Status:
TERMINATED
The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-induced Changes in GERD-related Symptoms (BY1023/NL511)
Lead Sponsor:
Takeda
Conditions:
Gastroesophageal Reflux Disease
Non-erosive Reflux Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of the study is to compare two different endpoint measures: heartburn as assessed by the physicians versus gastroesophageal reflux disease (GERD)-related symptoms as assessed by the patient us...
Eligibility Criteria
Inclusion
- Written informed consent
- Outpatients of at least 18 years of age
- History of GERD-related symptoms of at least 6 months prior to baseline visit
- Endoscopically-confirmed GERD or non-erosive GERD
Exclusion
- Zollinger-Ellison syndrome or other gastric hypersecretory condition
- Acute peptic ulcer and/or ulcer complications
- Pyloric stenosis
- Severe or unstable cardiovascular, pulmonary, and/or endocrine disease
- Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of reliable contraception in women of child-bearing potential
- Intake of any medication for the purpose of eradication of Helicobacter pylori (H. pylori) within the last 28 days prior to study start
- Intake of systemic glucocorticoids or non-steroidal anti-inflammatory drugs including cyclooxygenase-2 (COX-2) inhibitors for more than 3 consecutive days within the last 28 days prior to study start; with the exception of acetylsalicylic acid not more than 150 mg per day
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00449813
Start Date
March 1 2007
End Date
November 1 2008
Last Update
May 7 2012
Active Locations (15)
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1
Altana Pharma/Nycomed
BT Oss, Netherlands, 5342
2
Altana Pharma/Nycomed
Den Helder, Netherlands, 1782 GZ
3
Altana Pharma/Nycomed
EH Geldrop, Netherlands, 5664
4
Altana Pharma/Nycomed
Basel, Switzerland, 4001