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Trial Detail

CUHK_CCT00117

2006-10-14

Prospective

N.A.

Department of Obstetrics & Gynaecology

N.A.

N.A.

Dr. CHAN, Symphorosa Shing Chee

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

852 2632 2814

symphorosa@cuhk.edu.hk

Associate Consultant

Dr. CHAN, Symphorosa Shing Chee

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

852 2632 2814

symphorosa@cuhk.edu.hk

Associate Consultant

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

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

N.A.

Hong Kong

Yes

2006-04-24

Nocturia

Drug

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

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

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

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

(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

18

65

Female

Interventional

Randomized

Placebo

Double-blind

Parallel

2006-11-28

50/50

Complete

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.

N.A.

No

2011-03-02

ChiCTR-TRC-09000690

2010-05-04

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