Chest Pain Pilot Study
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|ClinicalTrials.gov Identifier: NCT00251901|
Recruitment Status : Completed
First Posted : November 11, 2005
Last Update Posted : January 24, 2011
|Condition or disease||Intervention/treatment||Phase|
|Chest Pain Gastroesophageal Reflux||Drug: Esomeprazole||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Double-Blind Placebo-Controlled Multi-Centre Pilot Study to Assess Symptom Response in Subjects With Pain or Discomfort in the Chest Receiving Oral Treatment With Esomeprazole 40 mg Bid for 4 Weeks.|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||July 2005|
|Actual Study Completion Date :||July 2005|
- Relief of pain or discomfort in the chest during the last week of the 4-week treatment course.
- Relief of pain or discomfort in the chest is defined as no more than one day with minimal symptoms according to the patients assessment
- Symptom response during the first week is based on diary cards, days 3-7.
- The investigator's overall assessment of pain or discomfort in the chest during the first and fourth week.
- Scores from the PRO instruments measuring pain, HRQL, anxiety and depression, health status, reflux related symptoms and overall treatment evaluation.
- Adverse events, clinical laboratory variables and vital signs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00251901
Show 79 Study Locations
|Study Director:||AstraZeneca Nexium Medical Sciences Director, MD||AstraZeneca|