Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
Not specified
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Marinol
Primary outcome measure
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 study start date
03/05/2004
Overall study end date
01/06/2005
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
55 Years
Sex
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|