Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01684800
Other study ID # 000029
Secondary ID
Status Completed
Phase Phase 2
First received September 11, 2012
Last updated August 22, 2013
Start date September 2012
Est. completion date June 2013

Study information

Verified date August 2013
Source Ferring Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial Summary

The purpose of the study is to investigate the efficacy and safety of two different dose levels of desmopressin orally disintegrating tablets against placebo for the treatment of nocturia in adult women during 12 weeks treatment


Recruitment information / eligibility

Status Completed
Enrollment 178
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Has given written consent prior to any trial-related activity is performed.

- Female sex, aged 20 years or older.

- At least 2 nocturnal voids every night in a consecutive 3-day period as documented in the diary during the screening period.

- Has given agreement about contraception during the trial.

Exclusion Criteria:

- Showing symptoms of any of the following diseases: Interstitial cystitis; Overactive bladder, defined as >6 daytime voids,=1 urgency episode and =1 urge urinary incontinence episode per 24 hours as documented in the 3-day diary period; Severe stress urinary incontinence.

- Psychogenic or habitual polydipsia.

- Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention.

- Cancer.

- A history of urologic malignancies or a history of cancer which has not been in remission for the last 5 years.

- Genito-urinary tract pathology.

- Neurogenic detrusor activity.

- Suspicion or evidence of heart failure.

- Uncontrolled hypertension.

- Uncontrolled diabetes mellitus.

- Hepatobiliary diseases: Aspartate aminotransferase >80 U/L or alanine aminotransferase >90 U/L; Total bilirubin >1.5 mg/dL.

- Renal insufficiency: Serum creatinine level >0.82 mg/dL; Estimated glomerular filtration rate <50 mL/min.

- Hyponatraemia: Serum sodium level <135 mEq/L.

- Central or nephrogenic diabetes insipidus.

- Syndrome of inappropriate antidiuretic hormone.

- Obstructive sleep apnea.

- Previous desmopressin treatment.

- Treatment with another investigational product within the past 3 months.

- Concomitant treatment with any prohibited medication.

- Pregnancy, breastfeeding, or a plan to become pregnant during the period of the clinical trial.

- Alcohol or substance abuse.

- A job or lifestyle that may interfere with regular night-time sleep.

- A mental condition, lack of decision-making ability, dementia, a speech handicap, or any other reason which, in the judgement of the investigator (sub-investigator), would impair the participation in the trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
A. Desmopressin 10 microgram
1 orally disintegrating tablet every night during study period
B: Desmopressin 25 microgram
1 orally disintegrating tablet every night during study period
C: Placebo
1 orally disintegrating tablet every night during study period

Locations

Country Name City State
Japan Japanese Red Cross Nagoya Daiichi Hospital Aichi
Japan Clinic Tsudanuma Chiba
Japan University of Fukui Hospital Fukui
Japan Kato Clinic Gunma
Japan Umeyama Clinic Gunma
Japan Harada Urology Clinic Hyogo
Japan Sakaguchi Urological Clinic Hyogo
Japan Nakamura Urology Clinic Kanagawa
Japan Nishi-Yokohama International Hospital Kanagawa
Japan Yokohama Shinmidori General Hospital Kanagawa
Japan Izumino Hospital, Bouchikai Kochi
Japan Kamei Clinic Kochi
Japan Den Urology Clinic Osaka
Japan Iwasa Clinic Osaka
Japan Kanno Clinic Osaka
Japan Morimoto Clinic Osaka
Japan Naka Clinic Osaka
Japan Uemura Clinic Osaka
Japan Urology department Kuroda Clinic Osaka
Japan Yamaguchi Clinic Osaka
Japan Yamanaka Clinic Osaka
Japan Fukuda Clinic Saitama
Japan Yasuda Urology Clinic Saitama
Japan Hirano Clinic Tokyo
Japan Hirata Internal Medicine Urology Clinic Tokyo
Japan J Tower Clinic Tokyo
Japan Koganeibashi Sakura Clinic Tokyo
Japan Kunitachi Sakura Hospital Tokyo
Japan Kusunoki Clinic Tokyo
Japan Moriguchi Clinic Tokyo
Japan Nakanoma Clinic Urology Department Tokyo
Japan Ogawa Clinic Tokyo
Japan Ogikubo Ekimae Clinic Tokyo
Japan Shibuya Shin-minamiguchi Clinic Tokyo
Japan Tokyo Kamata Hospital Tokyo
Japan Toru Clinic Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in mean number of nocturnal voids During 12 weeks No
Secondary Change from baseline in mean time to first void During 12 weeks No
Secondary Responder status (33% reduction in nocturnal voids) During 12 weeks No
Secondary Change from baseline in mean number of nocturnal voids 1, 4, 8 and 12 weeks No
Secondary Change from baseline in mean time to first void 1, 4, 8 and 12 weeks No
Secondary Responder status (33% reduction in nocturnal voids) 1, 4, 8 and 12 weeks No
Secondary Change from baseline in mean nocturnal urine volume 1, 4, 8 and 12 weeks No
Secondary Change from baseline in nocturnal polyuria index 1, 4, 8 and 12 weeks No
Secondary Change from baseline in the effect on sleep disturbance 1, 4, 8 and 12 weeks No
Secondary Change from baseline in the impact on quality of life 12 weeks No
Secondary Adverse events, changes from baseline in serum sodium level, laboratory values During 12 weeks Yes
See also
  Status Clinical Trial Phase
Completed NCT03623880 - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders N/A
Completed NCT02835846 - Investigation of the Effect of the Female Urinary Microbiome on Incontinence Phase 4
Completed NCT02905682 - Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Female Subjects Phase 3
Completed NCT02904759 - Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Male Subjects Phase 3
Completed NCT01694498 - Comparative Trial to Investigate the Efficacy and Safety of Desmopressin for the Treatment of Nocturia in Adult Men Phase 2
Completed NCT01520948 - Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease Phase 3
Completed NCT01222598 - A Study of Minirin Melt in Patients With Nocturia N/A
Recruiting NCT04305743 - Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A Phase 4
Completed NCT01486706 - Efficacy and Safety of Gabapentin in Treating Overactive Bladder Phase 2/Phase 3
Completed NCT04528784 - Feasibility Study of Transcutaneous Tibial Nerve Stimulation for Urinary Symptoms in People With Multiple Sclerosis N/A
Recruiting NCT05874375 - UCon Treatment of Overactive Bladder (OAB) in Males N/A
Completed NCT01223937 - Investigation of the Superiority Effect of Desmopressin to Placebo in Terms of Night Voids Reduction in Nocturia Adult Female Patients Phase 3
Withdrawn NCT01018225 - Exploratory Study Evaluating the Effects of Darifenacin on Nocturia, Sleep and Daytime Wakefulness Phase 4
Completed NCT05222477 - Abdominal Muscle Exercises on Nocturia and Sleep Quality in Women With Type 2 Diabetes N/A
Withdrawn NCT02961114 - Use of Autologous Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Symptomatic Benign Prostate Hypertrophy Phase 1/Phase 2
Completed NCT02440841 - Study in Healthy Male Subjects to Evaluate the Effect of Itraconazole and Rifampicin on the PK of Fedovapagon Phase 1
Completed NCT02068560 - The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion N/A
Completed NCT01357356 - Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia Phase 2/Phase 3
Completed NCT02151253 - Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia Phase 2/Phase 3
Completed NCT00700583 - Alpha-blocker Plus Diuretic Combination Therapy as Second-line Treatment for Nocturia in Men N/A