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

NCT01397084 | Completed Phase 4 Results

• 1 other identifier: D961HL00002
• Study Type: interventional
• Target: 107
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gastroesophageal Reflux Disease; GERD; Reflux Esophagitis

Keywords

esomeprazole 20mg; heartburn; rabeprazole 10mg; reflux esophagitis; Phase IV

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  Baseline and 8 weeks

Secondary Outcomes (3)

• 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).

  Baseline and 4 weeks

• 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).

  Baseline and 4 weeks.

• 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).

  Baseline and 8 weeks

Study Arms (1)

esomeprazole 20 mg

OTHER

esomeprazole 20 mg

Drug: esomeprazole 20 mg

Interventions

esomeprazole 20 mg DRUG

esomeprazole 20 mg once daily for 8 weeks

esomeprazole 20 mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

MeSH Terms

Conditions

Gastroesophageal Reflux; Esophagitis, Peptic; Heartburn

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophagitis; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: James Armbrust
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Masataka Date

  AZ K.K.

  STUDY DIRECTOR

• Makiko Abe

  AZ K.K

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 19, 2011
• Study Start: August 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 21, 2013
• Results First Posted: February 18, 2013

Record last verified: 2013-02