The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-induced Changes in GERD-related Symptoms (BY1023/NL511)
Overview[ - collapse ][ - ]
| Purpose | The aim of the study is to compare two different endpoint measures: heartburn as assessed by the physicians versus gastroesophageal reflux disease (GERD)-related symptoms as assessed by the patient using the ReQuest™ questionnaire. The assessment is made in GERD-patients treated with a daily dose of 40 mg oral pantoprazole over an 8-week period. |
|---|---|
| Condition | Gastroesophageal Reflux Disease Non-erosive Reflux Disease |
| Intervention | Drug: Pantoprazole |
| Phase | Phase 4 |
| Sponsor | Takeda |
| Responsible Party | Takeda |
| ClinicalTrials.gov Identifier | NCT00449813 |
| First Received | March 2, 2007 |
| Last Updated | May 4, 2012 |
| Last verified | May 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 2, 2007 |
|---|---|
| Last Updated Date | May 4, 2012 |
| Start Date | March 2007 |
| Estimated Primary Completion Date | November 2008 |
| Current Primary Outcome Measures | Rate of misclassification on day 14 based on heartburn as assessed by the investigator compared to symptom assessment by the patient using the ReQuest™-gastrointestinal (GI) questionnaire [Time Frame: 8 weeks] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Rate of misclassification on day 14 based on acid regurgitation as assessed by the investigator compared to symptom assessment by the patient using the ReQuest™-GI questionnaire [Time Frame: 8 weeks] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-induced Changes in GERD-related Symptoms (BY1023/NL511) |
|---|---|
| Official Title | The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-induced Changes in GERD-related Symptoms |
| Brief Summary | The aim of the study is to compare two different endpoint measures: heartburn as assessed by the physicians versus gastroesophageal reflux disease (GERD)-related symptoms as assessed by the patient using the ReQuest™ questionnaire. The assessment is made in GERD-patients treated with a daily dose of 40 mg oral pantoprazole over an 8-week period. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
|
| Intervention | Drug: Pantoprazole 40 mg Pantoprazole |
| Study Arm (s) | Active Comparator: 1. 40 mg Pantoprazole |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | 40 |
| Estimated Completion Date | November 2008 |
| Estimated Primary Completion Date | October 2007 |
| Eligibility Criteria | Inclusion Criteria: - Written informed consent - Outpatients of at least 18 years of age - History of GERD-related symptoms of at least 6 months prior to baseline visit - Endoscopically-confirmed GERD or non-erosive GERD Exclusion Criteria: - Zollinger-Ellison syndrome or other gastric hypersecretory condition - Acute peptic ulcer and/or ulcer complications - Pyloric stenosis - Severe or unstable cardiovascular, pulmonary, and/or endocrine disease - Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of reliable contraception in women of child-bearing potential - Intake of any medication for the purpose of eradication of Helicobacter pylori (H. pylori) within the last 28 days prior to study start - Intake of systemic glucocorticoids or non-steroidal anti-inflammatory drugs including cyclooxygenase-2 (COX-2) inhibitors for more than 3 consecutive days within the last 28 days prior to study start; with the exception of acetylsalicylic acid not more than 150 mg per day |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Netherlands, Switzerland |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00449813 |
|---|---|
| Other Study ID Numbers | BY1023/NL511 |
| Has Data Monitoring Committee | No |
| Information Provided By | Takeda |
| Study Sponsor | Takeda |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: M. Oudkerk Pool, Prof. Isala Klieniken, Zwolle, The Netherlands |
| Verification Date | May 2008 |
Locations[ + expand ][ + ]
| Altana Pharma/Nycomed | BT Oss, Netherlands, 5342 |
|---|---|
| Altana Pharma/Nycomed | Den Helder, Netherlands, 1782 GZ |
| Altana Pharma/Nycomed | EH Geldrop, Netherlands, 5664 |
| Altana Pharma/Nycomed | Basel, Switzerland, 4051 |
| Altana Pharma/Nycomed | Basel, Switzerland, 4001 |
| Altana Pharma/Nycomed | Biel/Bienne, Switzerland, 2502 |
| Altana Pharma/Nycomed | Bülach, Switzerland, 8180 |
| Altana Pharma/Nycomed | Locarno, TI., Switzerland, 6600 |
| Altana Pharma/Nycomed | Luzern, Switzerland, 6003 |
| Altana Pharma/Nycomed | Luzern, Switzerland, 6004 |
| Altana Pharma/Nycomed | Reinach BL, Switzerland, 4153 |
| Altana Pharma/Nycomed | Sion, Switzerland, 1950 |
| Altana Pharma/Nycomed | Thun, Switzerland, 3600 |
| Altana Pharma/Nycomed | Winterthur, Switzerland, 8400 |
| Altana Pharma/Nycomed | Zürich, Switzerland, 8050 |