Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

NCT00226044 | Completed Phase 3

• 1 other identifier: LTC-001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy of oral and rectal omeprazole treatment in infants with gastroesophageal reflux due to esophageal atresia or congenital diaphragmatic hernia.

Conditions

Gastroesophageal Reflux; Esophageal Atresia; Hernia, Diaphragmatic

Keywords

Omeprazole, suppository, infants

Outcome Measures

Primary Outcomes (1)

• Therapeutic efficacy

  Primary: percentage of infants for which omeprazole was effective according to predefined criteria for 24 hour intraesophageal pH.

  24 hour

Secondary Outcomes (4)

• Intragastric pH

  24 hours

• Maximum plasma concentration (Cmax)

  8 hours

• Time to reach Cmax (Tmax)

  8 hours

• Area under the curve (AUC)

  8 hours

Study Arms (2)

Oral omeprazole

NO INTERVENTION

Standard of care: A single dose of 1 mg/kg orally administered omeprazole.

Rectal omeprazole

ACTIVE COMPARATOR

A single dose of 1 mg/kg rectally administered omeprazole.

Drug: Omeprazole rectally 1mg/kg

Interventions

Omeprazole rectally 1mg/kg DRUG

A single dose of 1 mg/kg rectally administered omeprazole.

Rectal omeprazole

Eligibility Criteria

• Age: 6 Weeks - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Infants were eligible for the study if they were: * 6-12 weeks postnatal age * weighed more than 3 kg * were after surgical repair for EA or CDH * showed clinical GERD * were to undergo the 48 hour pH measurements. Infants were excluded if they were: * allergic to omeprazole * participated in other interventional trials * used medications known to interact with omeprazole.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Rijnstate Hospital: lead
• Erasmus Medical Center: collaborator

Study Sites (1)

Erasmus Medical center

Rotterdam, 3015 GD, Netherlands

Location

Related Publications (1)

• Bestebreurtje P, de Koning BAE, Roeleveld N, Knibbe CAJ, Tibboel D, van Groen B, van de Ven CP, Plotz FB, de Wildt SN. Rectal Omeprazole in Infants With Gastroesophageal Reflux Disease: A Randomized Pilot Trial. Eur J Drug Metab Pharmacokinet. 2020 Oct;45(5):635-643. doi: 10.1007/s13318-020-00630-8.

  PMID: 32594305 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Esophageal Atresia; Hernia, Diaphragmatic

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• S.N. de Wildt, Prof. Dr.

  Erasmus Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study was an open-label randomized intervention trial to study the efficacy of a single oral or rectal administered omeprazole dose of 1 mg/kg in infants with GERD due to EA or CDH.

Study Record Dates

• First Submitted: September 22, 2005
• First Posted: September 26, 2005
• Study Start: September 1, 2005
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2017
• Last Updated: October 7, 2019

Record last verified: 2019-10

Locations

NL (1)