Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00312806
First received: April 10, 2006
Last updated: May 4, 2012
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux Disease (GERD)
Drug: Pantoprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™ [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response to treatment with pantoprazole at week 4, as measured by the questionnaire ReQuest™ [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
  • Investigator assessment [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
  • Safety and efficacy [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2000
Study Start Date: May 2006
Study Completion Date: July 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pantoprazole
    Pantoprazole 40 mg o.d.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312806

  Show 186 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Principal Investigator: Hans-Joachim Ulmer, MD Medical practice, D-71640 Ludwigsburg, Germany
  More Information

No publications provided by Takeda

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00312806     History of Changes
Other Study ID Numbers: BY1023/M3-341
Study First Received: April 10, 2006
Last Updated: May 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Takeda:
Gastroesophageal Reflux Disease
GERD
Pantoprazole
ReQuestTM

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Pantoprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014