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
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