Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
22/04/2015
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

Mr Gerald Laden

ORCID ID

Contact details

Hyperbaric Medicine Unit
BUPA
Hull & East Ridings
Hull
HU10 7AZ
United Kingdom
-
gerardladen@aol.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084118523

Study information

Scientific title

A randomised controlled pilot study in the use of hyperbaric oxygen therapy versus metronidazole in chronic pouchitis

Acronym

Study hypothesis

To assess the benefits and effectiveness of hyperbaric oxygenation as a potential new treatment for chronic or refractory pouchitis.

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

Treatment

Patient information sheet

Condition

Pouchitis

Intervention

Randomised controlled trial comparing:
1. Hyperbaric oxygen therapy
2. Metronizadole

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

30/09/2002

Overall trial end date

10/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Total number required: 30

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

30/09/2002

Recruitment end date

10/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hyperbaric Medicine Unit
Hull
HU10 7AZ
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

Government

Funder name

The North and South Bank Research and Development Consortium (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