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Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo (NOC)

Primary Purpose

Nocturia

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Desmopressin
Placebo
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturia focused on measuring nocturia, bladder function

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Given written informed consent prior to any trial-related activity is performed
  • Aged 55-75 years
  • Mean number of nocturnal voids of at least two per night
  • Reached post-menopause (applicable to females only)

Exclusion Criteria:

  • Evidence of bladder outlet obstruction (BOO); or a urine flow of less than 5 mL/s (applicable to males only)
  • A surgical treatment for BOO or prostatic hyperplasia within the past 6 months (applicable to males only)
  • Showing symptoms of any of the following diseases and having a mean number of nocturnal voids exceeding four per night: Benign prostatic hyperplasia, overactive bladder, interstitial cystitis, severe stress urinary incontinence
  • Psychosomatic or habitual polydipsia
  • Urinary retention; or a post void residual volume in excess of 150 mL
  • A history or complication of urologic malignancy (e.g. bladder cancer or prostate cancer)
  • Complication of genito-urinary pathology (e.g. infection, stone, or neoplasia)
  • Complication of neurogenic detrusor activity
  • Complication or suspicion of heart failure
  • Uncontrolled hypertension
  • Uncontrolled diabetes mellitus
  • Complication of hepatobiliary disease
  • Abnormal serum creatinine level
  • Complication of hyponatraemia, or serum sodium level <135 mEq/L
  • Central or nephrogenic diabetes insipidus (CDI or NDI)
  • Syndrome of inappropriate antidiuretic hormone (SIADH)
  • Obstructive sleep apnea
  • Alcohol dependency or drug abuse
  • A job or lifestyle that may interfere with regular night-time sleep
  • Previous desmopressin treatment
  • Treatment with another investigational product within the past 3 months
  • A need for treatment with a prohibited concomitant drug for a complication or other problem
  • A mental condition, the lack of decision-making ability, dementia or a speech handicap
  • Any other reason that the Investigator believes inappropriate

Sites / Locations

  • Japanese Red Cross Nagoya Daiichi Hospital
  • National Center for Geriatrics and Gerontology
  • Kokuho Asahi Central Hospital
  • University of Fukui Hospital
  • Takayama Hospital
  • Houshikai Group Kano Hospital
  • St. Mary's Hospital
  • Jyusendo General Hospital
  • Social Insurance Nihonmatsu Hospital
  • Takayama Clinic
  • National Hospital Organization Kobe Medical Center
  • Japanese Red Cross Mito Hospital
  • Yokohama Shin-midori General Hospital
  • Kumamoto Rosai Hospital
  • Tohoku University Hospital
  • Shinshu University Hospital
  • Senbokufujii Hospital
  • Kasukabe Chuo General Hospital
  • Hamamatsu University School of Medicine University Hospital
  • Tokyo Women's Medical University Medical Center East
  • Koganeibashi Sakura Clinic
  • Kunitachi Sakura Hospital
  • University of Yamanashi Hospital
  • Harasanshin Hospital
  • Saku Hospital
  • Southwest Urological Clinic
  • Yakuin Urogenital Hospital
  • Fukushima Red Cross Hospital
  • Ohara General Hospital
  • Saiseikai Fukushima General Hospital
  • Jigenji Kubo Clinic
  • Kawahara Hinyoukika
  • Yagi Clinic
  • Rakusai Newtown Hospital
  • Suzuki Urological Clinic
  • Nanri Urological Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Desmopressin 10µg

Desmopressin 25µg

Desmopressin 50µg

Desmopressin 100µg

Placebo

Arm Description

Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.

Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.

Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.

Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.

Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.

Outcomes

Primary Outcome Measures

Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1
Participants were water-loaded to suppress the endogenous release of vasopressin, thus all antidiuretic activity was generated by desmopressin only. Water-loading was initiated 2 hours before dosing on Day 1. Urine volume was registered and samples for osmolality check were collected every 30 minutes as long as there was an antidiuretic action defined as a urine production <0.12 mL/kg/min. The hydration should have lasted until end of action, defined as when the urine production returned to >0.12 mL/kg/min, but no longer than 12 hours.
Change From Baseline in Number of Nocturnal Voids After 28 Days of Treatment - Period 2
Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average number of nocturnal voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings.

