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Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagitis (EE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05267613
Recruitment Status : Recruiting
First Posted : March 4, 2022
Last Update Posted : June 3, 2022
Sponsor:
Collaborators:
IQVIA RDS Inc.
Calyx
Labcorp Central Laboratory Services
Medidata Solutions
Thermo Fisher Scientific
CISCRP (Center for Information and Study on Clinical Research Participation)
Quipment Inc.
Little Journey Ltd.
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The aim of this study is to determine if Nexium is safe and efficacious in maintaining healing of erosive esophagitis in patients 1 to 11 years of age.

Condition or disease Intervention/treatment Phase
Erosive Esophagitis Drug: Nexium 20mg Drug: Nexium 10mg Phase 3

Expanded Access : AstraZeneca has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Detailed Description:

Esomeprazole (NEXIUM™) is indicated for the maintenance of healing of endoscopy-verified erosive esophagitis (EE) in children 1 to 11 years of age in a number of countries worldwide, but not in the United States (US). The current study has been designed, in discussions with the Food and Drug Administration (FDA), to further evaluate the safety and efficacy of NEXIUM given as maintenance of healing of EE in children 1 to 11 years of age.

Safety assessments will include the monitoring of adverse events throughout the study, clinical laboratory testing (including hematology, clinical chemistry, urinalysis), vital signs (including blood pressure and pulse), and physical examination including weight.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Masking only applies to the double-blind, randomized maintenance phase of 16 weeks.
Primary Purpose: Treatment
Official Title: A Phase III Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagitis in Pediatric Patients 1 to 11 Years of Age
Estimated Study Start Date : June 30, 2022
Estimated Primary Completion Date : August 14, 2026
Estimated Study Completion Date : November 6, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nexium - high dose
Arm 1 (High dose = Healing dose)
Drug: Nexium 20mg
Nexium® (Esomeprazole) gastro-resistant granules for oral suspension 10 or 20 mg taken once daily for 8 weeks, and then 10 or 5 mg taken once daily for 16 weeks.

Active Comparator: Nexium - Low dose
Arm 2 (Low dose = ½ healing dose)
Drug: Nexium 10mg
Nexium® (Esomeprazole) gastro-resistant granules for oral suspension 10 or 20 mg taken once daily for 8 weeks, and then 10 or 5 mg taken once daily for 16 weeks.




Primary Outcome Measures :
  1. Presence / absence of Erosive Esophagitis [ Time Frame: Week 24 (end of 16-week maintenance phase) ]
    Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 16-week maintenance phase


Secondary Outcome Measures :
  1. Presence/absence of Erosive Esophagitis [ Time Frame: Week 8 (end of healing phase) ]
    Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 8-week healing phase

  2. Percentage of days without rescue medication [ Time Frame: Week 8 (end of healing phase) and Week 16 (end of maintenance phase) ]
    The percentage of days without rescue medication during the 8-week healing phase and during the 16-week maintenance phase



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must be 1 to 11 years of age
  2. Patients must have a history of GERD for at least 3 months before the start of study
  3. For the healing phase: Patients must have confirmed presence of EE at endoscopy performed within one week of the start of the healing phase.
  4. For the maintenance phase: Patients must have completed the healing phase and have endoscopy-verified healed EE at the 8-week endoscopy visit.
  5. Patients must weigh ≥ 10 kg.
  6. Patients may be male or female.
  7. All postmenarcheal female patients must have a negative pregnancy test (urine) before starting treatment.
  8. Sexually active patients must be abstinent or maintain effective contraception from informed consent day up to the last day of IMP treatment.
  9. Patient's guardian must be capable of giving signed informed consent

Exclusion Criteria:

  1. Presence of other diseases, such as severe heart, lung, liver, renal, blood, or neurological disease or similar
  2. Significant clinical illness within 4 weeks prior to the start of treatment
  3. Any conditions that are predicted to require a surgery during the study period (from the day of informed consent to the day of the last scheduled visit)
  4. Previous total gastrectomy
  5. Anticipated need for concomitant therapy with PPIs (except for the IMPs), H2-receptor antagonists and other drugs outlined in EC#5 after enrollment in this study
  6. Participation in another clinical study with an IMP administered in the last 4 weeks before enrollment.
  7. Patients with a known hypersensitivity to NEXIUM, or any other PPI, or any of the excipients of the product
  8. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
  9. Judgment by the Investigator that the patient should not participate in the study if the patient or guardian is unlikely to comply with study procedures, restrictions, and requirements
  10. Previous screening, or enrollment and randomization in the present study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05267613


