Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000623099
Ethics application status
Approved
Date submitted
22/07/2010
Date registered
29/07/2010
Date last updated
27/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Distal Ureteric Stones and Tamsulosin - the D.U.S.T. trial
Scientific title
Tamsulosin for the treatment of Distal Ureteric Calculi: A Double-Blinded, Placebo-Controlled, Randomised, Multi-Centre Trial (The DUST Trial)
Secondary ID [1] 252270 0
Nil
Universal Trial Number (UTN)
U1111-1116-1717
Trial acronym
The D.U.S.T. Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distal Ureteric calculi 257791 0
Condition category
Condition code
Renal and Urogenital 257963 257963 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will recieve Tamsulosin 0.4mg orally, daily for 28 days (Standard care will include analgesia with Indomethicin 25-50mg orally three times a day or 100mg suppository twice a day AND Oxycodone 5-10mg orally three times a day as needed)
Intervention code [1] 256857 0
Treatment: Drugs
Comparator / control treatment
The control group will recieve Placebo, one tablet orally, daily for 28 days. (Standard care will include analgesia with Indomethicin 25-50mg orally three times a day or 100mg suppository twice a day AND Oxycodone 5-10mg orally three times a day as needed)
Control group
Placebo

Outcomes
Primary outcome [1] 258830 0
Stone expulsion (assessed by repeat Computed Tomography)
Timepoint [1] 258830 0
28 days after enrolment
Primary outcome [2] 258831 0
Time to stone expulsion (as reported by participants)
Timepoint [2] 258831 0
Up to 28 days (participants will be asked to maintain a diary, and contacted by phone weekly for a structured interview, and in person at 28 days after enrolment)
Secondary outcome [1] 264936 0
Un-planned representation to the Emergency Department and/or Hospital admission (as reported by patients at structured interviews and cross checked with participating hospital databases).
Timepoint [1] 264936 0
28 days from enrolment
Secondary outcome [2] 264937 0
Analgesia requirements (total doses of Indomethicin and Oxycodone) - as recorded in paticipant diaries and reported by participants at structured interviews
Timepoint [2] 264937 0
28 days from enrolment
Secondary outcome [3] 264938 0
Pain scores (measured on a verbal numeric pain scale recorded in patient diaries highest per 24 hr period) as recorded in paticipant diaries and reported by participants at structured interviews
Timepoint [3] 264938 0
28 days from enrolment
Secondary outcome [4] 264939 0
Urological interventions required for any reason (as reported by patients at structured interviews and cross checked with participating hospital databases)
Timepoint [4] 264939 0
28 days from enrolment
Secondary outcome [5] 264940 0
Rates of complications (i.e. Infection by positive culture of pathogenic bacteria in blood or urine, and renal impairment as defined by decrease in Glomerular Filtration Rate of > 20 ml/min/1.73m2)
Timepoint [5] 264940 0
28 days from enrolment
Secondary outcome [6] 264941 0
Days off work (recorded in patient diary)
Timepoint [6] 264941 0
28 days from enrolment
Secondary outcome [7] 264942 0
Reported adverse effects from study drugs (monitored weekly in structured interview e.g. dizziness, palpitations, tachycardia, hypotension, orthostatic hypotension, syncope, depressed level of consciousness, abnormal ejaculation, headache, asthenia, fatigue, somnolence, rhinitis and nasal congestion)
Timepoint [7] 264942 0
28 days from enrolment

Eligibility
Key inclusion criteria
Radiologically documented calculus in the distal ureter, less than or equal to 10mm diameter and no exclusion criteria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Paediatric Patients <18 years, Infection (fever > 38 degrees), Glomerular Filtration Rate < 60 ml/min/1.73m2, Calculus >1cm diameter, Solitary kidney, Transplanted kidney, History of ureteral stricture, Pregnancy or planning pregnancy, Allergic reaction to the study medication, Current calcium channel blocker or a1-blocker use, Hypotension (Systolic Blood Pressure < 100 mmHg)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Stratified by stone size (0-5mm and >5mm)
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/08/2010
Actual
29/08/2010
Date of last participant enrolment
Anticipated
Actual
7/03/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3848 0
The Townsville Hospital - Douglas
Recruitment hospital [2] 3849 0
Gold Coast Hospital - Southport
Recruitment hospital [3] 3850 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [4] 3851 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 9733 0
4814 - Aitkenvale

