A trial of position control therapy (PCT) for treatment of infantile gastro-oesophageal reflux - PCT for infants with reflux

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004633-24-NL

Enrollment

200

Registered

2008-07-23

Start date

2008-10-23

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastro-oesophageal reflux related symptoms MedDRA version: 9.1 Level: LLT Classification code 10017884 Term: Gastrooesophageal reflux MedDRA version: 9.1 Level: LLT Classification code 10017885 Term: Gastrooesophageal reflux disease MedDRA version: 9.1 Level: LLT Classification code 10017924 Term: Gastroesophageal reflux

Interventions

Trade Name: Losec Pharmaceutical Form: Capsule* Trade Name: Gaviscon Pharmaceutical Form: Oral suspension

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Parental/guardian written informed consent. • 0-6 months post-natal age. • Patients must have an observed clinical association of any two of: (1) apnoea +/- bradycardia +/- oxygen desaturations, (2) vomiting/gagging, (3) irritability/pain at least every second feed or at least twice every 8 hrs. • Clinical symptoms must be present for at least five days or increasing in frequency or severity over three days. 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

Exclusion criteria: • History of acute life threatening events. • Environmental exposure to cigarette smoke. • A history or a current need for resection or reconstructive surgery of the G.I. tract or with any condition that may require surgery during the course of the study. • Any condition that would make performance of the study procedures unsafe, or which would make it unlikely that the patient would complete the study procedures to the final day.

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess the effect of position control therapy on symptoms due to gastro-oesophageal reflux in infatns 0-6 months of age.;Secondary Objective: ;Primary end point(s): Questionnaire scores Numer of GOR episodes (liquid,mixed, gas, acid(pH 7)) and their temporal association with objectively measured symptoms.	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026