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The effect of Marinol (tetra-9-hydrocannabinol) on the frequency of TLESRs.


- candidate number0
- NTR NumberNTR52
- ISRCTNISRCTN34437109
- Date ISRCTN created5-aug-2005
- date ISRCTN requested28-jul-2005
- Date Registered NTR31-mei-2005
- Secondary IDsMEC 04/084 
- Public TitleThe effect of Marinol (tetra-9-hydrocannabinol) on the frequency of TLESRs.
- Scientific TitleThe effect of Marinol (tetra-9-hydrocannabinol) on the frequency of TLESRs.
- ACRONYMN/A
- hypothesisCannabinoid receptor (CB1) agonists, like marinol, lower the rate of TLESRs and can be useful in the treatment of gastroesophageal reflux disease (GERD).
- Healt Condition(s) or Problem(s) studiedGastroesophageal reflux Disease (GERD)
- Inclusion criteria1. Man,
2. 18-55 years,
3. 65-100kg,
4. bmi 19-30 kg/m2,
5. normal fysical and laboratorial findings at start of study.
- Exclusion criteria1. Clinical relevant illness two weeks prior to start of study;
2. systemic illness which influence esophageal motility;
3. use of drugs that influence gastrointestinal motility;
4. drug abuse,
5. mania, depression, schizofrenia or another mental illness; 6. cardiac complaints as hypo-. hypertension, syncope, tachycardia;
7. cannabis allergy,
8. sesame oil allergy or another severe allergy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 3-mei-2004
- planned closingdate1-jun-2005
- Target number of participants18
- InterventionsTwice a 4 hours esophageal manometry and pH-metry (transnasally).
Single dose of 10mg marinol (delta-9-hydrocannabinol, THC) and a single dose of placebo.
- Primary outcomeFrequency of transient lower esophageal sfincter relaxations (TLESRs) measured by esophageal manometry up to 3hours postprandially.
- Secondary outcomeRate of acid reflux episodes measured with pH-metry for 3 hours postprandially, basal lower esophageal sphincter pressure (LESp) measured by manometry.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. G.E.E. Boeckxstaens
- CONTACT for SCIENTIFIC QUERIESDr. G.E.E. Boeckxstaens
- Sponsor/Initiator Academic Medical Center (AMC), Motility Center, Department of Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
AstraZeneca R&D Mölndal, Sweden
- PublicationsN/A
- Brief summaryRemark randomization: Every subject is his own control.
- Main changes (audit trail)
- RECORD20-jul-2005 - 9-jul-2008


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