Funding & Sponsors
Funding source category [1] 257315 0
Charities/Societies/Foundations
Name [1] 257315 0
Queensland Emergency Medicine Research Foundation (QEMRF)
Country [1] 257315 0
Australia
Primary sponsor type
Hospital
Name
The Townsville Hospital
Address
100 Angus Smith Drive
Douglas, Townsville QLD
4814
Country
Australia
Secondary sponsor category [1] 256560 0
None
Name [1] 256560 0
Address [1] 256560 0
Country [1] 256560 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259344 0
Townsville health service district - Human Research Ethics Committee
Ethics committee address [1] 259344 0
100 Angus Smith Dirve
Douglas, Townsville 4814
Queensland
Ethics committee country [1] 259344 0
Australia
Date submitted for ethics approval [1] 259344 0
Approval date [1] 259344 0
17/11/2009
Ethics approval number [1] 259344 0
HREC/09/QTHS/105
Ethics committee name [2] 259345 0
Royal Brisbane and Womens Hospital - Metro north Health Service District Human Research Ethics Committee
Ethics committee address [2] 259345 0
Butterfield St, Herston
QLD 4029
Ethics committee country [2] 259345 0
Australia
Date submitted for ethics approval [2] 259345 0
Approval date [2] 259345 0
24/03/2010
Ethics approval number [2] 259345 0
HREC/10/QRBW/105

Summary
Brief summary
Ureteric colic (or Kidney stones) is a significant public health concern within Australia, affecting as many as 5-15% of adults. As a result, a significant number of Australians experience significant pain, hospital and outpatient visits, and the potential for more significant complications such as infection, kidney damage and the need for surgical treatments.
Although several methods of medical treatments to improve care of such patients have been studied overseas, some of which appear promising, the practice of “medical expulsive therapy” for ureteric colic is not widely practiced in Australia. One such medication is Tamsulosin, which seems to have an effect on the ureter (tube from kidney to bladder) and helps stones pass. It is already in use for other urological conditions already in Australia, and studies overseas seem to show benefit for patients with Ureteric colic.
Within Queensland Health there is substantial variation with regard to access to specialist urologist services. Benefits of medical therapies for ureteric colic may be even greater in geographically isolated areas without full time urology services.
This study aims to determine if the addition of the drug Tamsulosin 0.4mg daily, in addition to usual standard care, will improve the rates of spontaneously passing stones less than 10mm in diameter, whether the drug has any effect on pain experienced by the patients, their need for surgery and complications.
Patients who present to the participating emergency departments with Ureteric calculi, that fit the inclusion criteria will be randomly allocated to either the study medication (Tamsulosin 0.4mg daily) or placebo. The patients will then be closely monitored for four weeks, to determine if the stones pass spontaneously, or if any complications occur. At four weeks the study will be complete, patients who are yet to have passed the stone, would be referred to Urology for consideration of a procedure.
Trial website
Trial related presentations / publications
Pending
Public notes

Contacts
Principal investigator
Name 31421 0
A/Prof Jeremy Furyk
Address 31421 0
c/o the Townsville Hospital
Angus Smith Drive
Douglas Qld 4814
Country 31421 0
Australia
Phone 31421 0
+61 7 4433 1111
Fax 31421 0
Email 31421 0
[email protected]
Contact person for public queries
Name 14668 0
Jeremy Furyk
Address 14668 0
c/o The Townsville Hospital
Emergency Department
100 Angus Smith Drive
Douglas QLD 4814
Country 14668 0
Australia
Phone 14668 0
+61 7 4796 1111
Fax 14668 0
+61 7 4796 2901
Email 14668 0
[email protected]
Contact person for scientific queries
Name 5596 0
Jeremy Furyk
Address 5596 0
c/o The Townsville Hospital
Emergency Department
100 Angus Smith Drive
Douglas QLD 4814
Country 5596 0
Australia
Phone 5596 0
+61 7 4796 1111
Fax 5596 0
+61 7 4796 2901
Email 5596 0
[email protected]

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No Supporting Document Provided



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