The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-Induced Changes in GERD-Related Symptoms (BY1023/NL511)
Information source: ALTANA Pharma
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux Disease; Non-Erosive Reflux Disease
Intervention: Pantoprazole (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: ALTANA Pharma Official(s) and/or principal investigator(s):
M. Oudkerk Pool, Prof., Principal Investigator, Affiliation: Isala Klieniken, Zwolle, The Netherlands
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 using the ReQuest™ questionnaire. The assessment is made in GERD-patients treated
with a daily dose of 40 mg oral pantoprazole over an 8-week period.
Clinical Details
Official title: The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-Induced Changes in GERD-Related Symptoms
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: Rate of misclassification on day 14 based on heartburn as assessed by the investigator compared to symptom assessment by the patient using the ReQuest™-gastrointestinal (GI) questionnaire
Secondary outcome: Rate of misclassification on day 14 based on acid regurgitation as assessed by the investigator compared to symptom assessment by the patient using the ReQuest™-GI questionnaire
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Altana Pharma / Nycomed GmbH, Den Helder 5342, Netherlands
Altana Pharma / Nycomed GmbH, BT Oss 5342, Netherlands
Altana Pharma / Nycomed GmbH, Geldrop 5664, Netherlands
Altana Pharma / Nycomed GmbH, Basel 4001, Switzerland
Altana Pharma / Nycomed, Zürich 8050, Switzerland
Altana Pharma / Nycomed GmbH, Thun 3600, Switzerland
Altana Pharma / Nycomed GmbH, Locarno 6600, Switzerland
Altana Pharma / Nycomed GmbH, Sion 1950, Switzerland
Altana Pharma / Nycomed GmbH, Luzern 6003, Switzerland
Altana Pharma / Nycomed GmbH, Biel 2502, Switzerland
Altana Pharma / Nycomed GmbH, Winterthur 8400, Switzerland
Altana Pharma / Nycomed GmbH, Bülach 8180, Switzerland
Altana Pharma / Nycomed GmbH, Luzern 6004, Switzerland
Altana Pharma / Nycomed GmbH, Reinach 4153, Switzerland
Altana Pharma / Nycomed GmbH, Basel 4051, Switzerland
Additional Information
Starting date: March 2007
Ending date: November 2008
Last updated: May 15, 2008
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