Phase 3
Completed N=98
Phase 3/Safety & Efficacy of Esomeprazole in Infants
Gastroesophageal Reflux Disease (GERD)
Source: ClinicalTrials.gov NCT00468559 ↗
Enrolled (actual)
98
Serious AEs
3.9%
Results posted
Jun 2014
Primary outcomePrimary: Number of Participants Discontinuing Due to Symptom Worsening in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint) — 1; 6; 8; 12 Participants
Summary
The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD). This research study consists of a screening, open-label, and double-blind treatment withdrawal phase. The screening phase ensures the patient eligibility. No study medication is dispensed during the screening phase. During the open-label phase, patients are administered esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase, the patients are administered either his/her open-label dose or placebo. Double-blind means neither the physician, parent, or patient will know if patient is taking esomeprazole or placebo. The patient will have an equal chance of receiving esomeprazole or placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Discontinuing Due to Symptom Worsening in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint) |
1; 6; 8; 12; 9; 13 | — |
| SECONDARY Number of Participants Discontinuing Due to Any Reason, Including Symptom Worsening, in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint) |
1; 6; 8; 12; 9; 13 | — |
| SECONDARY Treatment Successes at the End of the 4-week Double-blind Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint). |
24; 21 | — |
| SECONDARY Physician's Global Assessment (PGA) of Gastroesophageal Reflux Disease (GERD) Symptoms (Treatment Withdrawal Phase Endpoint) |
10.3; 4.9; 51.3; 48.8; 25.6; 31.7 | — |
| SECONDARY Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint) |
0.040; 0.090 | — |
| SECONDARY Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint) |
0.060; 0.190 | — |
| SECONDARY Severity of Supraesophageal/Respiratory Disturbances (Coughing/Wheezing,Labored Breathing) as Reported by Parent/Guardian (Treatment Withdrawal Phase Endpoint) |
0.120; 0.030 | — |
| SECONDARY Severity of Feeding Difficulties Reported by Parent/Guardian (Treatment Withdrawal Phase Endpoint) |
0.090; 0.100 | — |
| SECONDARY Improvement in Physician's Global Assessment (PGA) Following Open-label Esomeprazole (Open-label Phase Endpoint) |
81 | — |
| SECONDARY Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Open-label Phase) |
1.42; 1.14; 1.00 | — |
| SECONDARY Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Open-label Phase Endpoint) |
1.50; 1.22; 1.02 | — |
| SECONDARY Severity of Supraesophageal/Respiratory Disturbances (Coughing/Wheezing,Labored Breathing) as Reported by Parent/Guardian (Open-label Phase Endpoint) |
0.54; 0.48; 0.44 | — |
| SECONDARY Severity of Feeding Difficulties as Reported by Parent/Guardian (Open-label Phase Endpoint) |
1.16; 0.94; 0.83 | — |
Eligibility Criteria
Inclusion Criteria
- patients' parents must sign the informed consent prior to the beginning of any study-related procedures (according to local regulations)
- patients must have symptoms at study entry and have a clinical diagnosis of suspected GERD, symptomatic GERD, or GERD proven by a test called an endoscopy, a test using a long tube inserted in the body for diagnostic exams
Exclusion Criteria
- patients who have used a PPI (proton pump inhibitors; used to reduce the amount of acid in the stomach) within 7 days before enrollment in the open label treatment phase (Day 0)
- patients with a history of acute life-threatening event
Data sourced from ClinicalTrials.gov (NCT00468559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.