No registrations found.
ID
Source
Health condition
Gastroesophageal reflux disease (GERD)
Functional dyspepsia
Delayed Gastric emptying
Heartburn
Gastro oesophagale reflux zikete (GORZ)
Functionele dyspepsie
Vertraagde maagontlediging
Zuurbranden
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of esophageal reflux episodes during the 24-hr study.
Secondary outcome
1. Gastric emptying rate;
2. Esophageal contraction amplitudes;
3. LES resting pressure;
4. Esophageal acid exposure time;
5. Number of TLESRs.
Background summary
Double blind placebo controlled, randomized cross-over study. The study population will consist of 20 healthy male volunteers who will be measured in the AMC in Amsterdam. Aim of the study is to asses the effect of Prucalopride on esophageal contraction characterisitcs and lower esophageal sphincter pressure, gastric emptying and esophageal reflux parameters.
Study objective
Prucalopride accelerates gastric emptying and increases esophageal contraction amplitude and LES pressure and subsequently reduces gastroesophageal reflux.
Study design
Measurements will be performed after 5 days of either Prucalopride or placebo treatment and medication will be ingested each morning. In between the two treatments a wash out period of at least 7 days will be followed. On the first day subjects will arrive at the clinic in the morning after an overnight fast for the manometry test and impedance -pH test. the pH/impedance catheter will remain in situ to perform a 24 hour ambulatory measurement. On the second day the patient will arrive at the clinic in the morning and the pH/impedance catheter will be removed followed by a scintigraphy after a labeled meal.
Intervention
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.
A.J. Bredenoord
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5661745
a.j.bredenoord@amc.nl
A.J. Bredenoord
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5661745
a.j.bredenoord@amc.nl
Inclusion criteria
1. Written informed consent;
2. Minimum age 18 years;
3. Male gender.
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2718 |
| NTR-old | NTR2857 |
| Other | EudraCT : 2011-001870-25 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |