To Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole

NCT01249651 | Completed Phase 4 Results

• 1 other identifier: D961HL00001
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Administration of esomeprazole 40 mg to subjects who still had heartburn after receiving rabeprazole 20 mg once daily for 4 to 8 weeks will result in statistically significant improvement of heartburn after 8-week treatment.

Conditions

Heartburn

Keywords

Patients, Single

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 to 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 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 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)

  Baseline to 8 weeks

Study Arms (1)

1

OTHER

One arm: esomeprazole 40 mg

Drug: esomeprazole 40 mg

Interventions

esomeprazole 40 mg DRUG

esomeprazole 40 mg once daily, 8 weeks

Also known as: No comparator

1

Eligibility Criteria

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

You may qualify if:

• Male or female aged 20 years or more
• Documented history of reflux esophagitis verified by endoscopy in the past, including the grade of Los Angeles (LA) classification (Lundell LR et al 1999) before treatment
• Ongoing (until date of Visit 1) treatment with rabeprazole 20 mg, given once daily, for a period of 4 to 8 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 during the past 7 days prior to Visit 1, judged by the investigator(s) as follows: At least 2 days with moderate (i.e. discomfort sufficient to cause interference with normal activities) to severe symptoms (i.e. incapacitating, with inability to perform normal activities) OR At least 4 days with symptoms including mild ones (i.e. awareness of sign or symptom, but easily tolerated).
• The subject needs to be able to understand and read the official languages of the country.

You may not qualify if:

• Use of other PPIs and/or H2RA during rabeprazole treatment
• Previous use of esomeprazole 40 mg during the 12 weeks before enrolment
• Current or historical evidence of gastrointestinal pathology
• History, signs or symptoms of clinically significant or uncontrolled cardiovascular, pulmonary, renal, endocrine, hematologic, neurologic, psychiatric pancreatic or hepatic disease as judged by the investigator to interfere with the conduct of the study, the interpretation of study results, subject compliance, or the health of the subject during the study.

Sponsors & Collaborators

• AstraZeneca: lead
• Quintiles, Inc.: collaborator

Study Sites (1)

Research Site

Beijing, China

Location

MeSH Terms

Conditions

Heartburn

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

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: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Masataka Date, MD, PhD

  AstraZeneca KK Corporate Communications

  STUDY DIRECTOR

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: November 26, 2010
• First Posted: November 30, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 31, 2012
• Results First Posted: October 31, 2012

Record last verified: 2012-06

Locations

CN (1)