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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-induced Changes in GERD-related Symptoms

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00449813
• Other study ID #: BY1023/NL511
• Status: Terminated
• Phase: Phase 4
• First received: March 2, 2007
• Last updated: May 4, 2012
• Start date: March 2007
• Est. completion date: November 2008

Study information

• Verified date: May 2008
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: November 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Non-erosive Reflux Disease

Intervention

Drug:
• Pantoprazole
40 mg Pantoprazole

Locations

Country	Name	City	State
Netherlands	Altana Pharma/Nycomed	BT Oss
Netherlands	Altana Pharma/Nycomed	Den Helder
Netherlands	Altana Pharma/Nycomed	EH Geldrop
Switzerland	Altana Pharma/Nycomed	Basel
Switzerland	Altana Pharma/Nycomed	Basel
Switzerland	Altana Pharma/Nycomed	Biel/Bienne
Switzerland	Altana Pharma/Nycomed	Bülach
Switzerland	Altana Pharma/Nycomed	Locarno, TI.
Switzerland	Altana Pharma/Nycomed	Luzern
Switzerland	Altana Pharma/Nycomed	Luzern
Switzerland	Altana Pharma/Nycomed	Reinach BL
Switzerland	Altana Pharma/Nycomed	Sion
Switzerland	Altana Pharma/Nycomed	Thun
Switzerland	Altana Pharma/Nycomed	Winterthur
Switzerland	Altana Pharma/Nycomed	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No