Condition category
Digestive System
Date applied
04/08/2005
Date assigned
04/08/2005
Last edited
10/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl/

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

Publication citations

Additional files

Editorial Notes