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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR2857 |
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Date of registration:
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18/04/2011 |
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Primary sponsor: |
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Public title:
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Effect of Prucalopride on esophagus in healthy volunteers.
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Scientific title:
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Effect of Prucalopride on Gastroesophageal Reflux, Esophageal Motility and Gastric Emptying in Healthy Volunteers. -
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Date of first enrolment:
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1/6/2011 |
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Target sample size:
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20 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2857 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Placebo; Group: Crossover; Type: Single arm
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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A.J.
Bredenoord |
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Address:
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Meibergdreef 9
1105 AZ
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5661745 |
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Email:
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a.j.bredenoord@amc.nl |
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Affiliation:
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Name:
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A.J.
Bredenoord |
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Address:
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Meibergdreef 9
1105 AZ
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5661745 |
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Email:
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a.j.bredenoord@amc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Functional dyspepsia (FD), Gastroesophageal reflux Disease (GERD), Gastric emptying, Heartburn
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Intervention(s)
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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.
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Primary Outcome(s)
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Number of esophageal reflux episodes during the 24-hr study.
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Secondary Outcome(s)
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1. Gastric emptying rate;
2. Esophageal contraction amplitudes;
3. LES resting pressure;
4. Esophageal acid exposure time;
5. Number of TLESRs.
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Secondary ID(s)
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2011-001870-25
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Source(s) of Monetary Support
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Shire/Movetis
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