Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000571976
Ethics application status
Approved
Date submitted
1/06/2011
Date registered
3/06/2011
Date last updated
3/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of Highly Selective-a-1A-Adrenoceptor Antagonist
Silodosin in Expulsive Therapy of Lower Ureteral Stones:
A Randomized Controlled Study
Scientific title
Efficacy of highly selective-a-1A-adrenoceptor antagonist in expulsive therapy of lower ureteral stones
Secondary ID [1] 262286 0
Nil
Universal Trial Number (UTN)
U1111-1121-8479
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
radiopaque lower ureteral stones >5mm 267993 0
Condition category
Condition code
Renal and Urogenital 268123 268123 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
orally highly selective a-1A blocker(silodosin 4 mg and tamsulosin 0.2 mg) once daily for 2 weeks
Intervention code [1] 266681 0
Treatment: Drugs
Comparator / control treatment
lactose tablet orally once daily for 2 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 266873 0
expulsion time
Timepoint [1] 266873 0
reported by patient diaries or Stone presence and characteristics were diagnosed through x-ray of kidney-ureter-bladder, abdominal ultrasonography, intravenous urography and nonenhenced CT at 2 weeks.
Primary outcome [2] 266874 0
expulsion rate
Timepoint [2] 266874 0
Stone presence and characteristics were diagnosed through x-ray of kidney-ureter-bladder, abdominal ultrasonography, intravenous urography and nonenhenced CT at 2 weeks.
Secondary outcome [1] 276540 0
analgesic consumption
Timepoint [1] 276540 0
recorded by patient(All patients were prescribed ketorolac 10 mg three time per day for analgesic use and allowed to use sublingual buprenorphine 0.2 mg on demand) at 2 weeks
Secondary outcome [2] 276541 0
lower urinary tract symptoms
Timepoint [2] 276541 0
IPSS questionnaire at 2 weeks
Secondary outcome [3] 276542 0
colic episodes
Timepoint [3] 276542 0
recorded by patient diaries daily for 2 weeks
Secondary outcome [4] 276543 0
adverse effects
Timepoint [4] 276543 0
dizziness,postural hypotension by patient diaries daily for 2 weeks

Eligibility
Key inclusion criteria
symptomatic radiopaque lower ureteral stones >5mm aged between 20 and 60 years old
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with urinary tract infections, high-grade hydronephrosis, diabetes, ulcers, or a history of hypersensitivity toa-1 blocker and pregnant women were excluded. Patients with a history of spontaneous stone expulsion, hypotension, or those found to have systolic blood pressure lower than 110 mmHg were also excluded.

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random numbers table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 3608 0
Taiwan, Province Of China
State/province [1] 3608 0

Funding & Sponsors
Funding source category [1] 267170 0
Self funded/Unfunded
Name [1] 267170 0
Chung Jing Wang
Country [1] 267170 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Chung Jing Wang
Address
600 No 565 Rd Ta-Ya Chia-Yi city, Taiwan, ROC
St Martin De Porres Hospital
Country
Taiwan, Province Of China
Secondary sponsor category [1] 266246 0
None
Name [1] 266246 0
Address [1] 266246 0
Country [1] 266246 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269165 0
IRB STM
Ethics committee address [1] 269165 0
600 No 565 Rd Ta-Ya Chia-Yi city,Taiwan ROC
St Martin De Porres Hospital
Ethics committee country [1] 269165 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 269165 0
05/06/2010
Approval date [1] 269165 0
14/07/2010
Ethics approval number [1] 269165 0

Summary
Brief summary
a comparative study to evaluate the clinical role of highly selective a-1A blocker in the medical expulsive therapy of symptomatic lower ureteral stones.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32684 0
Address 32684 0
Country 32684 0
Phone 32684 0
Fax 32684 0
Email 32684 0
Contact person for public queries
Name 15931 0
Chung Jing Wang
Address 15931 0
600 No 565 Rd Ta-Ya Chia-Yi city,Taiwan ROC
St Martin De Porres Hospital
Country 15931 0
Taiwan, Province Of China
Phone 15931 0
886-5-2756000-1013
Fax 15931 0
886-5-2788535
Email 15931 0
[email protected]
Contact person for scientific queries
Name 6859 0
Chung Jing Wang
Address 6859 0
600 No 565 Rd Ta-Ya Chia-Yi city,Taiwan ROC
St Martin De Porres Hospital
Country 6859 0
Taiwan, Province Of China
Phone 6859 0
886-5-2756000-1013
Fax 6859 0
886-5-2788535
Email 6859 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.