Secondary Outcome Measures

Area Under the Urine Osmolality Curve (AUCosm)
Area under the urine osmolality curve, from dose administration to end of action (AUCosm).
Area Under the Urine Production Curve (AUCurine Prod)
Area under the urine production curve, from dose administration to end of action (AUCurine prod)
Time When Urine Production <0.12 ml/kg/Min
Urine volume was registered and samples for osmolality check were collected every 30 minutes as long as there was an antidiuretic action defined as a urine production <0.12 mL/kg/min. The hydration due to water-loading should have lasted until end of action, defined as when the urine production returned to >0.12 mL/kg/min, but no longer than 12 hours.
Change From Baseline in Duration of First Period of Undisturbed Sleep After 28 Days of Treatment - Period 2
Duration of first period of undisturbed sleep is defined as the length of time from initial sleep to first awakening. Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average length of first period of undisturbed sleep of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings.
Change From Baseline in Total Sleep Time at Approximately Day 32
Total sleep time is defined as the time spent asleep from initial sleep to final awakening. Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average of the total time asleep of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings.
Change From Baseline in Number of Daytime Voids at Approximately Day 32
Number of daytime voids was recorded over three consecutive days per week in diaries kept by study participants. The average number of daytime voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Change From Baseline in Number of 24-hour Urine Voids at Approximately Day 32
Number of voids in 24 hours was recorded over three consecutive days per week in diaries kept by study participants. The average number of 24-hour voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Change From Baseline in Nocturnal Urine Volume at Approximately Day 32
Nocturnal urine volume was recorded over three consecutive days per week in diaries kept by study participants. The average nocturnal urine volume of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Change From Baseline in 24-Hour Urine Volume at Approximately Day 32
Twenty-four hour urine volume was recorded over three consecutive days per week in diaries kept by study participants. The average 24-hour urine volume of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Change From Baseline in 24-Hour Urine Production Per Body Weight at Approximately Day 32
Twenty-four hour urine volume was recorded over three consecutive days per week in diaries kept by study participants. Urine volume per body weight was calculated. The average 24-hour urine volume per kg of body weight of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Change From Baseline in Nocturnal Polyuria Index at Approximately Day 32
Nocturnal polyuria index is defined as a proportion of nocturnal urine volume to the 24-hour urine volume. Urine volume and time of day of those voids was recorded over three consecutive days per week in diaries kept by study participants. The average nocturnal polyuria index of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Change From Baseline in Nocturia-Related Quality of Life Based on Evaluation Provided by Nocturia Quality of Life Questionnaire (N-QoL) at Approximately Day 32
N-QoL assesses the impact of nocturia on quality of life (QoL) and treatment outcomes. N-QoL is a self-administered questionnaire with 13 items using scales of 0 = no negative impact to QoL to the upper number = signficant negative impact to QoL. The sleep/energy domain consists of 7 questions with a scale of 0 to 28. The bother/concern domain consists of 5 questions for a scale of 0 to 20. The 13th question is an overall assessment scored from 0 to 10. The Total Score includes all 13 questions with a scale of 0 (no negative impact to QoL) to 58 (significant negative impact to QoL).
Change From Baseline in Sleep Related Quality of Life Based on the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Approximately Day 32
The Global Score of the Pittsburgh Sleep Quality Index (PSQI) is comprised of Questions 2-9 with a total scale of 0 (no difficulty sleeping) to 21 (severe difficulty). The change in Global Score is Global Score at the end of period 2 (day 32) - Global Score at the start of Period 2 (day 4). A negative change indicates an improvement in quality of life.
Participant Counts of Minimum Observed Serum Sodium Levels During the Second Treatment Period (Days 4-32)
Serum sodium levels were monitored throughout the trial as part of the clinical chemistry panel. If the value was ≤125 mEq/L, the participant was to be withdrawn from the trial and treatment stopped immediately. This outcome reports participants' lowest recorded serum sodium levels during the second treatment period.

