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

Primary Purpose

Gastroesophageal Reflux Disease, Non-erosive Reflux Disease

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Pantoprazole
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring Gastroesophageal reflux disease (GERD), Non erosive reflux disease (NERD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1.

Arm Description

40 mg Pantoprazole

Outcomes

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

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

Full Information

First Posted
March 2, 2007
Last Updated
May 4, 2012
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT00449813
Brief Title
The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-induced Changes in GERD-related Symptoms (BY1023/NL511)
Official Title
The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-induced Changes in GERD-related Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Terminated
Why Stopped
Inclusion-rate does not seem feasible anymore to obtain te required number of patients before the end of the trial.
Study Start Date
March 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Takeda

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Non-erosive Reflux Disease
Keywords
Gastroesophageal reflux disease (GERD), Non erosive reflux disease (NERD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.
Arm Type
Active Comparator
Arm Description
40 mg Pantoprazole
Intervention Type
Drug
Intervention Name(s)
Pantoprazole
Intervention Description
40 mg Pantoprazole
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Oudkerk Pool, Prof.
Organizational Affiliation
Isala Klieniken, Zwolle, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altana Pharma/Nycomed
City
BT Oss
ZIP/Postal Code
5342
Country
Netherlands
Facility Name
Altana Pharma/Nycomed
City
Den Helder
ZIP/Postal Code
1782 GZ
Country
Netherlands
Facility Name
Altana Pharma/Nycomed
City
EH Geldrop
ZIP/Postal Code
5664
Country
Netherlands
Facility Name
Altana Pharma/Nycomed
City
Basel
ZIP/Postal Code
4001
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Basel
ZIP/Postal Code
4051
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Biel/Bienne
ZIP/Postal Code
2502
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Bülach
ZIP/Postal Code
8180
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Locarno, TI.
ZIP/Postal Code
6600
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Luzern
ZIP/Postal Code
6003
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Luzern
ZIP/Postal Code
6004
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Reinach BL
ZIP/Postal Code
4153
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Sion
ZIP/Postal Code
1950
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Thun
ZIP/Postal Code
3600
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Winterthur
ZIP/Postal Code
8400
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Zürich
ZIP/Postal Code
8050
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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