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Trial registered on ANZCTR


Registration number
ACTRN12607000617460
Ethics application status
Approved
Date submitted
26/11/2007
Date registered
29/11/2007
Date last updated
7/04/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase IIa examination of the effect of oral dosing of NV-52 on surrogate markers of inflammatory bowel disease (IBD) in patients with stable disease but with a consistent abnormality in one or more surrogate marker.
Scientific title
Phase IIa examination of the effect of oral dosing of NV-52 on surrogate markers of inflammatory bowel disease (IBD) in patients with stable disease but with a consistent abnormality in one or more surrogate marker.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's disease and Ulcerative Colitis 2570 0
Condition category
Condition code
Oral and Gastrointestinal 2678 2678 0 0
Crohn's disease
Oral and Gastrointestinal 2679 2679 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
NV-52 will be administered orally, once daily at a dose of 50mg/day for 4 weeks.
Intervention code [1] 2305 0
Treatment: Drugs
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3582 0
The primary objective is to assess the effect of NV-52 on one or more of the surrogate markers of IBD taken from patient blood and faecal collections. The surrogate markers are faecal calprotectin and C-Reactive Protein (CRP), Erythricyte Sedimentation Rate (ESR), platelets, fibrinogen, Interleukin 6 (IL-6), Tumour Necrosis Factor A (TNFa), Interleukin 1B (IL-1B), C3 and C4.
Timepoint [1] 3582 0
The levels of each surrogate marker will be measured at baseline. Then on day 1, day 7, day 14, day 28 and day 56.
Secondary outcome [1] 5997 0
The secondary objective is to assess the safety and tolerability of chronic dosing with NV-52. Safety and tolerability will be assessed by the number of adverse events and by standard medical examinations, blood tests.
Timepoint [1] 5997 0
Patients safety and tolerability will be monitored continually throughout the trial. Patients will be asked at every visit whether they have experienced any symptoms or illnesses. These symptoms or illnesses will be documented and monitored from screening, throughout the 28 days of treatment and at the follow up visit. Medical exams and routine blood tests will be performed at all visits.
Secondary outcome [2] 5998 0
The tertiary objective is to assess the oral absorption of NV-52 in a small population of IBD patients.
Timepoint [2] 5998 0
To measure absorption of NV-52 blood will be collected on day 1, day 7, day 14, and day 28.

Eligibility
Key inclusion criteria
1. healthy, (without clinically significant impairment in cardiac, liver or renal function, central nervous system, pulmonary, hematological, immunological, or vascular disease in addition to IBD, or current malignancy or malignancy within 5 years prior to screening) adults > 18 years old

2. presenting with either UC or CD affecting colon, ideally with an even distribution of both disease types across the patient population.

3. stable but active mild disease defined as: an abnormal level (as defined by the reference laboratory) of at least one of the surrogate markers at both screening visits (The abnormality must occur in the same marker at both screening visits.)

4. The patients’ assessment of their own disease will include evidence of active but mild and stable disease eg 1-2 stools/day more than usual, or occasional streaks of blood. Patients will be trained in using this scoring system.

5. The physician’s empirical (gestalt) assessment will categorise the patient as having mild overall disease.

6. patients must be able to understand the risks and benefits of the study and give written informed consent to participation

7. Subjects of childbearing potential that agree to use contraception, or ensure that their sexual partner be using contraception which must be either oral contraceptives, implantable hormonal contraceptives, or double-barrier methods throughout the trial
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. patients whose symptoms deteriorate to the point of acute relapse (CDAI > 200, UCAI > 4). 2. a change in current medication within the last 4 weeks. 3. the use of steroids (excluding inhaled asthma medications) within the last 4 weeks. 4. the use of biologicals (eg monoclonal antibodies) within the last 4 weeks. 5. the use of trial medications within the last four weeks. 6. the use of rectal preparations. 7. a return to normal levels of all surrogate markers (CRP, ESR, platelets and faecal calprotectin) during the screening period (Day -14 – Day +1) ie at least one surrogate marker must be elevated at day1. If the results of the samples collected on Day 1, prior to drug being administered, show that markers have returned to normal levels, the patient will be excluded. 8. pregnant or lactating women or subjects not using adequate contraception.

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
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 334 0
4101

Funding & Sponsors
Funding source category [1] 2817 0
Commercial sector/Industry
Name [1] 2817 0
Novogen Research Pty Ltd
Country [1] 2817 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Novogen Research Pty Ltd
Address
140 Wicks Road
North Ryde NSW 2113
Country
Australia
Secondary sponsor category [1] 2543 0
None
Name [1] 2543 0
Address [1] 2543 0
Country [1] 2543 0
Other collaborator category [1] 93 0
Hospital
Name [1] 93 0
Professor Tim Florin
Address [1] 93 0
Gastroenterology Unit
Mater Health Services Adult Hospital
South Brisbane QLD 4101
Country [1] 93 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4787 0
Mater Health Services HREC
Ethics committee address [1] 4787 0
Level 2 Aubigny Place
Mater Health Services
Raymond Terrace
South Brisbane 4101
Ethics committee country [1] 4787 0
Australia
Date submitted for ethics approval [1] 4787 0
21/11/2007
Approval date [1] 4787 0
06/02/2008
Ethics approval number [1] 4787 0

Summary
Brief summary
Trial website
www.novogen.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28203 0
Address 28203 0
Country 28203 0
Phone 28203 0
Fax 28203 0
Email 28203 0
Contact person for public queries
Name 11360 0
Ms Sharyn Grossman
Address 11360 0
Gastroenterology Unit
Mater Health Services Adult Hospital
South Brisbane QLD 4101
Country 11360 0
Australia
Phone 11360 0
+61 7 31638196
Fax 11360 0
Email 11360 0
[email protected]
Contact person for scientific queries
Name 2288 0
Professor Timothy Florin
Address 2288 0
Gastroenterology Unit
Mater Health Services Adult Hospital
South Brisbane QLD 4101
Country 2288 0
Australia
Phone 2288 0
+61 7 55718979
Fax 2288 0
Email 2288 0
[email protected]

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.