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.)
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00449813
First received: March 2, 2007
Last updated: May 4, 2012
Last verified: May 2008
  Purpose

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449813

Locations
Netherlands
Altana Pharma/Nycomed
BT Oss, Netherlands, 5342
Altana Pharma/Nycomed
Den Helder, Netherlands, 1782 GZ
Altana Pharma/Nycomed
EH Geldrop, Netherlands, 5664
Switzerland
Altana Pharma/Nycomed
Basel, Switzerland, 4051
Altana Pharma/Nycomed
Basel, Switzerland, 4001
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
Takeda
Investigators
Principal Investigator: M. Oudkerk Pool, Prof. Isala Klieniken, Zwolle, The Netherlands
  More Information

No publications provided

Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00449813     History of Changes
Other Study ID Numbers: BY1023/NL511
Study First Received: March 2, 2007
Last Updated: May 4, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Pantoprazole
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014