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Sponsored by: |
AstraZeneca |
---|---|
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00687245 |
The purpose of this study is to determine the area under the plasma concentration-time curve (AUC) of esomeprazole after single oral doses of 5 mg, 10 mg or 20 mg esomeprazole in pediatric patients 1 to 11 years-old inclusive with endoscopically-proven GERD.
Condition | Intervention | Phase |
---|---|---|
Endoscopically-Proven GERD Reflux |
Drug: esomeprazole magnesium |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
Official Title: | A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Single Oral Doses of Esomeprazole Magnesium in Pediatric Patients 1 to 11 Years-Old Inclusive With Endoscopically-Proven Gastroesophageal Reflux Disease (GERD) |
Enrollment: | 40 |
Study Start Date: | August 2006 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
esomeprazole magnesium 5 mg, weight 8 kg to < 20kg
|
Drug: esomeprazole magnesium
capsules, oral, qd, one day
|
2: Experimental
esomeprazole magnesium 10 mg, weight 8 kg to < 20kg
|
Drug: esomeprazole magnesium
capsules, oral, qd, one day
|
3: Experimental
esomeprazole magnesium 10 mg, weight > 20 kg
|
Drug: esomeprazole magnesium
capsules, oral, qd, one day
|
4: Experimental
esomeprazole magnesium 20 mg, weight > 20 kg
|
Drug: esomeprazole magnesium
capsules, oral, qd, one day
|
Ages Eligible for Study: | 1 Year to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | AstraZeneca Pharmaceuticals ( Tore Lind, MD, Medical Science Director Nexium and GI Established Brands ) |
Study ID Numbers: | D9614C00007 |
Study First Received: | May 28, 2008 |
Last Updated: | June 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00687245 |
Health Authority: | United States: Food and Drug Administration |
children reflux GERD pediatric |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Esophageal disorder |
Gastrointestinal Diseases Omeprazole Esophageal Diseases Gastroesophageal Reflux |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Ulcer Agents |
Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |