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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00317044 |
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Date of registration:
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20/04/2006 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma
RELAX |
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Scientific title:
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A 6-Month Randomized, Double-Blind, Parallel-Group, Multicentre, Placebo-Controlled Phase II Study to Compare Anti-Asthmatic Effect and Safety of Esomeprazole (Nexium®) 40 mg Twice Daily or 40 mg Once Daily With Placebo in Adults With Asthma |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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1100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00317044 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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Argentina
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Bulgaria
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Canada
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Czech Republic
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France
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Germany
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Hungary
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Italy
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Mexico
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Poland
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Portugal
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Slovakia
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Switzerland
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United States
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Contacts
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Name:
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AstraZeneca Nexium Medical Science Director, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adults with diagnosis of asthma since at least 6 months.
- Symptoms of asthma during run-in.
- At least 3 months history and present symptoms of 1 or more of the following: burning
feeling behind breastbone, pain behind breastbone, acid taste in the mouth.
Exclusion Criteria:
- Patients with clinically relevant abnormalities.
- Patients with a smoking history of =10 pack-year.
- Patients who have had previous surgery on the esophagus or the stomach.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Asthma
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GERD
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Intervention(s)
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Drug: Esomeprazole
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Primary Outcome(s)
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Primary objective is to compare the anti-asthmatic effect of esomeprazole with that of placebo in adult asthmatics with gastroesophageal reflux by evaluating change in morning Peak Expiratory Flow from baseline (run-in) to treatment period.
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Secondary Outcome(s)
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Secondary objectives are to investigate the effect on symptoms of GERD as measured by Reflux Disease Questionnaire from randomization to end of study and to assess safety and tolerability by AEs, laboratory tests, physical examination, and vital signs.
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Secondary ID(s)
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D9618C00001
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RELAX
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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