Clinical trial NCT01184859: Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nocturia
Keywords: nocturia
bladder function
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-08-19
Enrollment: 116
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1
timeFrame: Day 1
measure: Change From Baseline in Number of Nocturnal Voids After 28 Days of Treatment - Period 2
timeFrame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Secondary outcomes:
measure: Area Under the Urine Osmolality Curve (AUCosm)
timeFrame: Day 1
measure: Area Under the Urine Production Curve (AUCurine Prod)
timeFrame: Day 1
measure: Time When Urine Production <0.12 ml/kg/Min
timeFrame: Day 1
measure: Change From Baseline in Duration of First Period of Undisturbed Sleep After 28 Days of Treatment - Period 2
timeFrame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
measure: Change From Baseline in Total Sleep Time at Approximately Day 32
timeFrame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
measure: Change From Baseline in Number of Daytime Voids at Approximately Day 32
timeFrame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
measure: Change From Baseline in Number of 24-hour Urine Voids at Approximately Day 32
timeFrame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
measure: Change From Baseline in Nocturnal Urine Volume at Approximately Day 32
timeFrame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
measure: Change From Baseline in 24-Hour Urine Volume at Approximately Day 32
timeFrame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
measure: Change From Baseline in 24-Hour Urine Production Per Body Weight at Approximately Day 32
timeFrame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
measure: Change From Baseline in Nocturnal Polyuria Index at Approximately Day 32
timeFrame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
measure: 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
timeFrame: Approximately Day 4 (start of period 2) and Day 32
measure: 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
timeFrame: Approximately Day 4 (start of period 2) and Day 32
measure: Participant Counts of Minimum Observed Serum Sodium Levels During the Second Treatment Period (Days 4-32)
timeFrame: Days 4- 32
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Japanese Red Cross Nagoya Daiichi Hospital
state: Aichi
city: Obu
country: Japan
facility: National Center for Geriatrics and Gerontology
state: Aichi
city: Asahi
country: Japan
facility: Kokuho Asahi Central Hospital
state: Chiba
city: Yoshida
country: Japan
facility: University of Fukui Hospital
state: Fukui
city: Chikushino
country: Japan
facility: Takayama Hospital
state: Fukuoka
city: Koga
country: Japan
facility: Houshikai Group Kano Hospital
state: Fukuoka
city: Kurume
country: Japan
facility: St. Mary's Hospital
state: Fukuoka
city: Koriyama
country: Japan
facility: Jyusendo General Hospital
state: Fukushima
city: Nihonmatsu
country: Japan
facility: Social Insurance Nihonmatsu Hospital
state: Fukushima
city: Awagi
country: Japan
facility: Takayama Clinic
state: Hyogo
city: Kobe
country: Japan
facility: National Hospital Organization Kobe Medical Center
state: Hyogo
city: Mito
country: Japan
facility: Japanese Red Cross Mito Hospital
state: Ibaraki
city: Yokohama
country: Japan
facility: Yokohama Shin-midori General Hospital
state: Kanagawa
city: Yatsushiro
country: Japan
facility: Kumamoto Rosai Hospital
state: Kumamoto
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
state: Nagano
city: Sakai
country: Japan
facility: Senbokufujii Hospital
state: Osaka
city: Kasukabe
country: Japan
facility: Kasukabe Chuo General Hospital
state: Saitama
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine University Hospital
state: Shizuoka
city: Arakawa
country: Japan
facility: Tokyo Women's Medical University Medical Center East
state: Tokyo
city: Koganei
country: Japan
facility: Koganeibashi Sakura Clinic
state: Tokyo
city: Kunitachi
country: Japan
facility: Kunitachi Sakura Hospital
state: Tokyo
city: Chuo
country: Japan
facility: University of Yamanashi Hospital
state: Yamanashi
city: Fukuoka
country: Japan
facility: Harasanshin Hospital
city: Fukuoka
country: Japan
facility: Saku Hospital
city: Fukuoka
country: Japan
facility: Southwest Urological Clinic
city: Fukuoka
country: Japan
facility: Yakuin Urogenital Hospital
city: Fukushima
country: Japan
facility: Fukushima Red Cross Hospital
city: Fukushima
country: Japan
facility: Ohara General Hospital
city: Fukushima
country: Japan
facility: Saiseikai Fukushima General Hospital
city: Kagoshima
country: Japan
facility: Jigenji Kubo Clinic
city: Kagoshima
country: Japan
facility: Kawahara Hinyoukika
city: Kagoshima
country: Japan
facility: Yagi Clinic
city: Kyoto
country: Japan
facility: Rakusai Newtown Hospital
city: Nagano
country: Japan
facility: Suzuki Urological Clinic
city: Saga
country: Japan
facility: Nanri Urological Clinic
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: