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 |
| Protocol serial number | NTR52 |
| Sponsor | Academic Medical Centre (AMC) (The Netherlands) |
| Funder | AstraZeneca R&D Mölndal (Sweden) |
- 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
Scientific
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 566 7375 |
|---|---|
| g.e.boeckxstaens@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind, placebo-controlled, crossover, randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Marinol |
| Primary outcome measure(s) |
Frequency of TLESRs measured by oesophageal manometry up to three hours post-prandially. |
| Key secondary outcome measure(s) |
Rate of acid reflux episodes measured with pH-metry for three hours post-prandially, basal lower oesophageal sphincter pressure (LESp) measured by manometry. |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | Male |
| Target sample size at registration | 18 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 03/05/2004 |
| Date of final enrolment | 01/06/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
