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

Takeda

Status and phase

Terminated

Phase 4

Conditions

Non-erosive Reflux Disease

Gastroesophageal Reflux Disease

Treatments

Drug: Pantoprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00449813

BY1023/NL511

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No 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