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

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05267613
Collaborator
IQVIA RDS Inc. (Other), Calyx (Other), Laboratory Corporation of America (Industry), Medidata Solutions (Industry), Thermo Fisher Scientific, Inc (Industry), CISCRP (Center for Information and Study on Clinical Research Participation) (Other), Quipment Inc. (Other), Little Journey Ltd. (Other)
100
Enrollment
44
Locations
2
Arms
50.1
Anticipated Duration (Months)
2.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Nexium 20mg
  • Drug: Nexium 10mg
 Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated 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
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Aug 14, 2026
Anticipated Study Completion Date :
Sep 3, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Presence / absence of Erosive Esophagitis [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 [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 [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

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site Sacramento California United States 95817
2 Research Site Miami Florida United States 33155
3 Research Site Orlando Florida United States 32806
4 Research Site Carmel Indiana United States 46290
5 Research Site Cleveland Ohio United States 44195
6 Research Site Milwaukee Wisconsin United States 53226
7 Research Site Cordoba Argentina 5000
8 Research Site Córdoba Argentina X5016KEH
9 Research Site Parana Argentina 3100
10 Research Site Rosario Argentina S2000DEJ
11 Research Site Clayton Australia 3168
12 Research Site North Adelaide Australia 5006
13 Research Site Namur Belgium 5101
14 Research Site Athens Greece 11527
15 Research Site Thessaloniki Greece 54642
16 Research Site Thessaloniki Greece 56249
17 Research Site Messina Italy 98125
18 Research Site Napoli Italy 80131
19 Research Site Napoli Italy 80138
20 Research Site Roma Italy 00137
21 Research Site Roma Italy 00161
22 Research Site Kaunas Lithuania LT50009
23 Research Site Vilnius Lithuania LT-08406
24 Research Site Braga Portugal 4710
25 Research Site Coimbra Portugal 3000-602
26 Research Site Lisboa Portugal 1169-045
27 Research Site Lisboa Portugal 1500-650
28 Research Site Lisboa Portugal 1998-018
29 Research Site Porto Portugal 4099-001
30 Research Site Porto Portugal 4200-319
31 Research Site Viana do Castelo Portugal 4901-858
32 Research Site Novosibirsk Russian Federation 630007
33 Research Site Pyatigorsk Russian Federation 357502
34 Research Site Saint Petersburg Russian Federation 196240
35 Research Site Saint-Petersburg Russian Federation 196158
36 Research Site Tomsk Russian Federation 634009
37 Research Site Badalona Spain 08916
38 Research Site Santiago de Compostela Spain 15706
39 Research Site Sevilla Spain 41009
40 Research Site Sevilla Spain 41013
41 Research Site Ha Noi Vietnam 100000
42 Research Site Hanoi Vietnam 100000
43 Research Site Hanoi Vietnam 10000
44 Research Site Hochiminh Vietnam

Sponsors and Collaborators

  • AstraZeneca
  • IQVIA RDS Inc.
  • Calyx
  • Laboratory Corporation of America
  • Medidata Solutions
  • Thermo Fisher Scientific, Inc
  • CISCRP (Center for Information and Study on Clinical Research Participation)
  • Quipment Inc.
  • Little Journey Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT05267613
Other Study ID Numbers:
  • D9612C09998
First Posted:
Mar 4, 2022
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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:
Esophagitis
Esomeprazole

Study Results

No Results Posted as of Aug 11, 2022