Comparative Trial to Investigate the Efficacy and Safety of Desmopressin for the Treatment of Nocturia in Adult Men (NOC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01694498
First received: September 11, 2012
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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 men during 12 weeks treatment


Condition Intervention Phase
Nocturia
Drug: A: Desmopressin 25 µg
Drug: B. Desmopressin 50 µg
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial Investigating the Efficacy and Safety of Two Different Dose Levels of Desmopressin for the Treatment of Nocturia in Adult Men

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in mean number of nocturnal voids [ Time Frame: During 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in mean time to first void [ Time Frame: During 12 weeks ] [ Designated as safety issue: No ]
  • Responder status (33% reduction in nocturnal voids) [ Time Frame: During 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of nocturnal voids [ Time Frame: 1, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean time to first void [ Time Frame: 1, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Responder status (33% reduction in nocturnal voids) [ Time Frame: 1, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean nocturnal urine volume [ Time Frame: 1, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in nocturnal polyuria index [ Time Frame: 1, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the effect on sleep disturbance [ Time Frame: 1, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the impact on quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Adverse events, changes from baseline in serum sodium level, laboratory values [ Time Frame: During 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 183
Study Start Date: September 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A. Desmopressin 25 µg
1 orally disintegrating tablet every night during study period
Drug: A: Desmopressin 25 µg
Active Comparator: B. Desmopressin 50 µg
1 orally disintegrating tablet every night during study period
Drug: B. Desmopressin 50 µg
Placebo Comparator: C. Placebo
1 orally disintegrating tablet every night during study period
Drug: Placebo

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has given written consent prior to any trial-related activity is performed
  • Male 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:

  • Suspicion of bladder outlet obstruction or a urine flow of less than 5 mL/s as confirmed by uroflowmetry after suspicion of bladder outlet obstruction
  • A surgical treatment for bladder outlet obstruction or prostatic hyperplasia within the past 6 months
  • Showing symptoms of any of the following diseases: Benign prostatic obstruction; 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
  • Chronic prostatitis/chronic pelvic pain syndrome
  • 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 >1.09 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694498

Locations
Japan
Clinic Tsudanuma
Chiba, Japan
University of Fukui Hospital
Fukui, Japan
Kato Clinic
Gunma, Japan
Umeyama Clinic
Gunma, Japan
Sakaguchi Urological Clinic
Hyogo, Japan
Harada Urology Clinic
Hyogo, Japan
Nakamura Urology Clinic
Kanagawa, Japan
Nishi-Yokohama International Hospital
Kanagawa, Japan
Yokohama Shinmidori General Hospital
Kanagawa, Japan
Kamei Clinic
Kochi, Japan
Izumino Hospital, Bouchikai
Kochi, Japan
Den Urology Clinic
Osaka, Japan
Yamaguchi Clinic
Osaka, Japan
Urology department Kuroda Clinic
Osaka, Japan
Uemura Clinic
Osaka, Japan
Iwasa Clinic
Osaka, Japan
Morimoto Clinic
Osaka, Japan
Naka Clinic
Osaka, Japan
Yamanaka Clinic
Osaka, Japan
Kanno Clinic
Osaka, Japan
Yasuda Urology Clinic
Saitama, Japan
Fukuda Clinic
Saitama, Japan
J Tower Clinic
Tokyo, Japan
Ogawa Clinic
Tokyo, Japan
Shibuya Shin-minamiguchi Clinic
Tokyo, Japan
Tokyo Kamata Hospital
Tokyo, Japan
Toru Clinic
Tokyo, Japan
Nakanoma Clinic Urology Department
Tokyo, Japan
Moriguchi Clinic
Tokyo, Japan
Kusunoki Clinic
Tokyo, Japan
Kunitachi Sakura Hospital
Tokyo, Japan
Koganeibashi Sakura Clinic
Tokyo, Japan
Hirata Internal Medicine Urology Clinic
Tokyo, Japan
Hirano Clinic
Tokyo, Japan
Ogikubo Ekimae Clinic
Tokyo, Japan
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01694498     History of Changes
Other Study ID Numbers: 000030
Study First Received: September 11, 2012
Last Updated: August 22, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Nocturia
Lower Urinary Tract Symptoms
Signs and Symptoms
Urological Manifestations
Deamino Arginine Vasopressin
Antidiuretic Agents
Cardiovascular Agents
Coagulants
Hematologic Agents
Hemostatics
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014