DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 1

Change 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017