Condition category
Digestive System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
15/11/2011
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 Elspeth Guthrie

ORCID ID

Contact details

Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
+44 (0)161 276 5382

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

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

Not Specified

Patient information sheet

Condition

Inflammatory bowel disease

Intervention

Psychotherapeutic intervention plus standard medical treatment versus standard medical treatment plus supportive listening.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/1992

Overall trial end date

31/05/1993

Reason abandoned

Eligibility

Participant inclusion criteria

1. Abdominal pain
2. Abdominal distention
3. Abnormal bowel habit associated with normal haematology, serum biochemistry, rectal biopsy and colonoscopy
4. Patients must have had symptoms for at least a year

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Severe depression with suicidal ideas

Recruitment start date

01/04/1992

Recruitment end date

31/05/1993

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Manchester Royal Infirmary
Manchester
M13 9WL
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
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.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive North West (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

1993 results in http://www.ncbi.nlm.nih.gov/pubmed/11346322

Publication citations

  1. Results

    Creed F, Ratcliffe J, Fernandez L, Tomenson B, Palmer S, Rigby C, Guthrie E, Read N, Thompson D, Health-related quality of life and health care costs in severe, refractory irritable bowel syndrome., Ann. Intern. Med., 2001, 134, 9 Pt 2, 860-868.

Additional files

Editorial Notes