CompletedPhase 3

Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)

United States344 participantsStarted 2009-11

Plain-language summary

The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with placebo in the treatment of gastrointestinal esophageal reflux disease (GERD) in infants 1 to 11 months of age.

Who can participate

Age range1 Month – 11 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of suspected GERD, symptomatic GERD, or endoscopically or histologically proven GERD, based on frequent vomiting or regurgitation, with at least 1 of the following: a) poor weight gain, or b) irritability, excessive crying or disturbed sleep that both the parent(s) and the doctor consider abnormal (but not due to colic) * or c) refusal to eat even if hungry or arching of the back during meals * weight 2.5 kg to 15.0 kg * I-GERQ-R score \>16 * Have only 1 caregiver in addition to the parent(s) Exclusion Criteria: * History of confirmed acute life-threatening events due to GERD * Known narrowing of the opening from the stomach to the small intestines * Confirmed diagnosis of cow's milk allergy * Have taken PPIs or H2-blockers (a class of drugs that inhibit stomach acid production) or any of several drugs that affect the normal movement of the digestive tract (caffeine, theophylline, antacids, erythromycin, and others) within 3 days before entering the study * Have blood or urine test results that are well above or below the normal range for the infant

What they're measuring

Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward)

Timeframe: Baseline, Week 8

Change From Baseline in Weight-for-Age Z-Score (Double-blind Phase/ Baseline Observation Carried Forward)

Timeframe: Baseline, Week 8

Change From Baseline in I-GERQ-R Total Score (Double-blind Phase/ Baseline Observation Carried Forward)

Timeframe: Baseline, Week 8

Change From Baseline in in Weekly Average I-GERQ-DD Total Score (Double-blind Phase/ Baseline Observation Carried Forward)

Timeframe: Baseline, Week 8

Trial details

NCT IDNCT00992589

SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-11

Results submitted2012-11-15

View on ClinicalTrials.gov More Gastroesophageal Reflux trials

Who can participate

Age range1 Month – 11 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward)

Timeframe: Baseline, Week 8

Change From Baseline in Weight-for-Age Z-Score (Double-blind Phase/ Baseline Observation Carried Forward)

Timeframe: Baseline, Week 8

Change From Baseline in I-GERQ-R Total Score (Double-blind Phase/ Baseline Observation Carried Forward)

Timeframe: Baseline, Week 8

Change From Baseline in in Weekly Average I-GERQ-DD Total Score (Double-blind Phase/ Baseline Observation Carried Forward)

Timeframe: Baseline, Week 8