Clinical trial NCT00449813: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
Non-erosive Reflux Disease
Keywords: Gastroesophageal reflux disease (GERD)
Non erosive reflux disease (NERD)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2007-03-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: 8 weeks
Secondary outcomes:
measure: 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
timeFrame: 8 weeks
Other outcomes:
Locations:
city: BT Oss
country: Netherlands
facility: Altana Pharma/Nycomed
city: Den Helder
country: Netherlands
facility: Altana Pharma/Nycomed
city: EH Geldrop
country: Netherlands
facility: Altana Pharma/Nycomed
city: Basel
country: Switzerland
facility: Altana Pharma/Nycomed
city: Basel
country: Switzerland
facility: Altana Pharma/Nycomed
city: Biel/Bienne
country: Switzerland
facility: Altana Pharma/Nycomed
city: Bülach
country: Switzerland
facility: Altana Pharma/Nycomed
city: Locarno, TI.
country: Switzerland
facility: Altana Pharma/Nycomed
city: Luzern
country: Switzerland
facility: Altana Pharma/Nycomed
city: Luzern
country: Switzerland
facility: Altana Pharma/Nycomed
city: Reinach BL
country: Switzerland
facility: Altana Pharma/Nycomed
city: Sion
country: Switzerland
facility: Altana Pharma/Nycomed
city: Thun
country: Switzerland
facility: Altana Pharma/Nycomed
city: Winterthur
country: Switzerland
facility: Altana Pharma/Nycomed
city: Zürich
country: Switzerland
facility: Altana Pharma/Nycomed
Study officials:
affiliation: Isala Klieniken, Zwolle, The Netherlands
name: M. Oudkerk Pool, Prof.
role: PRINCIPAL_INVESTIGATOR
References: