Efficacy of Esomeprazole in Patients With Frequent Heartburn (NEXT2)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Heartburn

Treatments: Drug: Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01370538

D961RC00002

Details and patient eligibility

About

This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn

Enrollment: 341 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and non-pregnant ,non-lactating females 18 years or older
• Experience heartburn at least 2 days a week
• Having heartburn that has responded to heartburn medication
• Must discontinue any current heartburn medications

Exclusion criteria

• Having a history of erosive esophagitis verified by endoscopy
• Having a history of GERD which was diagnosed by a physician
• Inability to take study medication or complete the study and all study procedures
• Subjects that have required more than one 14-day course of PPI treatment within the past 4 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

341 participants in 2 patient groups, including a placebo group

Esomeprazole 20 mg

Experimental group

Treatment:

Drug: Esomeprazole

Placebo

Placebo Comparator group

Treatment:

Drug: Esomeprazole