Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo
Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nocturia
Intervention: Desmopressin (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Ferring Pharmaceuticals Official(s) and/or principal investigator(s): Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1Change From Baseline in Number of Nocturnal Voids After 28 Days of Treatment - Period 2
Secondary outcome: Area Under the Urine Osmolality Curve (AUCosm)Area Under the Urine Production Curve (AUCurine Prod) Time When Urine Production <0.12 ml/kg/Min Change From Baseline in Duration of First Period of Undisturbed Sleep After 28 Days of Treatment - Period 2 Change From Baseline in Total Sleep Time at Approximately Day 32 Change From Baseline in Number of Daytime Voids at Approximately Day 32 Change From Baseline in Number of 24-hour Urine Voids at Approximately Day 32 Change From Baseline in Nocturnal Urine Volume at Approximately Day 32 Change From Baseline in 24-Hour Urine Volume at Approximately Day 32 Change From Baseline in 24-Hour Urine Production Per Body Weight at Approximately Day 32 Change From Baseline in Nocturnal Polyuria Index at Approximately Day 32 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 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 Participant Counts of Minimum Observed Serum Sodium Levels During the Second Treatment Period (Days 4-32)
Eligibility
Minimum age: 55 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Harasanshin Hospital, Fukuoka, Japan
Saku Hospital, Fukuoka, Japan
Southwest Urological Clinic, Fukuoka, Japan
Yakuin Urogenital Hospital, Fukuoka, Japan
Fukushima Red Cross Hospital, Fukushima, Japan
Ohara General Hospital, Fukushima, Japan
Saiseikai Fukushima General Hospital, Fukushima, Japan
Jigenji Kubo Clinic, Kagoshima, Japan
Kawahara Hinyoukika, Kagoshima, Japan
Yagi Clinic, Kagoshima, Japan
Rakusai Newtown Hospital, Kyoto, Japan
Suzuki Urological Clinic, Nagano, Japan
Nanri Urological Clinic, Saga, Japan
Japanese Red Cross Nagoya Daiichi Hospital, Nagoya, Aichi, Japan
National Center for Geriatrics and Gerontology, Obu, Aichi, Japan
Kokuho Asahi Central Hospital, Asahi, Chiba, Japan
University of Fukui Hospital, Yoshida, Fukui, Japan
Takayama Hospital, Chikushino, Fukuoka, Japan
Houshikai Group Kano Hospital, Koga, Fukuoka, Japan
St. Mary's Hospital, Kurume, Fukuoka, Japan
Jyusendo General Hospital, Koriyama, Fukushima, Japan
Social Insurance Nihonmatsu Hospital, Nihonmatsu, Fukushima, Japan
Takayama Clinic, Awagi, Hyogo, Japan
National Hospital Organization Kobe Medical Center, Kobe, Hyogo, Japan
Japanese Red Cross Mito Hospital, Mito, Ibaraki, Japan
Yokohama Shin-midori General Hospital, Yokohama, Kanagawa, Japan
Kumamoto Rosai Hospital, Yatsushiro, Kumamoto, Japan
Tohoku University Hospital, Sendai, Miyagi, Japan
Shinshu University Hospital, Matsumoto, Nagano, Japan
Senbokufujii Hospital, Sakai, Osaka, Japan
Kasukabe Chuo General Hospital, Kasukabe, Saitama, Japan
Hamamatsu University School of Medicine University Hospital, Hamamatsu, Shizuoka, Japan
Tokyo Women's Medical University Medical Center East, Arakawa, Tokyo, Japan
Koganeibashi Sakura Clinic, Koganei, Tokyo, Japan
Kunitachi Sakura Hospital, Kunitachi, Tokyo, Japan
University of Yamanashi Hospital, Chuo, Yamanashi, Japan
Additional Information
Starting date: July 2010
Last updated: April 24, 2012
|