A Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI) (NEON)

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: Esomeprazole 40 mg; Procedure: Physical Exam; Procedure: pregnancy test, if applicable; Other: Quality of Life Questionnaires

Study type: Interventional

Funder types: Industry

Identifiers

NCT00734097

NEON

D9612L00116

Details and patient eligibility

About

The purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment.

Enrollment: 314 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor
• informed consent
• over 18 years of age

Exclusion criteria

• Current course of Proton Pump inhibitor treatment for more than 8 weeks prior to enrolment in the study
• More than 1 other course of PPI treatment in the previous 12 month
• previous use of esomeprazole
• presence of alarm symptoms

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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314 participants in 1 patient group

Nexium 40 mgs

Experimental group

Treatment:

Procedure: pregnancy test, if applicable

Other: Quality of Life Questionnaires

Procedure: Physical Exam

Drug: Esomeprazole 40 mg