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. )

First Received on March 2, 2007. Last Updated on July 16, 2008 History of Changes

Sponsor:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00449813

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 IV

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:

MedlinePlus related topics: GERD Heartburn

Drug Information available for: Pantoprazole Pantoprazole Sodium

U.S. FDA Resources

Further study details as provided by ALTANA Pharma:

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
Estimated 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

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

ALTANA Pharma

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:	July 16, 2008
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by ALTANA Pharma:

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 February 09, 2012