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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001474-24-BE

Enrollment

Registered

2006-05-11

Start date

2006-08-07

Completion date

Unknown

Last updated

2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

INFANTS AGED LESS THAN 12 MONTHS WITH PRESUMED GERD

Interventions

Product Name: Pantoprazole Sodium Delayed-Release Granules Plus Inactive Powder Blend Pharmaceutical Form: Gastro-resistant granules INN or Proposed INN: Pantoprazole Sodium Sesquihydrate Current Spon

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the safety and tolerability of pantoprazole in infants aged less than 12 months with presumed GERD.;Secondary Objective: NA;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.	—

Measure

Time frame

Main Objective: To assess the safety and tolerability of pantoprazole in infants aged less than 12 months with presumed GERD.;Secondary Objective: NA;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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Countries

Belgium, France, Germany, Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026