Full Information

First Posted
August 18, 2010
Last Updated
April 24, 2012
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01184859
Brief Title
Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo
Acronym
NOC
Official Title
A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-group, Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo in Water-loaded Male and Female Japanese Nocturia Patients (Single Dose), and to Study the Efficacy of 4 Different Dose Levels of Minirin Melt and Placebo After 28 Days of Dosing (Multiple Doses)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (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
This is a multi-centre, randomised, placebo-controlled, double-blind, parallel-group comparative trial to be conducted in nocturia patients. The trial is designed to characterize the dose-response relationship of Minirin (desmopressin) Melt in order to establish correct dose recommendations in the target patient population. In particular, the trial is designed to link the duration of action to the clinical endpoint. Furthermore, the trial is designed to describe the safety of four different dose levels of desmopressin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia
Keywords
nocturia, bladder function

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Desmopressin 10µg
Arm Type
Experimental
Arm Description
Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
Arm Title
Desmopressin 25µg
Arm Type
Experimental
Arm Description
Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
Arm Title
Desmopressin 50µg
Arm Type
Experimental
Arm Description
Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
Arm Title
Desmopressin 100µg
Arm Type
Experimental
Arm Description
Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
Intervention Type
Drug
Intervention Name(s)
Desmopressin
Other Intervention Name(s)
FE992026, Minirin Melt
Intervention Description
Desmopressin oral lyophilisate melt tablet, in either the 10, 25, 50, or 100 μg dosage, for sublingual administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo melt tablet for sublingual administration
Primary Outcome Measure Information:
Title
Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1
Description
Participants were water-loaded to suppress the endogenous release of vasopressin, thus all antidiuretic activity was generated by desmopressin only. Water-loading was initiated 2 hours before dosing on Day 1. Urine volume was registered and samples for osmolality check were collected every 30 minutes as long as there was an antidiuretic action defined as a urine production <0.12 mL/kg/min. The hydration should have lasted until end of action, defined as when the urine production returned to >0.12 mL/kg/min, but no longer than 12 hours.
Time Frame
Day 1
Title
Change From Baseline in Number of Nocturnal Voids After 28 Days of Treatment - Period 2
Description
Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average number of nocturnal voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings.
Time Frame
3 days between study days -6 to 0 (Baseline), and days 25 to 32
Secondary Outcome Measure Information:
Title
Area Under the Urine Osmolality Curve (AUCosm)
Description
Area under the urine osmolality curve, from dose administration to end of action (AUCosm).
Time Frame
Day 1
Title
Area Under the Urine Production Curve (AUCurine Prod)
Description
Area under the urine production curve, from dose administration to end of action (AUCurine prod)
Time Frame
Day 1
Title
Time When Urine Production <0.12 ml/kg/Min
Description
Urine volume was registered and samples for osmolality check were collected every 30 minutes as long as there was an antidiuretic action defined as a urine production <0.12 mL/kg/min. The hydration due to water-loading should have lasted until end of action, defined as when the urine production returned to >0.12 mL/kg/min, but no longer than 12 hours.
Time Frame
Day 1
Title
Change From Baseline in Duration of First Period of Undisturbed Sleep After 28 Days of Treatment - Period 2
Description
Duration of first period of undisturbed sleep is defined as the length of time from initial sleep to first awakening. Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average length of first period of undisturbed sleep of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings.
Time Frame
3 days between study days -6 to 0 (Baseline), and days 25 to 32
Title
Change From Baseline in Total Sleep Time at Approximately Day 32
Description
Total sleep time is defined as the time spent asleep from initial sleep to final awakening. Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average of the total time asleep of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings.
