Condition category
Digestive System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
01/04/2009
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

Prof D J Nutt

ORCID ID

Contact details

C/O Research & Effectiveness Department
Level 1
The Old Building
Bristol Royal Infirmary
Malborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 928 3473
r&eoffice@ubht.swest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0264149443

Study information

Scientific title

Acronym

Study hypothesis

To explore whether traditional anxiolytic lorazepam administered orally prior to the procedure can attenuate fear and anxiety.

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

Not specified

Trial type

Treatment

Patient information sheet

Condition

Irritable bowel syndrome (IBS)

Intervention

Single, blind, placebo controlled trial of inhaled carbon dioxide with traditional anxiolytic lorazepam administered orally prior to the procedure.

Intervention type

Drug

Phase

Not Applicable

Drug names

Lorazepam

Primary outcome measures

Measurable fear using subjective ratings

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2004

Overall trial end date

01/08/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with irritable bowel syndrome (IBS)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Sample group: 12 patients with IBS and 12 healthy volunteers

Participant exclusion criteria

History of cardiovascular or respiratory disease

Recruitment start date

01/08/2004

Recruitment end date

01/08/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

C/O Research & Effectiveness Department
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

United Bristol Healthcare NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18609306

Publication citations

  1. Results

    Shufflebotham J, Wetherell MA, Hince D, Hood S, Lightman S, Nutt D, Probert C, Potokar J, Women with diarrhoea-predominant irritable bowel syndrome show an increased pressure response to 35% carbon dioxide stress challenge., Stress, 2009, 12, 1, 30-36, doi: 10.1080/10253890801976926.

Additional files

Editorial Notes