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Study Evaluating Pantoprazole in Children With GERD

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Wyeth

Status and phase

Completed
Phase 3

Conditions

Gastroesophageal Reflux

Treatments

Drug: pantoprazole for approximately 9 weeks.

Study type

Interventional

Funder types

Industry

Identifiers

NCT00141817
B1791059
3001B3-334

Details and patient eligibility

About

The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD.

Enrollment

41 patients

Sex

All

Ages

1 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Endoscopically proven GERD diagnosed within 6 months before study entry.
  • Weight must be equal to or over 8.3 kg; for subjects 6 years or greater, weight must be equal to or under 25 kg

Exclusion criteria

  • History of GI disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption, Eosinophilic esophagitis
  • Subjects 6-11 years old unable to swallow tablets

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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