The Use of Lansoprazole to Treat Infants With Symptoms of Gastroesophageal Reflux

Gastroesophageal Reflux Disease Clinical Trial

Official title:

A Phase 3, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Study Assessing the Safety and Efficacy of Lansoprazole Microgranules Oral Suspension in Infants With Symptomatic Gastroesophageal Reflux

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324974
• Other study ID #: P-GI05-109
• Secondary ID: 2006-000957-23U1
• Status: Completed
• Phase: Phase 3
• First received: May 9, 2006
• Last updated: July 20, 2010
• Start date: June 2006
• Est. completion date: May 2007

Study information

• Verified date: July 2010
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationPoland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of lansoprazole microgranules oral suspension, once daily (QD), in infants with gastroesophageal reflux symptoms during a 4-week treatment period.

Description:

This study will be conducted by approximately 20 investigative sites in the U.S. and Poland. Participants who qualify will be randomized in equal proportions to receive either lansoprazole Pediatric Suspension (0.2-0.3 mg/kg/day in infants <10 weeks of age or 1.0-1.5 mg/kg/day in infants >10 weeks of age) or Placebo. This study consists of three periods: Pretreatment Period of 7-14 days, Double-Blind Treatment Period of 4 weeks (Dosing), and the Post-Treatment Period of 30 days (Follow-Up).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 11 Months

Eligibility

Inclusion Criteria:

• At least 7 days post-surgery at the time of Screening (Study Visit 1) with no anticipated need for surgery during the study.

• Experiencing symptoms of gastroesophageal reflux disease (regurgitation, vomiting or "spitting up," fussing/irritability, feeding refusal, crying during feeding, arching back, poor weight gain, or extraesophageal manifestations) or endoscopy proven reflux disease.

• Must continue to have reflux symptoms during the Pretreatment Period despite reducing or eliminating exposure to tobacco smoke, using one positioning and feeding strategy the last 7 days as documented in the Daily Diary.

• The infant exhibited crying, fussing, or irritability during or within 1 hour of feeding in >25% of all feedings during the last 4 days of the Pretreatment Period as documented in the Daily Diary.

Exclusion Criteria:

• Body weight <2.0 kilogram at Dosing Day 1 of the Double-Blind Treatment Period.

• Unstable, congenital or acquired, clinically significant disease of any major organ system (cardiovascular, respiratory, renal, hepatic, metabolic, etc.), including suspected and/or documented culture-proven sepsis.

• Coexisting esophageal disease (e.g., eosinophilic esophagitis, viral, bacterial or fungal infection) or caustic or physiochemical trauma to the esophagus.

• Any congenital anomaly of the upper gastric intestinal tract that might interfere with gastrointestinal motility, pH, absorption, or active or known history of necrotizing enterocolitis that has been surgically corrected.

• Use of a proton pump inhibitor within 30 days prior to Dosing Day 1.

• Use of H2 Blockers (i.e. Zantac) within 7 days prior to Dosing Day 1.

• Allergy to proton pump inhibitors (i.e. Prilosec, Prevacid).

• Use of prokinetics (e.g., metoclopramide) unless on a stable dose for at least 3 days prior to entering the Pretreatment Period.

• Unable to obtain stable drug levels after continuous treatment with required drugs including theophylline derivatives, digoxin, phenytoin, phenobarbital, or carbamazepine within the 7 days prior to Dosing Day 1.

• Clinically Significant abnormalities in clinical laboratory values.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Lansoprazole microgranules suspension
Lansoprazole microgranules 0.2-0.3 mg/kg/day suspension, orally, once daily for up to 28 days for infants less than 10 weeks; Lansoprazole microgranules 1.0-1.5 mg/kg/day suspension, orally, once daily for up to 28 days for infants greater than 10 weeks.
• Placebo
Lansoprazole placebo-matching suspension, orally, once daily for up to 28 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

United States,  Poland, 

References & Publications (1)

Orenstein SR, Hassall E, Furmaga-Jablonska W, Atkinson S, Raanan M. Multicenter, double-blind, randomized, placebo-controlled trial assessing the efficacy and safety of proton pump inhibitor lansoprazole in infants with symptoms of gastroesophageal reflux — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects in each treatment group responding to treatment with a reduction from baseline in the percentage and duration of crying/fussing/irritability episodes associated with feeding after 4 weeks of treatment.		Week 4	No
Primary	Safety Assessments		Baseline through week 8	Yes
Secondary	Global Symptom Assessment, as answered by Investigator and Parent/Guardian		Baseline through Week 8	No
Secondary	Sensitivity analyses of the primary endpoint		Week 4	No
Secondary	Additional Daily Diary-based symptom Assessments		At the end of the double-blind treatment period and 30 days after the last dose of study drug.	No
Secondary	Indicators of Growth Parameters		During and at the end of the Double-blind treatment period and 30 days after the last dose of study drug.	No

External Links

•   FDA Safety Alerts and Recalls