Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000244505
Ethics application status
Approved
Date submitted
13/06/2006
Date registered
19/06/2006
Date last updated
14/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Travelan & Ulcerative Colitis
Scientific title
An open label study to assess the efficacy of Travelan as an adjunct therapy to reduce inflammation in Ulcerative Colitis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 1221 0
Condition category
Condition code
Oral and Gastrointestinal 1305 1305 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ravelan tablets 200mg x 6 daily (3TDS) orally for 2 months.
Participants have:
Baseline measurements
one month pre-intervention observation,
two months intervention, then
one month post-intervention observation.
Data gathered during the initial month of observation allows each individual to act as his own control.
Intervention code [1] 1132 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Active

Outcomes
Primary outcome [1] 1785 0
20% reduction in laboratory markers (serum inflammatory markers)
Timepoint [1] 1785 0
Measured at baseline then monthly. Outcome effect will be determined after 2 months intervention, then confirmed after a post-intervention observation period of one month.
That is: one month preintervention observation & measurement, 2 months intervention & measurement, one month post intervention observation & measurement.
Secondary outcome [1] 3139 0
20% reduction in symptoms according to patient's self assessment records
Timepoint [1] 3139 0
Measured at baseline, then after one month of pre-intervention observation. Outcomes determined after 2 months intervention & measuremnt then further reassessed after one month post intervention observation and measurements.
Secondary outcome [2] 3140 0
20% change in antibody levels within the gut (stool samples)
Timepoint [2] 3140 0
Measured at baseline, then after one month of pre-intervention observation. Outcomes determined after 2 months intervention & measuremnt then further reassessed after one month post intervention observation and measurements.
Secondary outcome [3] 3141 0
A reduction of faecal blood loss
Timepoint [3] 3141 0
Measured at baseline, then after one month of pre-intervention observation. Outcomes determined after 2 months intervention & measuremnt then further reassessed after one month post intervention observation and measurements.

Eligibility
Key inclusion criteria
Mild to moderate ulcerative colitis (UC)* diagnosed with UC at least 12 months previously* diagnosis on clinical grounds confirmed by colonoscopy within last 2 years* UC with a modified Mayo score >4.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe ulcerative colitis* any major gastrointestinal surgery* partial bowel obstruction* patients with co-existing non-intestinal inflammatory disease (eg disease assoc with elevated ESR)* pregnancy or breast feeding* alcohol or drug abuse* smoker* significant allergy to cow's milk* insistence on maintaining Probiotic intake during study* treated with oral steroids within 2 weeks of commencing screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
After 4 weeks on study medication patients are reviewed for 20% improvement in efficacy using diary score. If they have not reached target, the dose is trebled for the second month. (Amendment submitted Feb 2008)
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 338 0
Israel
State/province [1] 338 0
Tel Aviv

Funding & Sponsors
Funding source category [1] 1432 0
Commercial sector/Industry
Name [1] 1432 0
Anadis Ltd
Country [1] 1432 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Anadis Ltd
Address
4 Capital Link Drive
Campbellfield VIC 3061
Country
Australia
Secondary sponsor category [1] 1263 0
None
Name [1] 1263 0
Nil
Address [1] 1263 0
Country [1] 1263 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35740 0
Address 35740 0
Country 35740 0
Phone 35740 0
Fax 35740 0
Email 35740 0
Contact person for public queries
Name 10321 0
Ms Angela Gibbs, co-ordinator
Address 10321 0
Department of Gastroenterology
St Vincent's Hospital
Fitzroy VIC 3061
Country 10321 0
Australia
Phone 10321 0
+61 3 92883592
Fax 10321 0
Email 10321 0
angela.gibbs@svhm.org.au
Contact person for scientific queries
Name 1249 0
Dr Grant Rawlin, Gen Manager R&D
Address 1249 0
Anadis Ltd
4 Capital Link Dve
Campbellfield VIC 3065
Country 1249 0
Australia
Phone 1249 0
+61 3 93586388
Fax 1249 0
+61 3 93586399
Email 1249 0
grant.r@anadis.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.