Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00279

2 Trial Registration Date

2010-12-22

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Departmental research funding

5 Primary Sponsor

Urology Division, Department of Surgery, CUHK

6 Secondary Sponsor

Nil

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Lee, Wai Man

ii Address

4/F, Department of Surgery, Clinical Science Building, PWH

iii Phone

26321663

iv Email

kimlwm@surgery.cuhk.edu.hk

v Affiliation

Urology Division, Department of Surgery, CUHK

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Ng, Chi Fai

ii Address

4/F, Department of Surgery, Clinical Science Building, PWH

iii Phone

26322625

iv Email

ngcf@surgery.cuhk.edu.hk

v Affiliation

Urology Division, Department of Surgery, CUHK

vi Country

9 Official Scientific Title of the Study

A prospective randomized double-blinded placebo controlled study on the effects of adjuvant tamsulosin OCAS in the treatment outcome of patient receiving extracorporeal shock wave lithotripsy for renal calculi

10 Public Title

A prospective randomized double-blinded placebo controlled study on the effects of adjuvant tamsulosin OCAS in the treatment outcome of patient receiving extracorporeal shock wave lithotripsy for renal calculi

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Tamsulosin After Lithotripsy to Kidney stone (TALK) trial

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2010-09-07

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Renal Stone

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Tamsulosin OCAS

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

12 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

• Adult patient (aged ≥ 18 years old).
• Solitary radio-opaque renal stones of size 5-15 mm in maximal diameter as measured from plain radiography
• Clinically decided for primary ESWL

ii Exclusion Criteria

• Stones associated with any renal or ureteric anatomical abnormality, such as caliceal diverticulum, horseshoe kidney, ureteropelvic junction obstruction etc
• Patients with ureteric stent or nephrostomy tube inserted
• Patients with known history of cystine stone.
• Patients with multiple stones in the same calix
• Patient with history of allergy or any abnormal reaction alfentanil

iii Age Minimum

18

iv Age Maximum

Nil

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2011-02-01

21 Target Sample Size

220

22 Recruitment Status

Unknown

23 Primary Outcome

Successful treatment - Defined as either stone free or presence of clinically insignificant residual fragments (less than 4mm) at 12 weeks after one session of lithotripsy.

24 Secondary Outcome

Analgesics demand after treatment, maximal pain occurred after SWL, time to stone passage, stone free rate

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-07-06

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-10001135

28 Date of Registration in Primary Registry

2011-01-01

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2015-05-10