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Trial registered on ANZCTR


Registration number
ACTRN12613001222730
Ethics application status
Approved
Date submitted
26/09/2013
Date registered
6/11/2013
Date last updated
30/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised, Double-blinded, Placebo-controlled Study of Kivia (Trademark) 575mg Zyactinase (Registered Trademark) Capsule for the Improvement of Digestive Health Parameters in Subjects with Irritable Bowel Syndrome with Constipation Symptoms
Scientific title
A phase III study to investigate the effect of daily ingestion of four then two Kivia (Trademark) 575mg Zyactinase (Registered Trademark) or placebo capsules on stool frequency and abdominal pain severity when given to subjects with constipation dominant Irritable Bowel Syndrome
Secondary ID [1] 283228 0
Nil
Universal Trial Number (UTN)
U1111-1148-1314
Trial acronym
IBS Discomfort Elimination Assessment (IDEA) Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Constipation dominant Irritable Bowel Syndrome (IBS-C) 290102 0
Condition category
Condition code
Oral and Gastrointestinal 290478 290478 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
Treatment Arm 1: Oral capsules of Zyactinase (Registered Trademark) (active ingredient ) 1150mg , twice daily for four weeks followed by 575mg twice daily for four weeks. Total treatment period is 8 weeks

Treatment Arm 2:Oral capsules of placebo 1150mg twice daily for four weeks followed by 575mg twice daily for four weeks. Total treatment period is 8 weeks.

Study drug will be administered at the beginning of each dose period and all unused medications and used packaging is to be returned at the end of each dose period.
Intervention code [1] 287960 0
Treatment: Drugs
Comparator / control treatment
Capsules of placebo 1150mg twice daily orally for four weeks then 575mg twice daily orally for four weeks
Control group
Placebo

Outcomes
Primary outcome [1] 290504 0
Overall responder rate for both increased weekly stool frequency of at least one complete spontaneous bowel movement (CSBM) AND decreased weekly average of worst abdominal pain of at least 30% from baseline using a Visual Analogue Scale (VAS) of 0-10 cm.
Timepoint [1] 290504 0
Daily from Screening to final visit at week 12
Secondary outcome [1] 304650 0
Subjects with adequate weekly control of symptoms as assessed by daily Diary records of response to directed question.
Timepoint [1] 304650 0
At baseline and every day after start of study treatment for 10 weeks
Secondary outcome [2] 304651 0
Weekly average worst abdominal pain and worst abdominal discomfort using a Visual Analogue Scale (VAS) of 0-10 cm.
Timepoint [2] 304651 0
Daily from Screening to final visit at week 12.
Secondary outcome [3] 304652 0
Change in stool form by week using the 7-Category Bristol Stool Scale
Timepoint [3] 304652 0
Daily from Screening to final visit at week 12.
Secondary outcome [4] 304653 0
Abdominal pain-free days and abdominal discomfort-free days by week during the treatment period as assessed by daily Diary records.
Timepoint [4] 304653 0
Daily from Screening to final visit at week 12.
Secondary outcome [5] 304656 0
Severity of bowel urgency, of abdominal bloating, of abdominal of distension and of flatulence using a Visual Analogue Scale (VAS) of 0-10 cm.
Timepoint [5] 304656 0
Daily from Screening to final visit at week 12.
Secondary outcome [6] 304657 0
Frequency of straining at stool using VAS scale of 0-10 cm.
Timepoint [6] 304657 0
Daily from Screening to final visit at week 12.
Secondary outcome [7] 304658 0
Subject and Physician Global Assessment IBS-C and subject satisfaction with bowel function as assessed by Diary records of subject response to directed question.
Timepoint [7] 304658 0
Baseline and end of study treatment at week 8.
Secondary outcome [8] 304659 0
Weekly responder rate (CSBM and abdominal pain combined and individually) as assessed by subject daily Diary records of number of bowel movements and VAS scales.
Timepoint [8] 304659 0
Daily from Screening to final visit at week 12.
Secondary outcome [9] 304660 0
Time to first bowel movement as assessed by daily Diary records.
Timepoint [9] 304660 0
Daily from Screening to final visit at week 12.
Secondary outcome [10] 304661 0
Use of rescue medication during the study as assessed by daily Diary records.
Timepoint [10] 304661 0
Daily from Screening to final visit at week 12.

