The effect of Marinol (tetra-9-hydrocannabinol) on the frequency of transient lower oesophageal sphincter relaxations (TLESRs)

ISRCTN ISRCTN34437109
DOI https://doi.org/10.1186/ISRCTN34437109
Secondary identifying numbers NTR52
Submission date
04/08/2005
Registration date
04/08/2005
Last edited
10/06/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr G.E.E. Boeckxstaens
Scientific

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Phone +31 (0)20 566 7375
Email g.e.boeckxstaens@amc.uva.nl

Study information

Study designDouble-blind, placebo-controlled, crossover, randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesCannabinoid 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.
Health condition(s) or problem(s) studiedGastro-oesophageal reflux disease (GERD)
InterventionTwice 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Marinol
Primary outcome measureFrequency of TLESRs measured by oesophageal manometry up to three hours post-prandially.
Secondary outcome measuresRate 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 date03/05/2004
Completion date01/06/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit55 Years
SexMale
Target number of participants18
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment03/05/2004
Date of final enrolment01/06/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Centre (AMC) (The Netherlands)
University/education

Emma Kinderziekenhuis
Postbus 22660
Amsterdam
1105 AZ
Netherlands

Website http://www.amc.uva.nl/
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Industry

AstraZeneca R&D Mölndal (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan