Phase
Condition
Heartburn (Pediatric)
Heartburn
Esophageal Disorders
Treatment
Nexium 10mg
Nexium 20mg
Clinical Study ID
Ages 1-11 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient must be 1 to 11 years of age
Patients must have a clinical history of GERD for at least 3 months before the startof study
For the healing phase: Patients must have confirmed presence of EE at endoscopyperformed within one week of the start of the healing phase.
For the maintenance phase: Patients must have completed the healing phase and haveendoscopy-verified healed EE at the 8-week endoscopy visit.
Patients must weigh ≥ 10 kg.
Patients may be male or female.
All postmenarcheal female patients must have a negative pregnancy test (urine)before starting treatment.
Sexually active patients must be abstinent or maintain effective contraception frominformed consent day up to the last day of study intervention.
Patient's guardian must be capable of giving signed informed consent
Exclusion
Exclusion Criteria:
Presence of other diseases, such as severe heart, lung, liver, renal, blood, orneurological disease or similar
Significant clinical illness within 4 weeks prior to the start of treatment
Any conditions that are predicted to require a surgery during the study period (fromthe day of informed consent to the day of the last scheduled visit)
Previous total gastrectomy
Anticipated need for concomitant therapy with PPIs (except for the IMPs),H2-receptor antagonists and other drugs outlined in EC#5 after enrollment in thisstudy
Participation in another clinical study with an IMP administered in the last 4 weeksbefore enrollment.
Patients with a known hypersensitivity to NEXIUM, or any other PPI, or any of theexcipients of the product
Involvement in the planning and/or conduct of the study (applies to both AstraZenecastaff and/or staff at the study site).
Judgment by the Investigator that the patient should not participate in the study ifthe patient or guardian is unlikely to comply with study procedures, restrictions,and requirements
Previous screening, or enrollment and randomization in the present study
Study Design
Study Description
Connect with a study center
Research Site
Cordoba, 5000
ArgentinaActive - Recruiting
Research Site
Córdoba, X5016KEH
ArgentinaActive - Recruiting
Research Site
Parana, 3100
ArgentinaActive - Recruiting
Research Site
Rosario, S2000DEJ
ArgentinaActive - Recruiting
Research Site
Clayton, 3168
AustraliaActive - Recruiting
Research Site
North Adelaide, 5006
AustraliaActive - Recruiting
Research Site
Brussels, 1090
BelgiumActive - Recruiting
Research Site
Namur, 5101
BelgiumActive - Recruiting
Research Site
Athens, 11527
GreeceActive - Recruiting
Research Site
Thessaloniki, 56249
GreeceActive - Recruiting
Research Site
Messina, 98125
ItalyActive - Recruiting
Research Site
Napoli, 80138
ItalyActive - Recruiting
Research Site
Roma, 00161
ItalyActive - Recruiting
Research Site
Kaunas, LT50009
LithuaniaActive - Recruiting
Research Site
Vilnius, LT-08406
LithuaniaActive - Recruiting
Research Site
Braga, 4710
PortugalActive - Recruiting
Research Site
Coimbra, 3000-602
PortugalActive - Recruiting
Research Site
Lisboa, 1169-045
PortugalActive - Recruiting
Research Site
Porto, 4099-001
PortugalActive - Recruiting
Research Site
Viana do Castelo, 4901-858
PortugalActive - Recruiting
Research Site
Novosibirsk, 630007
Russian FederationSuspended
Research Site
Pyatigorsk, 357502
Russian FederationSuspended
Research Site
Saint Petersburg, 196240
Russian FederationSite Not Available
Research Site
Saint-Petersburg, 196158
Russian FederationSuspended
Research Site
Tomsk, 634009
Russian FederationSuspended
Research Site
Badalona, 08916
SpainActive - Recruiting
Research Site
Santiago de Compostela, 15706
SpainActive - Recruiting
Research Site
Sevilla, 41009
SpainActive - Recruiting
Research Site
Fontana, California 92335
United StatesSite Not Available
Research Site
Orange, California 92868
United StatesSite Not Available
Research Site
Sacramento, California 95817
United StatesActive - Recruiting
Research Site
Miami, Florida 33155
United StatesSite Not Available
Research Site
Orlando, Florida 32806
United StatesActive - Recruiting
Research Site
Downers Grove, Illinois 60515
United StatesSite Not Available
Research Site
Carmel, Indiana 46290
United StatesActive - Recruiting
Research Site
Springfield, Massachusetts 01199-1001
United StatesSite Not Available
Research Site
Akron, Ohio 44308
United StatesActive - Recruiting
Research Site
Cleveland, Ohio 44195
United StatesActive - Recruiting
Research Site
Knoxville, Tennessee 37916
United StatesSite Not Available
Research Site
Dallas, Texas 75235
United StatesSite Not Available
Research Site
Salt Lake City, Utah 84132
United StatesSite Not Available
Research Site
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
Research Site
Ha Noi, 100000
VietnamActive - Recruiting
Research Site
Hanoi, 10000
VietnamActive - Recruiting
Research Site
Hochiminh,
VietnamActive - Recruiting
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