To Assess the Efficacy of Esomeprazole 20mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 4

Conditions

Reflux Esophagitis
Gastroesophageal Reflux Disease
GERD

Treatments

Drug: esomeprazole 20 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01397084
D961HL00002

Details and patient eligibility

About

Administration of esomeprazole 20 mg to subjects who still had heartburn after receiving rabeprazole 10 mg once daily for at least 4 weeks will result in statistically significant improvement of heartburn after 8-week treatment.

Enrollment

107 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male of female aged 20 years or more
  • History of reflux esophagitis
  • Ongoing (until date of Visit 1) treatment with rabeprazole 10 mg, given once daily, for at least 4 weeks.The subject must take rabeprazole at least 4 days a week in the past 7 days prior to Visit 1.
  • Persisting symptoms of heartburn experienced at least 2 days during the past 7 days prior to Visit 1.

Exclusion criteria

  • Use of other PPIs and/or H2RA during rabeprazole treatment
  • History or having other gastrointestinal diseases
  • History of upper gastrointestinal surgery
  • Initiation of medications that can affect digestive functions within 4 weeks before study treatment
  • Inability to complete questionnaires

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

107 participants in 1 patient group

esomeprazole 20 mg
Other group
Description:
esomeprazole 20 mg
Treatment:
Drug: esomeprazole 20 mg

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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