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Effect of Prucalopride on esophagus in healthy volunteers.


- candidate number9343
- NTR NumberNTR2857
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-apr-2011
- Secondary IDs2011-001870-25 EudraCT
- Public TitleEffect of Prucalopride on esophagus in healthy volunteers.
- Scientific TitleEffect of Prucalopride on Gastroesophageal Reflux, Esophageal Motility and Gastric Emptying in Healthy Volunteers.
- ACRONYM
- hypothesisPrucalopride accelerates gastric emptying and increases esophageal contraction amplitude and LES pressure and subsequently reduces gastroesophageal reflux.
- Healt Condition(s) or Problem(s) studiedFunctional dyspepsia (FD), Gastroesophageal reflux Disease (GERD), Gastric emptying, Heartburn
- Inclusion criteria1. Written informed consent;
2. Minimum age 18 years;
3. Male gender.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jun-2011
- planned closingdate1-jun-2013
- Target number of participants20
- Interventions1. 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.
- Primary outcomeNumber of esophageal reflux episodes during the 24-hr study.
- Secondary outcome1. Gastric emptying rate;
2. Esophageal contraction amplitudes;
3. LES resting pressure;
4. Esophageal acid exposure time;
5. Number of TLESRs.
- TimepointsMeasurements 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.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. A.J. Bredenoord
- CONTACT for SCIENTIFIC QUERIESDr. A.J. Bredenoord
- Sponsor/Initiator Academic Medical Center (AMC), Department of Hepato- and Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
Shire/Movetis
- PublicationsN/A
- Brief summaryDouble 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.
- Main changes (audit trail)
- RECORD18-apr-2011 - 19-dec-2012


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