Time Frame
3 days between study days -6 to 0 (Baseline), and days 25 to 32
Title
Change From Baseline in Number of Daytime Voids at Approximately Day 32
Description
Number of daytime voids was recorded over three consecutive days per week in diaries kept by study participants. The average number of daytime voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Time Frame
3 days between study days -6 to 0 (Baseline), and days 25 to 32
Title
Change From Baseline in Number of 24-hour Urine Voids at Approximately Day 32
Description
Number of voids in 24 hours was recorded over three consecutive days per week in diaries kept by study participants. The average number of 24-hour voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Time Frame
3 days between study days -6 to 0 (Baseline), and days 25 to 32
Title
Change From Baseline in Nocturnal Urine Volume at Approximately Day 32
Description
Nocturnal urine volume was recorded over three consecutive days per week in diaries kept by study participants. The average nocturnal urine volume of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Time Frame
3 days between study days -6 to 0 (Baseline), and days 25 to 32
Title
Change From Baseline in 24-Hour Urine Volume at Approximately Day 32
Description
Twenty-four hour urine volume was recorded over three consecutive days per week in diaries kept by study participants. The average 24-hour urine volume of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Time Frame
3 days between study days -6 to 0 (Baseline), and days 25 to 32
Title
Change From Baseline in 24-Hour Urine Production Per Body Weight at Approximately Day 32
Description
Twenty-four hour urine volume was recorded over three consecutive days per week in diaries kept by study participants. Urine volume per body weight was calculated. The average 24-hour urine volume per kg of body weight of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Time Frame
3 days between study days -6 to 0 (Baseline), and days 25 to 32
Title
Change From Baseline in Nocturnal Polyuria Index at Approximately Day 32
Description
Nocturnal polyuria index is defined as a proportion of nocturnal urine volume to the 24-hour urine volume. Urine volume and time of day of those voids was recorded over three consecutive days per week in diaries kept by study participants. The average nocturnal polyuria index of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Time Frame
3 days between study days -6 to 0 (Baseline), and days 25 to 32
Title
Change From Baseline in Nocturia-Related Quality of Life Based on Evaluation Provided by Nocturia Quality of Life Questionnaire (N-QoL) at Approximately Day 32
Description
N-QoL assesses the impact of nocturia on quality of life (QoL) and treatment outcomes. N-QoL is a self-administered questionnaire with 13 items using scales of 0 = no negative impact to QoL to the upper number = signficant negative impact to QoL. The sleep/energy domain consists of 7 questions with a scale of 0 to 28. The bother/concern domain consists of 5 questions for a scale of 0 to 20. The 13th question is an overall assessment scored from 0 to 10. The Total Score includes all 13 questions with a scale of 0 (no negative impact to QoL) to 58 (significant negative impact to QoL).
Time Frame
Approximately Day 4 (start of period 2) and Day 32
Title
Change From Baseline in Sleep Related Quality of Life Based on the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Approximately Day 32
Description
The Global Score of the Pittsburgh Sleep Quality Index (PSQI) is comprised of Questions 2-9 with a total scale of 0 (no difficulty sleeping) to 21 (severe difficulty). The change in Global Score is Global Score at the end of period 2 (day 32) - Global Score at the start of Period 2 (day 4). A negative change indicates an improvement in quality of life.
Time Frame
Approximately Day 4 (start of period 2) and Day 32
Title
Participant Counts of Minimum Observed Serum Sodium Levels During the Second Treatment Period (Days 4-32)
Description
Serum sodium levels were monitored throughout the trial as part of the clinical chemistry panel. If the value was ≤125 mEq/L, the participant was to be withdrawn from the trial and treatment stopped immediately. This outcome reports participants' lowest recorded serum sodium levels during the second treatment period.
Time Frame
