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

Completed

• Conditions: Gastro-oesophageal reflux disease (GERD); Digestive System; Gastro-oesophageal reflux disease

• Registration Number: ISRCTN34437109
• Lead Sponsor: Academic Medical Centre (AMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-04
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 18

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of TLESRs measured by oesophageal manometry up to three hours post-prandially.

Secondary Outcome Measures

Name	Time	Method
Rate of acid reflux episodes measured with pH-metry for three hours post-prandially, basal lower oesophageal sphincter pressure (LESp) measured by manometry.