Effect of Prucalopride on Gastroesophageal Reflux, Esophageal Motility and Gastric Emptying in healthy volunteers

Effect of Prucalopride on Gastroesophageal Reflux, Esophageal Motility and Gastric Emptying in healthy volunteers - Effect of Prucalopride on esophagus in healthy volunteers

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35936

Enrollment

Registered

2011-11-02

Start date

2012-07-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Gastroesophageal reflux heartburn

Interventions

6 days placebo and 6 days of 4mg prucalopride once daily.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Written Informed Consent Minimum age 18 years Male gender

Exclusion criteria

Exclusion criteria: Abnormal renal function Surgery of the GI tract other than appendectomy or cholcystectomy Motlity disorders of the GI tract leading to delayed gastric emptying or altered intestinal motility A history of GI complaints Use of any medication with a potential effect on GI motility that can not be stopped for the duation of the study Participation in another study with exposure to radiation in the last year

Design outcomes

Primary

Measure	Time frame
Number of esophageal reflux episodes during the 24-hr study	—

Secondary

Measure	Time frame
Gastric emptying rate (t1/2 emptying time) Esophageal contraction amplitudes (proximal, middle and distal esophagus) LES resting pressure Esophageal acid exposure time (%time pH	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)