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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02477475

Enrollment

1595

Registered

2015-06-22

Start date

2015-07-07

Completion date

2017-02-20

Last updated

2017-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reflux Esophagitis

Keywords

reflux esophagitis, Nexium

Brief summary

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: 1. Patient satisfactory level of the treatment for RE 2. Health-related quality of life (HRQOL) 3. Severity and frequency of RE symptoms reported by physicians 4. Endoscopic healing rate 5. Development of ADRs

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients to be enrolled in this S-CEI must fulfill all the criteria below at the start of the treatment with NEXIUM. 1. Aged at least 20 years. 2. Patients who has a current or past history of clinically diagnosed RE 3. 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. 4. Patients to whom NEXIUM 20 mg once daily is to be administered for RE 5. Patients from whom written consent has been obtained.

Exclusion criteria

* Patients must not enter the investigation if any of the following

Design outcomes

Primary

Measure	Time frame	Description
Treatment response to NEXIUM based on answers in GerdQ	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.

Countries

Japan

Outcome results