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

This study has been completed.
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01397084
First received: July 18, 2011
Last updated: February 18, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux Disease
GERD
Reflux Esophagitis
Drug: esomeprazole 20 mg
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An 8-week, Open Label, Multicentre Study to Assess the Efficacy of Esomeprazole 20 mg Once Daily in Subjects With Continuing Symptoms of Heartburn Following Treatment With a Previous Rabeprazole

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1). [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: Yes ]
    The number of days with heartburn during the 7-day period prior to the 8 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 8 weeks was analysed.


Secondary Outcome Measures:
  • Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1). [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    The number of days with heartburn during the 7-day period prior to the 4 week visit (Visit 2) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 4 weeks was analysed.

  • Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). [ Time Frame: Baseline and 4 weeks. ] [ Designated as safety issue: No ]
    Maximum severity of heartburn during 7 days at baseline and at 4 weeks was obtained (None, Mild, Moderate, Severe). If the value at 4 weeks was better than at baseline in a participant, the participant was s categorized into "Improved". If the value was same, then categorised into "Unchanged". If the value was worsened, categorised into "Worsened".

  • Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    Maximum severity of heartburn during 7 days at baseline and at 8 weeks was obtained (None, Mild, Moderate, Severe). If the value at 8 weeks was better than at baseline in a participant, the participant was s categorized into "Improved". If the value was same, then categorised into "Unchanged". If the value was worsened, categorised into "Worsened".


Enrollment: 107
Study Start Date: August 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
esomeprazole 20 mg
esomeprazole 20 mg
Drug: esomeprazole 20 mg
esomeprazole 20 mg once daily for 8 weeks

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397084

Sponsors and Collaborators
AstraZeneca
Parexel
Investigators
Study Director: Masataka Date AZ K.K.
Study Chair: Makiko Abe AZ K.K
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01397084     History of Changes
Other Study ID Numbers: D961HL00002
Study First Received: July 18, 2011
Results First Received: January 16, 2013
Last Updated: February 18, 2013
Health Authority: Singapore: Health Sciences Authority
Philippines: Bureau of Food and Drugs

Keywords provided by AstraZeneca:
esomeprazole 20mg
heartburn
rabeprazole 10mg
reflux esophagitis
Phase IV

Additional relevant MeSH terms:
Esophagitis
Esophagitis, Peptic
Gastroesophageal Reflux
Heartburn
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastroenteritis
Gastrointestinal Diseases
Peptic Ulcer
Signs and Symptoms
Signs and Symptoms, Digestive
Esomeprazole
Rabeprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014