Double-blind randomised evaluation of clinical tolerance (taste) of PEG 4000 and PEG 3350 in children with constipation

Double-blind randomised evaluation of clinical tolerance (taste) of PEG 4000 and PEG 3350 in children with constipation - Clinical tolerance of PEG 4000 and PEG 3350

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30493

Enrollment

427

Registered

2007-08-17

Start date

2007-06-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

constipation

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Functional constipation as defined by the Rome III criteria Age 4-12 years

Exclusion criteria

Exclusion criteria: Children who received PEG 4000 or PEG 3350 during the last 2 weeks before intake.

Design outcomes

Secondary

Measure	Time frame
Secondary outcome parameters * Frequency of lemonade as an add-on * Time required for administration of the drug * PEG Preference (T= 4)	—

Primary

Measure	Time frame
Primary outcome parameters: * PEG Preference (T=0) * Constipation * Compliance Lemonade add-on is considered as a non-compliance towards the product when seen in a frequency exceeding the 40%	—

Countries

Netherlands

Outcome results