Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00152

2 Trial Registration Date

2008-04-10

i Registration Status

Retrospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Nil

5 Primary Sponsor

Division of Urology, Department of Surgery, the Chinese University of Hong Kong

6 Secondary Sponsor

NA

Function

Please specify

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

i Name

Ng Chi Fai

ii Address

Department of Surgery, 4/F, Clinical Science Building, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, NT

iii Phone

Phone: 26322625, Fax: 26377974,

iv Email

e-mail: ngcf@surgery.cuhk.edu.hk

v Affiliation

Professor, Department of Surgery

vi Country

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

i Name

Ng Chi Fai

ii Address

Department of Surgery, 4/F, Clinical Science Building, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, NT

iii Phone

Phone: 26322625, Fax: 26377974,

iv Email

e-mail: ngcf@surgery.cuhk.edu.hk

v Affiliation

Professor, Department of Surgery

vi Country

9 Official Scientific Title of the Study

Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo With Long Term Follow Up after successful Trial Without Catheter In Acute Urinary Retention

10 Public Title

Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo With Long Term Follow Up after successful Trial Without Catheter In Acute Urinary Retention

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Long term efficacy of Alfuzosin 10 mg daily in patient after successful trial without catheter

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?

2006-09-20

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Benign prostatic hyperplasia (BPH), Acute urine Retention (AUR)

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Alfuzosin GITS 10 mg

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

2 years

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

Inclusion Criteria •Aged 50 or above •Presented with first episode of AUR due to BPH with residual urine of 500 - 1500ml. •Successful TWOC after use of Alfuzosin GITS

ii Exclusion Criteria

Exclusion criteria •Previous history of TURP or other form of invasive therapy for benign prostate hyperplasia •Patient suspected or confirmed to have carcinoma of prostate •Use of alpha blockers within recent 6 months •Use of phytotherapy or 5-alpha reductase inhibitors within recent 6 months •Clot retention secondary to haematuria of any cause •Patients with depressive illness on medication, extra-pyramidal disorders, neurological disease •Patients with unstable angina, myocardial infarction, transient ischaemic attacks, cerebrovascular accident or congestive cardiac failure during the previous 6 months •Patients contraindicated for alfuzosin A.Known hypersensitivity to alfuzosin B.Orthostatic hypotension C.Hepatic insufficiency •Poor premorbid state

iii Age Minimum

>=50

iv Age Maximum

nil

v Gender

Male

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Single-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

2006-10-07

21 Target Sample Size

72

22 Recruitment Status

Complete

23 Primary Outcome

The primary objective of the study is to compare alfuzosin GITS 10 mg daily with placebo, in delaying or avoiding invasive therapy for BPH on long term follow up of Hong Kong Chinese males patients achieving a successful TWOC after AUR secondary to BPH.

24 Secondary Outcome

The secondary objective is to investigate the safety of alfuzosin GITS and also predicting factors for recurrent AUR.

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-09000719

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2011-02-08