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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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8 October 2021 |
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Main ID: |
EUCTR2006-005212-27-FR |
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Date of registration:
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19/01/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Treatment-withdrawal Study to Evaluate the Efficacy and Safety of Esomeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Infants Aged 1 to 11 months, Inclusive
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Scientific title:
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A phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Treatment-withdrawal Study to Evaluate the Efficacy and Safety of Esomeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Infants Aged 1 to 11 months, Inclusive |
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Date of first enrolment:
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03/05/2007 |
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Target sample size:
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100 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005212-27 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: Open-label phase during the 2 first weeks of the study
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Germany
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Patients’ parent/guardian must provide written informed consent prior to the execution of any study-related procedures (according to local regulations).
2. Patients must be either a term or post-term infant beyond the neonatal period but less than 12 months of age, or else be a preterm infant with a corrected gestational age of at least 44 weeks but less than 12 months and weigh between 3 kg and 12 kg, inclusive.
3. Patients must be symptomatic at study entry and have a clinical diagnosis of suspected GERD, symptomatic GERD, or endoscopically proven GERD, made by the investigator and based on the following factors: history, physical examination, symptoms identified during review of systems, laboratory test results, or information from diagnostic testing. Notes in patients’ medical records, along with other source documentation, will be used to support the diagnosis. Patients with erosive esophagitis should be evaluated on a case by case basis to determine eligibility for the treatment withdrawal phase of the study.
4. At least one of the symptoms of GERD must be present for at least twice a week for a 4-week duration in all patients eligible for the study (Section 4.6.4). In addition, these patients, in the opinion of the investigator, have failed a trial of standard anti-reflux measures (thickened feeds, elimination diet, positioning, etc.).
5. Patients with supraesophageal manifestations of GERD, including wheezing, should present with a clinical picture consistent with GERD.
6. The mother of patients being breast fed should undergo a trial of elimination diet for a reasonable amount of time (1-2 weeks) prior to the patient’s enrollment in the study.
7. Patients who, in the judgment of the investigator, would be considered for treatment with an acid suppression agent based on symptoms of pathological GER.
8. Patients and parents/guardians must be able to comply with all study procedures.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Patients who have used a PPI within 7 days prior to enrollment in the open label treatment phase (Day 0).
2. Patients who have used any prescription or over-the-counter treatment for symptoms of GERD, such as H2RAs or prokinetics, within 24 hours prior to enrollment in the open-label treatment phase (Day 0). Antacids may be used, except for those containing bismuth (e.g., Pepto Bismol® and Kaopectate®).
3. Patients with a history or a current need for resection or reconstructive surgery of the esophagus, stomach, duodenum, or jejunum.
4. Patients with a history of acute life-threatening events (ALTEs), e.g. apnea, near SIDS.
6. Patients with the following active diseases/conditions: gastrointestinal bleed, allergic gastroenteropathies, eosinophilic gastroenteritis bleeding disorders (or a history of these disorders), pyloric stenosis, active seizure disorder, acute pancreatitis, or meningitis.
7. Patients with any acute or chronic illness that, in the opinion of the investigator, would place the patient at risk because of their participation in the study or potentially confound the study data by including the patient.
8. Patients with acute respiratory distress within 72 hours prior to enrollment in the open label treatment phase (Day 0). These patients will be eligible to be re evaluated for inclusion once the acute symptoms have subsided. Patients with a recent RSV infection will be excluded unless they have a documented negative RSV test.
9. Patients with abnormal screening laboratory values will be excluded only if the investigator and/or sponsor determine that the abnormalities are unexplainable or are clinically important and would indicate that the patient would be at risk from study participation.
10. Patients with any condition that may require surgery during the course of the study.
11. Patients with a known hypersensitivity, allergy, or intolerance to any component of esomeprazole, omeprazole, or MAALOX or an equivalent age-appropriate non-Bismuth containing liquid antacid.
12. Patients who have used any other investigational compound within 28 days prior to the screening visit.
14. Patients whose parent or guardian refuses to sign the informed consent form or is unable to provide fully informed written consent.
15. Previous enrollment or randomization of treatment in the present study.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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This Phase III study will evaluate esomeprazole for reducing the esophageal and supraesophageal signs and symptoms of infantile gastro-esophageal reflux disease (GERD) in infants aged 1 to 11 months, inclusive.
MedDRA version: 8.1
Level: LLT
Classification code 10017885
Term: Gastrooesophageal reflux disease
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Intervention(s)
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Product Name: esomeprazole clinical trial capsule
Product Code: NA
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: esomeprazole
CAS Number: 161796-78-7
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: esomeprazole clinical trial capsule
Product Code: NA
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: esomeprazole
CAS Number: 161796-78-7
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: esomeprazole clinical trial capsule
Product Code: NA
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: esomeprazole
CAS Number: 161796-78-7
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: The secondary objective of this study is to evaluate the safety and tolerability of once daily esomeprazole in infants aged 1 to 11 months, inclusive, with GERD.
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Main Objective: The primary objective of this study is to evaluate the efficacy of once daily esomeprazole for reducing the esophageal and supraesophageal signs and symptoms of infantile GERD.
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Primary end point(s): In order to be eligible for randomization into the double-blind phase of the study, patients must have demonstrated a predetermined level of improvement. Patients will be discontinued from the double-blind phase if their symptoms worsen or for other safety reasons as determined by the investigator.
The primary efficacy variable for this study will be time from randomization to discontinuation due to symptom worsening in the randomized treatment-withdrawal phase.
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Secondary ID(s)
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D9614C00096
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 03/05/2007
Contact:
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