trial locations and contacts

47 sites in 1 country.

City, postcode or hospital

47 sites in 1 country

Japan47 sites

Research Site
Aichi
Research Site
Akita
Research Site
Aomori
Research Site
Chiba
Research Site
Ehime
Research Site
Fukui
Research Site
Fukuoka
Research Site
Fukushima
Research Site
Gifu
Research Site
Gunma
Research Site
Hiroshima
Research Site
Hokkaido
Research Site
Hyōgo
Research Site
Ibaraki
Research Site
Ishikawa
Research Site
Kagawa
Research Site
Kagoshima
Research Site
Kanagawa
Research Site
Kochi
Research Site
Kumamoto
Research Site
Kyoto
Research Site
Mie
Research Site
Miyagi
Research Site
Miyazaki
Research Site
Nagano
Research Site
Nagasaki
Research Site
Nara
Research Site
Niigata
Research Site
Numakunai
Research Site
Ōita
Research Site
Okayama
Research Site
Okinawa
Research Site
Osaka
Research Site
Saga
Research Site
Saitama
Research Site
Shiga
Research Site
Shimane
Research Site
Shizuoka
Research Site
Tochigi
Research Site
Tokushima
Research Site
Tokyo
Research Site
Tottori
Research Site
Toyama
Research Site
Wakayama
Research Site
Yamagata
Research Site
Yamaguchi
Research Site
Yamanashi

Other trials in Japan

About this study

Official title: NEXIUM Capsule Specific Clinical Experience Investigation (S-CEI) to Investigate Treatment Response to NEXIUM in Patients With Reflux Esophagitis (RE) - Justification of Esomeprazole in Acid Related Disease for Reflux Symptom Healing Based on Patient Clinical Outcomes

The objective of this investigation is to collect following data in patients given NEXIUM capsule (NEXIUM) in usual post-marketing use.

Read the detailed description

Primary objective To investigate treatment response to NEXIUM in patients with reflux esophagitis (RE).

Secondary objectives

To investigate following items in patients with RE:

Patient satisfactory level of the treatment for RE
Health-related quality of life (HRQOL)
Severity and frequency of RE symptoms reported by physicians
Endoscopic healing rate
Development of ADRs

Conditions: Reflux Esophagitis
Keywords: reflux esophagitis, Nexium
Medical subject headings: Esophagitis, Peptic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02477475
Study group	Role	What they receive
NEXIUM		Oral dose 20mg/day

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment response to NEXIUM based on answers in GerdQ
The rate of patients whose answers in the GerdQ are "none" or "one day" in the questions Nos 1, 2, 5 and 6 at the end of the observation.
GerdQ is a questionnaire for assessment of symptoms.
Measured: at the time of Treatment Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jul 201520 Feb 2017

First posted22 Jun 2015 (estimated)
Study start7 Jul 2015
Primary completion20 Feb 2017
Study completion20 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Reflux EsophagitisStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,595 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02477475
Sponsor's protocol ID: D961HL00020
Status last verified: Jun 2017
First submitted: 18 Jun 2015
Last updated: 21 Jun 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Not yet recruitingPhase 4
PPI Dosing Per CYP2C19 Genotype
Gastroesophageal Reflux Disease With Esophagitis
Active, not recruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System Disorder, Dyspepsia
RecruitingObservational study
Preoperative Predictors of Symptom Improvement After Laparoscopic Fundoplication
Gastroesophageal Reflux Disease, Hiatal Hernia
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn

All Reflux Esophagitis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: NEXIUM Capsule Specific Clinical Experience Investigation (S-CEI) to Investigate Treatment Response to NEXIUM in Patients With Reflux Esophagitis (RE) - Justification of Esomeprazole in Acid Related Disease for Reflux Symptom Healing Based on Patient Clinical Outcomes
ClinicalTrials.gov ID: NCT02477475
Acronym / sponsor ID: D961HL00020
Conditions: Reflux Esophagitis
Keywords: reflux esophagitis, Nexium
Study type: Observational
Recruitment status: Completed
Enrolment: 1,595 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 7 Jul 2015 (actual)
Primary completion: 20 Feb 2017 (actual)
Study completion: 20 Feb 2017 (actual)
First posted: 22 Jun 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this investigation is to collect following data in patients given NEXIUM capsule (NEXIUM) in usual post-marketing use.

Detailed description

Primary objective To investigate treatment response to NEXIUM in patients with reflux esophagitis (RE).

Secondary objectives

To investigate following items in patients with RE:

Patient satisfactory level of the treatment for RE
Health-related quality of life (HRQOL)
Severity and frequency of RE symptoms reported by physicians
Endoscopic healing rate
Development of ADRs

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
NEXIUM	–	–Oral dose 20mg/day

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Since the target patient population of the S-CEI is symptomatic RE patients, the patients fulfilling the inclusion criteria and not the exclusion criteria shown below will be enrolled as the subjects of this investigation.

Key inclusion criteria (6 listed)

Patients to be enrolled in this S-CEI must fulfill all the criteria below at the start of the treatment with NEXIUM.

Key exclusion criteria (5 listed)

Patients must not enter the investigation if any of the following exclusion criteria are fulfilled at the start of the treatment with NEXIUM:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Treatment response to NEXIUM based on answers in GerdQ
Time frame: at the time of Treatment Week 8
The rate of patients whose answers in the GerdQ are "none" or "one day" in the questions Nos 1, 2, 5 and 6 at the end of the observation. GerdQ is a questionnaire for assessment of symptoms.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
AZ\_Synopsis\_D961HL00020\_STUDY\_REPORT\_SUMMARYLink provided by the sponsor.

Related trials for Reflux Esophagitis

Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Not yet recruitingPhase 4
PPI Dosing Per CYP2C19 Genotype
Gastroesophageal Reflux Disease With Esophagitis
Active, not recruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System Disorder, Dyspepsia
RecruitingObservational study
Preoperative Predictors of Symptom Improvement After Laparoscopic Fundoplication
Gastroesophageal Reflux Disease, Hiatal Hernia
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shigeru Yoshida, MD study director

AstraZeneca

47 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Reflux Esophagitis, run by AstraZeneca at 47 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment response to NEXIUM based on answers in GerdQ (time frame: at the time of Treatment Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02477475.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2017.