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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

April 10, 2006
May 4, 2012
May 2006
March 2007   (final data collection date for primary outcome measure)
Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™ [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™.
Complete list of historical versions of study NCT00312806 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Response to treatment with pantoprazole at week 4, as measured by the questionnaire ReQuest™
  • investigator assessment
  • safety and efficacy.
Not Provided
Not Provided
 
Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastroesophageal Reflux Disease (GERD)
Drug: Pantoprazole
Pantoprazole 40 mg o.d.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2000
July 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   France,   Germany,   Hong Kong,   India,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Poland,   Portugal,   Singapore,   South Africa,   Spain,   Switzerland,   Taiwan,   United Kingdom
 
NCT00312806
BY1023/M3-341
Not Provided
Nycomed
Takeda
Not Provided
Principal Investigator: Hans-Joachim Ulmer, MD Medical practice, D-71640 Ludwigsburg, Germany
Takeda
December 2008

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