Contact information
Type
Scientific
Primary contact
Dr Lesley A Houghton
ORCID ID
Contact details
University Department of Medicine
South Manchester University Hospitals NHS Trust
Withington Hospital
Nell Lane
Manchester
M20 2LR
United Kingdom
+44 (0)161 291 4020/5813 (sec)
lahoughton@man.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0226111711
Study information
Scientific title
A study to investigate the effect of hypnotically induced nausea on gastric emptying rate of a standard meal in normal healthy volunteers
Acronym
Study hypothesis
To assess the effect of hypnotically induced nausea on gastric emptying rate of a standard meal in normal healthy volunteers and to validate a new technique for the induction of nausea in a laboratory setting.
Ethics approval
Not provided at time of registration
Study design
Randomised placebo-controlled crossover study trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Nausea
Intervention
A randomised, placebo controlled crossover study design will be used - each subject will have their gastric emptying rate assessed on one visit in the control state and following hypnotic induction of nausea on the other.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
To determine whether hypnotically induced nausea delays gastric emptying in normal healthy control subjects.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/2002
Overall trial end date
21/01/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Eight healthy volunteers determined by detailed medical history, physical examination, electrocardiogram (ECG) and negative pregnancy test.
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
8
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/05/2002
Recruitment end date
21/01/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Withington Hospital
Manchester
M20 2LR
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
South Manchester University 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