Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0217101260
Study information
Scientific title
Nutrient modulation of sensory responses of the human oesophagus
Acronym
Study hypothesis
To determine whether intragastric or intraduodenal infusion of cholecystokinin (CCK)-releasing fatty acid (C12 or C14) modifies the threshold at which sensations are experienced in response to different oesophageal stimuli, when compared to a non-CCK-releasing fatty acid (C10 or C8).
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Sensory responses of the human oesophagus
Intervention
Extended pilot study consisting of a series of randomised controlled studies.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
To confirm or refute the hypothesis that fatty acids have a differential effect on oesophageal sensations.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2001
Overall trial end date
31/05/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy male or female volunteers aged 20 - 60 years
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/06/2001
Recruitment end date
31/05/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hope Hospital
Salford
M6 8HD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Salford Royal Hospitals NHS Trust (UK)
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