No registrations found.
ID
Source
Brief title
Intervention
Outcome measures
Primary outcome
Frequency of transient lower esophageal sfincter relaxations (TLESRs) measured by esophageal manometry up to 3hours postprandially.
Secondary outcome
Rate of acid reflux episodes measured with pH-metry for 3 hours postprandially, basal lower esophageal sphincter pressure (LESp) measured by manometry.
Background summary
Remark randomization: Every subject is his own control.
Study objective
Cannabinoid receptor (CB1) agonists, like marinol, lower the rate of TLESRs and can be useful in the treatment of gastroesophageal reflux disease (GERD).
Study design
N/A
Intervention
Twice a 4 hours esophageal manometry and pH-metry (transnasally).
Single dose of 10mg marinol (delta-9-hydrocannabinol, THC) and a single dose of placebo.
P.O. Box 22660
G.E.E. Boeckxstaens
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5667375
g.e.boeckxstaens@amc.uva.nl
P.O. Box 22660
G.E.E. Boeckxstaens
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5667375
g.e.boeckxstaens@amc.uva.nl
Inclusion criteria
1. 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 criteria
1. 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.
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 | NL30 |
| NTR-old | NTR52 |
| Other | : MEC 04/084 |
| ISRCTN | ISRCTN34437109 |