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.
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.
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shigeru Yoshida, MD, Study director, AstraZeneca
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
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.
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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?
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.