Condition category
Signs and Symptoms
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
14/03/2016
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 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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes

14/03/2016: No publications found, verifying study status with principal investigator