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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. |
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Register:
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EUCTR |
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Last refreshed on:
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1 May 2012 |
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Main ID: |
EUCTR2006-001474-24-IT |
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Date of registration:
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09/03/2007 |
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Prospective Registration:
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Yes |
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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 - ND
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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 - ND |
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Date of first enrolment:
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24/04/2007 |
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Target sample size:
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92 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001474-24 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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France
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Germany
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Italy
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Contacts
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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:
Age maximum:
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
MedDRA version: 9.1
Level: LLT
Classification code 10017885
Term: Gastrooesophageal reflux disease
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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
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
Current Sponsor code: WAY-140951
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Product Name: Pantoprazole Sodium Delayed-Release Granules plus Inactive Powder Blend
Pharmaceutical Form: Gastro-resistant granules
Current Sponsor code: WAY-140951
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
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Primary Outcome(s)
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Main Objective: 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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Secondary Objective:
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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 ID(s)
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2006-001474-24-DE
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3001B3-335-WW
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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