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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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8 October 2021 |
Main ID: |
EUCTR2006-001474-24-FR |
Date of registration:
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23/07/2007 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A MULTICENTER, OPEN LABEL SAFETY STUDY OF 2 DOSES OF PANTOPRAZOLE SODIUM ENTERIC-COATED SPHEROID SUSPENSION IN INFANTS AGED LESS THAN 12 MONTHS WITH PRESUMED GERD
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Scientific title:
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A MULTICENTER, OPEN LABEL SAFETY STUDY OF 2 DOSES OF PANTOPRAZOLE SODIUM ENTERIC-COATED SPHEROID SUSPENSION IN INFANTS AGED LESS THAN 12 MONTHS WITH PRESUMED GERD |
Date of first enrolment:
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27/09/2007 |
Target sample size:
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92 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001474-24 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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France
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Germany
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Italy
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients must have participated in and successfully completed study 3001B3-333-WW or have completed study 3001B1-331-WW and are able to swallow 5 mL of test article and 5 mL rinse. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: 1) Failure to complete study 3001B3-333-WW or 3001B3-331-WW for any reason. 2) Clinically significant adverse events during study 3001B3-333-WW or 3001B3-331-WW, felt to be related (possibly or probably) to pantoprazole. 3) Any disorder requiring chronic (every day) use of warfarin, carbamazepine, or phenytoin. 4) Patient or PARENT felt to be unable to comply with study procedures in the investigator’s opinion 5) Use of special diets or herbal or alternative medication that might affect the metabolism of test article without prior approval of the Wyeth medical monitor. 6) More than 17 days beyond last dose of test article in 3001B3-333-WW or 3001B3-331-WW without medical monitor approval and repeat clinical laboratory tests, vital signs (including weight, length, head circumference) and physical examination.
Age minimum:
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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INFANTS AGED LESS THAN 12 MONTHS WITH PRESUMED GERD
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Intervention(s)
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Product Name: Pantoprazole Sodium Delayed-Release Granules Plus Inactive Powder Blend Pharmaceutical Form: Gastro-resistant granules INN or Proposed INN: Pantoprazole Sodium Sesquihydrate Current Sponsor code: WAY-140951 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5--
Product Name: Pantoprazole Sodium Delayed-Release Granules Plus Inactive Powder Blend Pharmaceutical Form: Gastro-resistant granules INN or Proposed INN: Pantoprazole Sodium Sesquihydrate Current Sponsor code: WAY-140951 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5--
Product Name: Pantoprazole Sodium Delayed-Release Granules Plus Inactive Powder Blend Pharmaceutical Form: Gastro-resistant granules INN or Proposed INN: Pantoprazole Sodium Sesquihydrate Current Sponsor code: WAY-140951 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10--
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Primary Outcome(s)
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Main Objective: To assess the safety and tolerability of pantoprazole in infants aged less than 12 months with presumed GERD.
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Primary end point(s): Safety will be evaluated from reported signs and symptoms, adverse events, scheduled physical examinations, vital signs, and clinical laboratory test results. These results will be summarized in tabular format. Growth parameters (weight, length, and head circumference) will be summarized.
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Secondary Objective: NA
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Secondary ID(s)
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2006-001474-24-BE
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3001B3–335-WW
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 27/09/2007
Contact:
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