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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United States, California
Research Site Not yet recruiting
Sacramento, California, United States, 95817
United States, Florida
Research Site Not yet recruiting
Miami, Florida, United States, 33155
Research Site Not yet recruiting
Orlando, Florida, United States, 32806
United States, Indiana
Research Site Not yet recruiting
Carmel, Indiana, United States, 46290
United States, Ohio
Research Site Not yet recruiting
Cleveland, Ohio, United States, 44195
United States, Wisconsin
Research Site Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Argentina
Research Site Not yet recruiting
Cordoba, Argentina, 5000
Research Site Not yet recruiting
Córdoba, Argentina, X5016KEH
Research Site Not yet recruiting
Parana, Argentina, 3100
Research Site Not yet recruiting
Rosario, Argentina, S2000DEJ
Australia
Research Site Recruiting
Clayton, Australia, 3168
Research Site Not yet recruiting
North Adelaide, Australia, 5006
Belgium
Research Site Recruiting
Namur, Belgium, 5101
Greece
Research Site Recruiting
Athens, Greece, 11527
Research Site Recruiting
Thessaloniki, Greece, 54642
Research Site Recruiting
Thessaloniki, Greece, 56249
Italy
Research Site Not yet recruiting
Messina, Italy, 98125
Research Site Not yet recruiting
Napoli, Italy, 80131
Research Site Not yet recruiting
Napoli, Italy, 80138
Research Site Not yet recruiting
Roma, Italy, 00137
Research Site Not yet recruiting
Roma, Italy, 00161
Lithuania
Research Site Recruiting
Kaunas, Lithuania, LT50009
Research Site Recruiting
Vilnius, Lithuania, LT-08406
Portugal
Research Site Not yet recruiting
Braga, Portugal, 4710
Research Site Not yet recruiting
Coimbra, Portugal, 3000-602
Research Site Not yet recruiting
Lisboa, Portugal, 1169-045
Research Site Not yet recruiting
Lisboa, Portugal, 1500-650
Research Site Not yet recruiting
Lisboa, Portugal, 1998-018
Research Site Not yet recruiting
Porto, Portugal, 4099-001
Research Site Not yet recruiting
Porto, Portugal, 4200-319
Research Site Not yet recruiting
Viana do Castelo, Portugal, 4901-858
Russian Federation
Research Site Suspended
Novosibirsk, Russian Federation, 630007
Research Site Suspended
Pyatigorsk, Russian Federation, 357502
Research Site Suspended
Saint Petersburg, Russian Federation, 196240
Research Site Suspended
Saint-Petersburg, Russian Federation, 196158
Research Site Suspended
Tomsk, Russian Federation, 634009
Spain
Research Site Recruiting
Badalona, Spain, 08916
Research Site Recruiting
Santiago de Compostela, Spain, 15706
Research Site Recruiting
Sevilla, Spain, 41009
Research Site Recruiting
Sevilla, Spain, 41013
Vietnam
Research Site Not yet recruiting
Ha Noi, Vietnam, 100000
Research Site Not yet recruiting
Hanoi, Vietnam, 100000
Research Site Not yet recruiting
Hanoi, Vietnam, 10000
Research Site Not yet recruiting
Hochiminh, Vietnam
Sponsors and Collaborators
AstraZeneca
IQVIA RDS Inc.
Calyx
Labcorp Central Laboratory Services
Medidata Solutions
Thermo Fisher Scientific
CISCRP (Center for Information and Study on Clinical Research Participation)
Quipment Inc.
Little Journey Ltd.
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05267613    
Other Study ID Numbers: D9612C09998
First Posted: March 4, 2022    Key Record Dates
Last Update Posted: June 3, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Erosive Esophagitis
Gastroesophageal Reflux Disease
Healing
Maintenance
Esophagogastroduodenoscopy
Endoscopy
EGD
GERD
GERD in children
Additional relevant MeSH terms:
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Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action