To asses the effect of Prucalopride on esophageal contraction characteristics and lower esophageal sphincter pressure, gastric emptying and esophageal reflux parameters in healthy male subjects
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of esophageal reflux episodes during the 24-hr study
Secondary outcome
Gastric emptying rate (t1/2 emptying time)
Esophageal contraction amplitudes (proximal, middle and distal esophagus)
LES resting pressure
Esophageal acid exposure time (%time pH < 4)
Number of TLESRs
Background summary
Treatment of GERD (gastroesophageal reflux disease) fails in a small proportion
of patients. As GERD is one of the most prevalent chronic disorders in the
Western world, this small proportion of therapy-resistent patients encompasses
a substantial part of the patient population and is it important to develope
new medication for this population.
The cause of GERD is multifactorial, and a lower low esophageal sphincter (LES)
pressure, weak esophageal peristalsis and slow gastric emptying may all play a
role.
Prucalopride is a 5-HT4 receptor agonist that stimulates intestinal motility.
Prucalopride (Resolor) recently received marketing authorization for the
symptomatic treatment of chronic constipation in women in whom laxatives fail
to provide adequate relief.
No studies have been performed on the effect of Prucalopride on the human
esophageal muscles and its sphincters and no data is present on the effect of
Prucalopride on reflux characteristics.
In theory, effects on gastric emptying, esophageal motiltity and reflux
characteristics could be expected with prucalopride as with treatment with
other 5-HT4 receptor agonists, suggesting that Prucalopride may be helpful for
the treatment of upper gastrointestinal motility disorders such as GERD and
functional dyspepsia
Hypothesis: Prucalopride accelerates gastric emptying and increases esophageal
contraction amplitudes and LES pressure and subsequently reduces
gastroesohageal reflux.
Study objective
To asses the effect of Prucalopride on esophageal contraction characteristics
and lower esophageal sphincter pressure, gastric emptying and esophageal reflux
parameters in healthy male subjects
Study design
Double blind placebo controlled, randomized cross-over design
Intervention
6 days placebo and 6 days of 4mg prucalopride once daily.
Study burden and risks
The risks of this study are very minor. Placement of the catheters could be
uncomfortable and participation takes time, but this will be compensated by 400
euros by completion of the study.
The radiation exposure of the labeled pancake is very small; it consists of
less than the natural annual radiation what is allowed per year for the Duch
population.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Written Informed Consent
Minimum age 18 years
Male gender
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
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2011-001870-25-NL |
| CCMO | NL36606.018.11 |