Gastroesophageal Reflux Disease Clinical Trial
Official title:
The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-induced Changes in GERD-related Symptoms
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 using the ReQuestâ„¢ questionnaire. The assessment is made in GERD-patients treated with a daily dose of 40 mg oral pantoprazole over an 8-week period.
Status | Terminated |
Enrollment | 40 |
Est. completion date | November 2008 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Altana Pharma/Nycomed | BT Oss | |
Netherlands | Altana Pharma/Nycomed | Den Helder | |
Netherlands | Altana Pharma/Nycomed | EH Geldrop | |
Switzerland | Altana Pharma/Nycomed | Basel | |
Switzerland | Altana Pharma/Nycomed | Basel | |
Switzerland | Altana Pharma/Nycomed | Biel/Bienne | |
Switzerland | Altana Pharma/Nycomed | Bülach | |
Switzerland | Altana Pharma/Nycomed | Locarno, TI. | |
Switzerland | Altana Pharma/Nycomed | Luzern | |
Switzerland | Altana Pharma/Nycomed | Luzern | |
Switzerland | Altana Pharma/Nycomed | Reinach BL | |
Switzerland | Altana Pharma/Nycomed | Sion | |
Switzerland | Altana Pharma/Nycomed | Thun | |
Switzerland | Altana Pharma/Nycomed | Winterthur | |
Switzerland | Altana Pharma/Nycomed | Zürich |
Lead Sponsor | Collaborator |
---|---|
Takeda |
Netherlands, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of misclassification on day 14 based on heartburn as assessed by the investigator compared to symptom assessment by the patient using the ReQuestâ„¢-gastrointestinal (GI) questionnaire | 8 weeks | No | |
Secondary | Rate of misclassification on day 14 based on acid regurgitation as assessed by the investigator compared to symptom assessment by the patient using the ReQuestâ„¢-GI questionnaire | 8 weeks | No |
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