To Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole
This study has been completed.
Sponsor:
AstraZeneca
Collaborator:
Quintiles East Asia Pte. Ltd.
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01249651
First received: November 26, 2010
Last updated: October 1, 2012
Last verified: June 2012
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| Tracking Information | |||||
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| First Received Date ICMJE | November 26, 2010 | ||||
| Last Updated Date | October 1, 2012 | ||||
| Start Date ICMJE | November 2010 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 to 8 weeks ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE |
Assess the efficacy of esomeprazole 40 mg [ Time Frame: During the 7-day period prior to the 8 week visit (Visit 3) ] [ Designated as safety issue: No ] To assess the efficacy of esomeprazole 40 mg once daily in subjects who still had heartburn after receiving rabeprazole 20 mg once daily for 4 to 8 weeks by evaluating the 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 Visit 1, after treatment with esomeprazole 40 mg. |
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| Change History | Complete list of historical versions of study NCT01249651 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | To Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole | ||||
| Official Title ICMJE | An 8-week, Open Label, Multicentre Study to Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects With Continuing Symptoms of Heartburn Following Treatment With a Previous Rabeprazole. | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Heartburn | ||||
| Intervention ICMJE | Drug: esomeprazole 40 mg
esomeprazole 40 mg once daily, 8 weeks
Other Name: No comparator |
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| Study Arm (s) | 1
One arm: esomeprazole 40 mg
Intervention: Drug: esomeprazole 40 mg |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 101 | ||||
| Completion Date | June 2011 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01249651 | ||||
| Other Study ID Numbers ICMJE | D961HL00001 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | AstraZeneca | ||||
| Study Sponsor ICMJE | AstraZeneca | ||||
| Collaborators ICMJE | Quintiles East Asia Pte. Ltd. | ||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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