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

Primary Purpose

Nocturia

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
A: Desmopressin 25 µg
B. Desmopressin 50 µg
Placebo
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Clinic Tsudanuma
  • University of Fukui Hospital
  • Kato Clinic
  • Umeyama Clinic
  • Harada Urology Clinic
  • Sakaguchi Urological Clinic
  • Nakamura Urology Clinic
  • Nishi-Yokohama International Hospital
  • Yokohama Shinmidori General Hospital
  • Izumino Hospital, Bouchikai
  • Kamei Clinic
  • Den Urology Clinic
  • Iwasa Clinic
  • Kanno Clinic
  • Morimoto Clinic
  • Naka Clinic
  • Uemura Clinic
  • Urology department Kuroda Clinic
  • Yamaguchi Clinic
  • Yamanaka Clinic
  • Fukuda Clinic
  • Yasuda Urology Clinic
  • Hirano Clinic
  • Hirata Internal Medicine Urology Clinic
  • J Tower Clinic
  • Koganeibashi Sakura Clinic
  • Kunitachi Sakura Hospital
  • Kusunoki Clinic
  • Moriguchi Clinic
  • Nakanoma Clinic Urology Department
  • Ogawa Clinic
  • Ogikubo Ekimae Clinic
  • Shibuya Shin-minamiguchi Clinic
  • Tokyo Kamata Hospital
  • Toru Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

A. Desmopressin 25 µg

B. Desmopressin 50 µg

C. Placebo

Arm Description

1 orally disintegrating tablet every night during study period

1 orally disintegrating tablet every night during study period

1 orally disintegrating tablet every night during study period

Outcomes

Primary Outcome Measures

Change from baseline in mean number of nocturnal voids

Secondary Outcome Measures

Change from baseline in mean time to first void
Responder status (33% reduction in nocturnal voids)
Change from baseline in mean number of nocturnal voids
Change from baseline in mean time to first void
Responder status (33% reduction in nocturnal voids)
Change from baseline in mean nocturnal urine volume
Change from baseline in nocturnal polyuria index
Change from baseline in the effect on sleep disturbance
Change from baseline in the impact on quality of life
Adverse events, changes from baseline in serum sodium level, laboratory values

Full Information

First Posted
September 11, 2012
Last Updated
August 22, 2013
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01694498
Brief Title
Comparative Trial to Investigate the Efficacy and Safety of Desmopressin for the Treatment of Nocturia in Adult Men
Acronym
NOC
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 men during 12 weeks treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A. Desmopressin 25 µg
Arm Type
Active Comparator
Arm Description
1 orally disintegrating tablet every night during study period
Arm Title
B. Desmopressin 50 µg
Arm Type
Active Comparator
Arm Description
1 orally disintegrating tablet every night during study period
Arm Title
C. Placebo
Arm Type
Placebo Comparator
Arm Description
1 orally disintegrating tablet every night during study period
Intervention Type
Drug
Intervention Name(s)
A: Desmopressin 25 µg
Intervention Type
Drug
Intervention Name(s)
B. Desmopressin 50 µg
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in mean number of nocturnal voids
Time Frame
During 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in mean time to first void
Time Frame
During 12 weeks
Title
Responder status (33% reduction in nocturnal voids)
Time Frame
During 12 weeks
Title
Change from baseline in mean number of nocturnal voids
Time Frame
1, 4, 8 and 12 weeks
Title
Change from baseline in mean time to first void
Time Frame
1, 4, 8 and 12 weeks
Title
Responder status (33% reduction in nocturnal voids)
Time Frame
1, 4, 8 and 12 weeks
Title
Change from baseline in mean nocturnal urine volume
Time Frame
1, 4, 8 and 12 weeks
Title
Change from baseline in nocturnal polyuria index
Time Frame
1, 4, 8 and 12 weeks
Title
Change from baseline in the effect on sleep disturbance
Time Frame
1, 4, 8 and 12 weeks
Title
Change from baseline in the impact on quality of life
Time Frame
12 weeks
Title
Adverse events, changes from baseline in serum sodium level, laboratory values
Time Frame
During 12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Clinic Tsudanuma
City
Chiba
Country
Japan
Facility Name
University of Fukui Hospital
City
Fukui
Country
Japan
Facility Name
Kato Clinic
City
Gunma
Country
Japan
Facility Name
Umeyama Clinic
City
Gunma
Country
Japan
Facility Name
Harada Urology Clinic
City
Hyogo
Country
Japan
Facility Name
Sakaguchi Urological Clinic
City
Hyogo
Country
Japan
Facility Name
Nakamura Urology Clinic
City
Kanagawa
Country
Japan
Facility Name
Nishi-Yokohama International Hospital
City
Kanagawa
Country
Japan
Facility Name
Yokohama Shinmidori General Hospital
City
Kanagawa
Country
Japan
Facility Name
Izumino Hospital, Bouchikai
City
Kochi
Country
Japan
Facility Name
Kamei Clinic
City
Kochi
Country
Japan
Facility Name
Den Urology Clinic
City
Osaka
Country
Japan
Facility Name
Iwasa Clinic
City
Osaka
Country
Japan
Facility Name
Kanno Clinic
City
Osaka
Country
Japan
Facility Name
Morimoto Clinic
City
Osaka
Country
Japan
Facility Name
Naka Clinic
City
Osaka
Country
Japan
Facility Name
Uemura Clinic
City
Osaka
Country
Japan
Facility Name
Urology department Kuroda Clinic
City
Osaka
Country
Japan
Facility Name
Yamaguchi Clinic
City
Osaka
Country
Japan
Facility Name
Yamanaka Clinic
City
Osaka
Country
Japan
Facility Name
Fukuda Clinic
City
Saitama
Country
Japan
Facility Name
Yasuda Urology Clinic
City
Saitama
Country
Japan
Facility Name
Hirano Clinic
City
Tokyo
Country
Japan
Facility Name
Hirata Internal Medicine Urology Clinic
City
Tokyo
Country
Japan
Facility Name
J Tower Clinic
City
Tokyo
Country
Japan
Facility Name
Koganeibashi Sakura Clinic
City
Tokyo
Country
Japan
Facility Name
Kunitachi Sakura Hospital
City
Tokyo
Country
Japan
Facility Name
Kusunoki Clinic
City
Tokyo
Country
Japan
Facility Name
Moriguchi Clinic
City
Tokyo
Country
Japan
Facility Name
Nakanoma Clinic Urology Department
City
Tokyo
Country
Japan
Facility Name
Ogawa Clinic
City
Tokyo
Country
Japan
Facility Name
Ogikubo Ekimae Clinic
City
Tokyo
Country
Japan
Facility Name
Shibuya Shin-minamiguchi Clinic
City
Tokyo
Country
Japan
Facility Name
Tokyo Kamata Hospital
City
Tokyo
Country
Japan
Facility Name
Toru Clinic
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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