Effect of Prucalopride on esophagus in healthy volunteers.

Effect of Prucalopride on Gastroesophageal Reflux, Esophageal Motility and Gastric Emptying in Healthy Volunteers.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24265

Enrollment

Registered

2011-04-18

Start date

2011-06-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Gastroesophageal reflux disease (GERD) Functional dyspepsia Delayed Gastric emptying Heartburn Gastro oesophagale reflux zikete (GORZ) Functionele dyspepsie Vertraagde maagontlediging Zuurbranden

Interventions

1. High resolution manometry (esophageal function study)

2. Impedance-pH recording (reflux study)

3. Standardized meal during the manometry and impedance

4. Study medication/placebo: 4 mg a day during 6 days 5. Questionnaires

6. Scintygraphy.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Written informed consent; 2. Minimum age 18 years; 3. Male gender.

Exclusion criteria

Exclusion criteria: 1. Surgery of the GI tract other than appendectomy or cholecystectomy; 2. Motility disorders of the GI tract leading to delayed gastric emptying or altered intestinal motility; 3. A history of GI complaints; 4. Use of any medication with a potential effect on GI Motility that can not be stopped for the duration of the study with examination with 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
1. Gastric emptying rate; 2. Esophageal contraction amplitudes; 3. LES resting pressure; 4. Esophageal acid exposure time; 5. Number of TLESRs.	—

Contacts

Public ContactA.J. Bredenoord

Meibergdreef 9

a.j.bredenoord@amc.nl+31 (0)20 5661745

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)