|
ISRCTN
|
ISRCTN97214617
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Constipation in Distal Ulcerative Colitis: A clinico-radiological comparison of the effectiveness of fibre supplementation vs polyethylene glycol laxative
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0263128752
|
|
Study hypothesis
|
To determine whether polyethylene glycol laxative is superior to fibre supplementation in relieving constipation and improving colonic transit in patients with distal ulcerative colitis
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Digestive System: Ulcerative colitis
|
|
Participants - inclusion criteria
|
146 patients from Gastroenterology
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
12/08/2003
|
|
Anticipated end date
|
01/12/2006
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
146
|
|
Interventions
|
1. Fibre supplementation
2. Polyethylene glycol laxative
|
|
Primary outcome measure(s)
|
Assessment of improvement in colonic transit by radioopaque markers study at the end of 4 weeks of treatment
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
University College London Hospitals NHS Trust (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
S L
Bloom
|
|
Address
|
Gastroenterology
G.I. Unit, 2nd Floor
The Middlesex Hospital
Mortimer Street
|
|
City/town
|
London
|
|
Zip/Postcode
|
W1N 8AA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7380 9126
|
|
Fax
|
+44 (0)20 7380 9162
|
|
Email
|
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
|
|
Address
|
The Department of Health,
Richmond House,
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
30/09/2004
|
|
Last edited
|
13/04/2011
|
|
Date ISRCTN assigned
|
30/09/2004
|