| April 10, 2006 |
| December 12, 2008 |
| 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.
|
| |
| 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. |
| |
| Phase III |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
| Gastroesophageal Reflux Disease (GERD) |
| Drug: Pantoprazole |
| |
| |
| |
| 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
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| 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 |
| Nycomed, Nycomed |
| BY1023/M3-341 |
| ALTANA Pharma |
|
| Principal Investigator: |
Hans-Joachim Ulmer, MD |
Medical practice, D-71640 Ludwigsburg, Germany |
|
|
| ALTANA Pharma |
| December 2008 |