Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000555954
Ethics application status
Approved
Date submitted
30/05/2011
Date registered
1/06/2011
Date last updated
7/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of Silodosin in Expulsive Therapy of Lower Ureteral Stones: A Randomized Controlled trial
Scientific title
Efficacy of silodosin in expulsive therapy of lower ureteral stones
Secondary ID [1] 262271 0
Nil
Universal Trial Number (UTN)
U1111-1121-8109
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lower ureteral stones 267973 0
Condition category
Condition code
Renal and Urogenital 268104 268104 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
silodosin (4 mg daily) orally for 2 weeks
Intervention code [1] 266662 0
Treatment: Drugs
Comparator / control treatment
lactose tablet orally daily for 2 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 266853 0
the expulsion time
Timepoint [1] 266853 0
reported by patient within 2 weeks or Stone presence and characteristics were diagnosed through x-ray of kidney-ureter-bladder, abdominal ultrasonography, intravenous urography and nonenhenced CT 2 weeks later
Primary outcome [2] 266860 0
the expulsion rate
Timepoint [2] 266860 0
Stone presence and characteristics were diagnosed through x-ray of kidney-ureter-bladder, abdominal ultrasonography, intravenous urography and nonenhenced CT 2 weeks later
Secondary outcome [1] 276503 0
analgesic consumption
Timepoint [1] 276503 0
(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) recorded by patient diaries in2 weeks
Secondary outcome [2] 276513 0
lower urinar tract symptoms
Timepoint [2] 276513 0
Questionrire (IPSS) 2 weeks later
Secondary outcome [3] 276539 0
colic episodes
Timepoint [3] 276539 0
recorded by patient diaries in 2 weeks

Eligibility
Key inclusion criteria
patients with radiopaque lower ureteral stones>5mm
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

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 number 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
Completed
Date of first participant enrolment
Anticipated
1/05/2010
Actual
1/05/2010
Date of last participant enrolment
Anticipated
31/12/2011
Actual
31/12/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
55
Accrual to date
Final
Recruitment outside Australia
Country [1] 3603 0
Taiwan, Province Of China
State/province [1] 3603 0

Funding & Sponsors
Funding source category [1] 267153 0
Self funded/Unfunded
Name [1] 267153 0
Chung Jing Wang
Country [1] 267153 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Chung Jing Wang
Address
60058 No 565 2nd Ta-Ya Rd Chia-Yi city, Taiwan,ROC
St. Martin De Porres Hospital
Country
Taiwan, Province Of China
Secondary sponsor category [1] 266226 0
None
Name [1] 266226 0
Address [1] 266226 0
Country [1] 266226 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269144 0
STM IRB
Ethics committee address [1] 269144 0
60058 No 565 2nd Ta-Ya Rd Chia-Yi city Taiwan,ROC
St. Martin De Porres Hospital
Ethics committee country [1] 269144 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 269144 0
11/03/2010
Approval date [1] 269144 0
15/04/2010
Ethics approval number [1] 269144 0
IRB-STM-2010-012

Summary
Brief summary
perform a comparative study to evaluate the clinical role of silodosin in the medical expulsive therapy of symptomatic lower ureteral stones.
Trial website
Trial related presentations / publications
not yet
Public notes

Contacts
Principal investigator
Name 32670 0
A/Prof Chung Jing Wang
Address 32670 0
60058 No 565 2nd Ta-Ya Rd Chia-Yi city, Taiwan,ROC
St. Martin De Porres Hospital
Country 32670 0
Taiwan, Province Of China
Phone 32670 0
886-5-2756000-1013
Fax 32670 0
886-5-2788535
Email 32670 0
[email protected]
Contact person for public queries
Name 15917 0
A/Prof Chung Jing Wang
Address 15917 0
60058 No 565 2nd Ta-Ya Rd Chia-Yi city, Taiwan,ROC
St. Martin De Porres Hospital
Country 15917 0
Taiwan, Province Of China
Phone 15917 0
886-5-2756000-1013
Fax 15917 0
886-5-2788535
Email 15917 0
[email protected]
Contact person for scientific queries
Name 6845 0
A/Prof Chung Jing Wang
Address 6845 0
60058 No 565 2nd Ta-Ya Rd Chia-Yi city, Taiwan,ROC
St. Martin De Porres Hospital
Country 6845 0
Taiwan, Province Of China
Phone 6845 0
886-5-2756000-1013
Fax 6845 0
886-5-2788535
Email 6845 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.