Contact information
Type
Scientific
Primary contact
Dr G.E.E. Boeckxstaens
ORCID ID
Contact details
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 7375
g.e.boeckxstaens@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR52
Study information
Scientific title
Acronym
Study hypothesis
Cannabinoid receptor (CB1) agonists, like marinol, lower the rate of transient lower oesophageal sphincter relaxations (TLESRs) and can be useful in the treatment of gastro-oesophageal reflux disease (GERD).
Ethics approval
Ethics approval received from the local ethics committee.
Study design
Double-blind, placebo-controlled, crossover, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Gastro-oesophageal reflux disease (GERD)
Intervention
Twice a four-hour oesophageal manometry and pH-metry (transnasally). Single dose of 10 mg marinol (tetra-9-hydrocannabinol [THC]) and a single dose of placebo.
Intervention type
Drug
Phase
Not Specified
Drug names
Marinol
Primary outcome measures
Frequency of TLESRs measured by oesophageal manometry up to three hours post-prandially.
Secondary outcome measures
Rate of acid reflux episodes measured with pH-metry for three hours post-prandially, basal lower oesophageal sphincter pressure (LESp) measured by manometry.
Overall trial start date
03/05/2004
Overall trial end date
01/06/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male
2. Aged 18 - 55 years
3. 65 - 100 kg, body mass index (BMI) 19 - 30 kg/m^2
4. Normal physical and laboratorial findings at start of study
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
18
Participant exclusion criteria
1. Clinical relevant illness two weeks prior to start of study
2. Systemic illness which influence oesophageal motility
3. Use of drugs that influence gastrointestinal motility
4. Drug abuse, mania, depression, schizofrenia or another mental illness
5. Cardiac complaints such as hypotension, hypertension, syncope, tachycardia
6. Cannabis allergy, sesame oil allergy or another severe allergy
Recruitment start date
03/05/2004
Recruitment end date
01/06/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
Emma Kinderziekenhuis
Postbus 22660
Amsterdam
1105 AZ
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
AstraZeneca R&D Mölndal (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary