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

NCT ID: NCT00449813

Last Updated: 2012-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease Non-erosive Reflux Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1.

40 mg Pantoprazole

Group Type ACTIVE_COMPARATOR

Pantoprazole

Intervention Type DRUG

40 mg Pantoprazole

Interventions

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Pantoprazole

40 mg Pantoprazole

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Nycomed

Principal Investigators

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M. Oudkerk Pool, Prof.

Role: PRINCIPAL_INVESTIGATOR

Isala Klieniken, Zwolle, The Netherlands

Locations

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Altana Pharma/Nycomed

BT Oss, , Netherlands

Site Status

Altana Pharma/Nycomed

Den Helder, , Netherlands

Site Status

Altana Pharma/Nycomed

EH Geldrop, , Netherlands

Site Status

Altana Pharma/Nycomed

Basel, , Switzerland

Site Status

Altana Pharma/Nycomed

Basel, , Switzerland

Site Status

Altana Pharma/Nycomed

Biel/Bienne, , Switzerland

Site Status

Altana Pharma/Nycomed

Bülach, , Switzerland

Site Status

Altana Pharma/Nycomed

Locarno, TI., , Switzerland

Site Status

Altana Pharma/Nycomed

Lucerne, , Switzerland

Site Status

Altana Pharma/Nycomed

Lucerne, , Switzerland

Site Status

Altana Pharma/Nycomed

Reinach, , Switzerland

Site Status

Altana Pharma/Nycomed

Sion, , Switzerland

Site Status

Altana Pharma/Nycomed

Thun, , Switzerland

Site Status

Altana Pharma/Nycomed

Winterthur, , Switzerland

Site Status

Altana Pharma/Nycomed

Zurich, , Switzerland

Site Status

Countries

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Netherlands Switzerland

Other Identifiers

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BY1023/NL511

Identifier Type: -

Identifier Source: org_study_id

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