Days 4- 32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Given written informed consent prior to any trial-related activity is performed Aged 55-75 years Mean number of nocturnal voids of at least two per night Reached post-menopause (applicable to females only) Exclusion Criteria: Evidence of bladder outlet obstruction (BOO); or a urine flow of less than 5 mL/s (applicable to males only) A surgical treatment for BOO or prostatic hyperplasia within the past 6 months (applicable to males only) Showing symptoms of any of the following diseases and having a mean number of nocturnal voids exceeding four per night: Benign prostatic hyperplasia, overactive bladder, interstitial cystitis, severe stress urinary incontinence Psychosomatic or habitual polydipsia Urinary retention; or a post void residual volume in excess of 150 mL A history or complication of urologic malignancy (e.g. bladder cancer or prostate cancer) Complication of genito-urinary pathology (e.g. infection, stone, or neoplasia) Complication of neurogenic detrusor activity Complication or suspicion of heart failure Uncontrolled hypertension Uncontrolled diabetes mellitus Complication of hepatobiliary disease Abnormal serum creatinine level Complication of hyponatraemia, or serum sodium level <135 mEq/L Central or nephrogenic diabetes insipidus (CDI or NDI) Syndrome of inappropriate antidiuretic hormone (SIADH) Obstructive sleep apnea Alcohol dependency or drug abuse A job or lifestyle that may interfere with regular night-time sleep Previous desmopressin treatment Treatment with another investigational product within the past 3 months A need for treatment with a prohibited concomitant drug for a complication or other problem A mental condition, the lack of decision-making ability, dementia or a speech handicap Any other reason that the Investigator believes inappropriate
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
Japanese Red Cross Nagoya Daiichi Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
National Center for Geriatrics and Gerontology
City
Obu
State/Province
Aichi
Country
Japan
Facility Name
Kokuho Asahi Central Hospital
City
Asahi
State/Province
Chiba
Country
Japan
Facility Name
University of Fukui Hospital
City
Yoshida
State/Province
Fukui
Country
Japan
Facility Name
Takayama Hospital
City
Chikushino
State/Province
Fukuoka
Country
Japan
Facility Name
Houshikai Group Kano Hospital
City
Koga
State/Province
Fukuoka
Country
Japan
Facility Name
St. Mary's Hospital
City
Kurume
State/Province
Fukuoka
Country
Japan
Facility Name
Jyusendo General Hospital
City
Koriyama
State/Province
Fukushima
Country
Japan
Facility Name
Social Insurance Nihonmatsu Hospital
City
Nihonmatsu
State/Province
Fukushima
Country
Japan
Facility Name
Takayama Clinic
City
Awagi
State/Province
Hyogo
Country
Japan
Facility Name
National Hospital Organization Kobe Medical Center
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Japanese Red Cross Mito Hospital
City
Mito
State/Province
Ibaraki
Country
Japan
Facility Name
Yokohama Shin-midori General Hospital
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Kumamoto Rosai Hospital
City
Yatsushiro
State/Province
Kumamoto
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Shinshu University Hospital
City
Matsumoto
State/Province
Nagano
Country
Japan
Facility Name
Senbokufujii Hospital
City
Sakai
State/Province
Osaka
Country
Japan
Facility Name
Kasukabe Chuo General Hospital
City
Kasukabe
State/Province
Saitama
Country
Japan
Facility Name
Hamamatsu University School of Medicine University Hospital
City
Hamamatsu
State/Province
Shizuoka
Country
Japan
Facility Name
Tokyo Women's Medical University Medical Center East
City
Arakawa
State/Province
Tokyo
Country
Japan
Facility Name
Koganeibashi Sakura Clinic
City
Koganei
State/Province
Tokyo
Country
Japan
Facility Name
Kunitachi Sakura Hospital
City
Kunitachi
State/Province
Tokyo
Country
Japan
Facility Name
University of Yamanashi Hospital
City
Chuo
State/Province
Yamanashi
Country
Japan
Facility Name
Harasanshin Hospital
City
Fukuoka
Country
Japan
Facility Name
Saku Hospital
City
Fukuoka
Country
Japan
Facility Name
Southwest Urological Clinic
City
Fukuoka
Country
Japan
Facility Name
Yakuin Urogenital Hospital
City
Fukuoka
Country
Japan
Facility Name
Fukushima Red Cross Hospital
City
Fukushima
Country
Japan
Facility Name
Ohara General Hospital
City
Fukushima
Country
Japan
Facility Name
Saiseikai Fukushima General Hospital
City
Fukushima
Country
Japan
Facility Name
Jigenji Kubo Clinic
City
Kagoshima
Country
Japan
Facility Name
Kawahara Hinyoukika
City
Kagoshima
Country
Japan
Facility Name
Yagi Clinic
City
Kagoshima
Country
Japan
Facility Name
Rakusai Newtown Hospital
City
Kyoto
Country
Japan
Facility Name
Suzuki Urological Clinic
City
Nagano
Country
Japan
Facility Name
Nanri Urological Clinic
City
Saga
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo

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