Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00312806
Recruitment Status : Completed
First Posted : April 11, 2006
Last Update Posted : May 7, 2012
Sponsor:
Information provided by:
Takeda

Tracking Information
First Submitted Date  ICMJE April 10, 2006
First Posted Date  ICMJE April 11, 2006
Last Update Posted Date May 7, 2012
Study Start Date  ICMJE May 2006
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2008)
Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™ [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2006)
Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2008)
  • Response to treatment with pantoprazole at week 4, as measured by the questionnaire ReQuest™ [ Time Frame: 4 and 8 weeks ]
  • Investigator assessment [ Time Frame: 4 and 8 weeks ]
  • Safety and efficacy [ Time Frame: 4 and 8 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2006)
  • Response to treatment with pantoprazole at week 4, as measured by the questionnaire ReQuest™
  • investigator assessment
  • safety and efficacy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastroesophageal Reflux Disease (GERD)
Intervention  ICMJE Drug: Pantoprazole
Pantoprazole 40 mg o.d.
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 10, 2006)
2000
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   France,   Germany,   Hong Kong,   India,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Poland,   Portugal,   Singapore,   South Africa,   Spain,   Taiwan,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00312806
Other Study ID Numbers  ICMJE BY1023/M3-341
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nycomed
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hans-Joachim Ulmer, MD Medical practice, D-71640 Ludwigsburg, Germany
PRS Account Takeda
Verification Date December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP