Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)
Information source: ALTANA Pharma
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux Disease; GERD
Intervention: Pantoprazole (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: ALTANA Pharma Official(s) and/or principal investigator(s):
Hans-Joachim Ulmer, MD, Principal Investigator, Affiliation: Medical practice, D-71640 Ludwigsburg, Germany
Summary
The aim of the present study is to identify factors (such as symptom patterns and symptom
scores) that influence the response to treatment with pantoprazole using different evaluation
methods (e. g. ReQuest™ questionnaire, patient and investigator assessment). Pantoprazole will
be administered once daily in the morning at one dose level. The study duration consists of a
treatment period of 8 weeks. The study will provide further data on safety and tolerability
of pantoprazole.
Clinical Details
Official title: Real Life: Treatment Response in Patients With Symptoms Due to Gastroesophageal Reflux Disease Either With or Without Esophagitis Treated With Pantoprazole Sodium 40 mg o.d. Over 8 Weeks
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™.
Secondary outcome: Response to treatment with pantoprazole at week 4, as measured by the questionnaire ReQuestâ¢investigator assessment safety and efficacy.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Main Inclusion Criteria:
- Written informed consent
- Outpatients of at least 18 years (21 years in Argentina)
- Patient considered to have GERD symptoms
Main Exclusion Criteria:
- Acute peptic ulcer and/or ulcer complications
- Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including
COX-2-inhibitors (> 5 days on demand but not more than 3 consecutive days) during the
last 28 days before study start (except regular intake of acetylsalicylic acid at a
dose up to 163 mg/day)
- Intake of proton pump inhibitors during the last 10 days before study start
- Female patients of childbearing potential not using adequate means of birth control
- Pregnant or breast-feeding females
Locations and Contacts
ALTANA Pharma, Cities in Argentina, Argentina
ALTANA Pharma, Cities in Australia, Australia
ALTANA Pharma, Cities in Austria, Austria
ALTANA Pharma, Cities in Belgium, Belgium
ALTANA Pharma, Cities in Brazil, Brazil
ALTANA Pharma, Cities in Canada, Canada
ALTANA Pharma, Cities in France, France
Altana Pharma, Cities in Germany, Germany
ALTANA Pharma, Cities in Hong Kong, Hong Kong
ALTANA Pharma, Cities in India, India
ALTANA Pharma, Cities in Italy, Italy
Altana Pharma, Cities in South Korea, Korea, Republic of
ALTANA Pharma, Cities in Malaysia, Malaysia
Altana Pharma, Cities in Mexico, Mexico
ALTANA Pharma, Cities in Poland, Poland
Altana Pharma, Cities in Singapore, Singapore
Altana Pharma, South Africa, South Africa
Altana Pharma, Cities in Spain, Spain
Altana Pharma, Cities in Switzerland, Switzerland
Altana Pharma, Cities in Taiwan, Taiwan
Altana Pharma, Cities in the UK, United Kingdom
Additional Information
Starting date: May 2006
Last updated: February 2, 2007
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