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

Phase 4

Terminated

• Conditions: Gastroesophageal Reflux Disease; Non-erosive Reflux Disease
• Interventions: Drug: Pantoprazole

• Registration Number: NCT00449813
• Lead Sponsor: Takeda

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-02
• Study First Submitted QC: 2007-03-20
• Study First Posted: 2007-03-21
• Primary Completion: 2007-10
• Status Verified: 2008-05
• Study Completion: 2008-11
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1.	Pantoprazole	40 mg Pantoprazole

Primary Outcome Measures

Name	Time	Method
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	8 weeks

Secondary Outcome Measures

Name	Time	Method
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	8 weeks

Trial Locations

Locations (1)

Altana Pharma/Nycomed; 🇨🇭 Zürich, Switzerland