Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00117

2 Trial Registration Date

2006-10-14

i Registration Status

Prospective

3 Secondary IDs

N.A.

4 Source(s) of Funding

Department of Obstetrics & Gynaecology

5 Primary Sponsor

N.A.

6 Secondary Sponsor

N.A.

Function

Please specify

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

i Name

Dr. CHAN, Symphorosa Shing Chee

ii Address

1E, Department of O&G, Prince of Wales Hospital, Shatin, N.T., Hong Kong

iii Phone

852 2632 2814

iv Email

symphorosa@cuhk.edu.hk

v Affiliation

Associate Consultant

vi Country

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

i Name

Dr. CHAN, Symphorosa Shing Chee

ii Address

1E, Department of O&G, Prince of Wales Hospital, Shatin, N.T., Hong Kong

iii Phone

852 2632 2814

iv Email

symphorosa@cuhk.edu.hk

v Affiliation

Associate Consultant

vi Country

9 Official Scientific Title of the Study

A Randomized, Double-blind, Placebo-controlled Study on Treatment of Nocturia with Desmopressin in Women

10 Public Title

A Randomized, Double-blind, Placebo-controlled Study on Treatment of Nocturia with Desmopressin in Women

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

N.A.

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?

2006-04-24

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Nocturia

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

MINIRIN 0.2 mg tablets containing desmopressin acetate 0.2 mg and excipients q.s. (oral; 1 dose per night for 3 weeks)

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Patients will experience 1-week screening period and 3-week double-blind period.

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo (oral; 1 dose per night for 3 weeks)

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

All female patients attending the Urodynamic Clinic at Prince of Wales Hospital and Queen Elizabeth Hospital with nocturia problems.

ii Exclusion Criteria

(1) known alcoholics or drug abusers; (2) pregnant or breast-feeding women; (3) suspicion or evidence of clinically relevant cardiac failure; (4) any history of clinically significant hepatic or renal diseases; (5) any history of uncontrolled hypertension; (6) abnormal level of serum potassium and/or serum creatinine; (7) serum sodium level below normal range; (8) treatment within 30 days of study start with drug or medication known or suspected to interact with desmopressin; (9) hypersensitivity to desmopressin; (10) multiple sclerosis; (11) consistent residual volume >150 ml, as assessed by palpation; (12) shift-workers; (13) diagnosed or suspected diabetes insipidus or primary polydipsia (urine output >40 ml/kg body weight per 24 hours); (14) clinically significant haematuria, bacteriuria, polyuria, proteinuria, glucosuria or ketouria; (15) previous inclusion in this study or other studies of desmopressin; (16) other investigational drugs or medication taken in the past 30 days; (17) patients scheduled for in-patient surgery during this trial; (18) any history of clinically relevant psychiatric disorders within the last 24 months proceeding enrolment in this trial; (19) any history of non-compliance to medical regimens or not compliant with protocol requirements; (20) unable to keep a diary or perform volume measurements on their own

iii Age Minimum

18

iv Age Maximum

65

v Gender

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

2006-11-28

21 Target Sample Size

50/50

22 Recruitment Status

Recruiting

23 Primary Outcome

Clinical efficacy of oral desmopressin in the treatment of nocturia in women and the effect of desmopressin on the study population with regards to quality of life and safety will be examinated and documented.

24 Secondary Outcome

N.A.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-03-02

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000690

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N.A.

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Trial History Detail on 2011-02-08