Eligibility
Key inclusion criteria
Subjects diagnosed with IBS-C according to Rome III criteria Abdominal pain intensity in past 24 hour score of >3.0 using VAS scale during screening

Subject swith Fewer than 3 Complete Spontaneous Bowel Movements per week during screening
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diarrhoea predominant or alternating IBS
Significant GI condition or serious systemic illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects meeting eligibility criteria will be randomised to treatment by the PI, 1:1 (study drug: placebo) online via the eCRF system.
Each investigational site will be allocated blocks of centrally computer generated randomised treatment packs which will be dispensed sequentially.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not applicable
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was calculated using a chi-square analysis as the test.

Demographic and other data recorded at Screening and Randomisation will be summarised and tabulated by randomised treatment group using common descriptive statistics. The analysis for the primary and secondary efficacy endpoints and the safety data will be performed according to the clinical study protocol and the approved Statistical Analysis Plan.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/11/2013
Actual
18/12/2013
Date of last participant enrolment
Anticipated
1/09/2014
Actual
7/04/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
187
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 1550 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [2] 1552 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 2278 0
Nepean Hospital - Kingswood
Recruitment hospital [4] 2279 0
Box Hill Hospital - Box Hill
Recruitment hospital [5] 2280 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 2281 0
Gosford Hospital - Gosford
Recruitment hospital [7] 4783 0
The Alfred - Prahran
Recruitment hospital [8] 4784 0
Keogh Institute for Medical Research - Nedlands
Recruitment hospital [9] 4785 0
Oztrials Clinical Research - Drummoyne
Recruitment postcode(s) [1] 7387 0
2305 - New Lambton
Recruitment postcode(s) [2] 7389 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 7390 0
3181 - Prahran
Recruitment postcode(s) [4] 7954 0
2747 - Kingswood
Recruitment postcode(s) [5] 7955 0
3128 - Box Hill
Recruitment postcode(s) [6] 7956 0
5000 - Adelaide
Recruitment postcode(s) [7] 7957 0
2031 - Randwick
Recruitment postcode(s) [8] 7958 0
2250 - Gosford
Recruitment postcode(s) [9] 12302 0
2047 - Drummoyne
Recruitment postcode(s) [10] 12303 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 5944 0
New Zealand
State/province [1] 5944 0
Auckland; Dunedin; Hawkes Bay

Funding & Sponsors
Funding source category [1] 288049 0
Commercial sector/Industry
Name [1] 288049 0
Vital Food Processors Ltd
Country [1] 288049 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Vital Food Processors Ltd
Address
78 Ascot Road
Airport Oaks Auckland 2022
Country
New Zealand
Secondary sponsor category [1] 286774 0
None
Name [1] 286774 0
Address [1] 286774 0
Country [1] 286774 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289975 0
Hunter New England Local HREC (EC00403)
Ethics committee address [1] 289975 0
Ethics committee country [1] 289975 0
Australia
Date submitted for ethics approval [1] 289975 0
30/09/2013
Approval date [1] 289975 0
04/11/2013
Ethics approval number [1] 289975 0
HREC/13/HNE/402

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

Contacts
Principal investigator
Name 43002 0
Prof Peter Gibson
Address 43002 0
Alfred Hospital, Dept. of Gastroenterology
55 Commercial Road
3004 Melbourne, Victoria
Country 43002 0
Australia
Phone 43002 0
+61 3 9076 2223
Fax 43002 0
+61 3 9076 2194
Email 43002 0
Peter.gibson@med.monash.edu.au
Contact person for public queries
Name 43003 0
T. Justus Homburg
Address 43003 0
Vital Food Processors Ltd
78 Ascot Road, Airport Oaks, Auckland 2022
Country 43003 0
New Zealand
Phone 43003 0
+64 9 275 5073
Fax 43003 0
+64 9 275 5576
Email 43003 0
justus.homburg@vitalfoods.co.nz
Contact person for scientific queries
Name 43004 0
Iona Weir
Address 43004 0
Vital Food Processors Ltd
78 Ascot Road, Airport Oaks, Auckland 2022
Country 43004 0
New Zealand
Phone 43004 0
+64 9 275 5073
Fax 43004 0
+64 9 275 5576
Email 43004 0
iona.weir@vitalfoods.co.nz

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.