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The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-induced Changes in GERD-related Symptoms (BY1023/NL511)

This study has been terminated.
(Inclusion-rate does not seem feasible anymore to obtain te required number of patients before the end of the trial.)
Information provided by:
Takeda Identifier:
First received: March 2, 2007
Last updated: May 4, 2012
Last verified: May 2008
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.

Condition Intervention Phase
Gastroesophageal Reflux Disease
Non-erosive Reflux Disease
Drug: Pantoprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-induced Changes in GERD-related Symptoms

Resource links provided by NLM:

Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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 [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 8 weeks ]

Enrollment: 40
Study Start Date: March 2007
Study Completion Date: November 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1.
40 mg Pantoprazole
Drug: Pantoprazole
40 mg Pantoprazole


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00449813

Altana Pharma/Nycomed
BT Oss, Netherlands, 5342
Altana Pharma/Nycomed
Den Helder, Netherlands, 1782 GZ
Altana Pharma/Nycomed
EH Geldrop, Netherlands, 5664
Altana Pharma/Nycomed
Basel, Switzerland, 4001
Altana Pharma/Nycomed
Basel, Switzerland, 4051
Altana Pharma/Nycomed
Biel/Bienne, Switzerland, 2502
Altana Pharma/Nycomed
Bülach, Switzerland, 8180
Altana Pharma/Nycomed
Locarno, TI., Switzerland, 6600
Altana Pharma/Nycomed
Luzern, Switzerland, 6003
Altana Pharma/Nycomed
Luzern, Switzerland, 6004
Altana Pharma/Nycomed
Reinach BL, Switzerland, 4153
Altana Pharma/Nycomed
Sion, Switzerland, 1950
Altana Pharma/Nycomed
Thun, Switzerland, 3600
Altana Pharma/Nycomed
Winterthur, Switzerland, 8400
Altana Pharma/Nycomed
Zürich, Switzerland, 8050
Sponsors and Collaborators
Principal Investigator: M. Oudkerk Pool, Prof. Isala Klieniken, Zwolle, The Netherlands
  More Information

Responsible Party: Nycomed Identifier: NCT00449813     History of Changes
Other Study ID Numbers: BY1023/NL511
Study First Received: March 2, 2007
Last Updated: May 4, 2012

Keywords provided by Takeda:
Gastroesophageal reflux disease (GERD)
Non erosive reflux disease (NERD)

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2017