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

NCT ID: NCT01184859

Last Updated: 2012-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-04-30

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.

Conditions

Nocturia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Desmopressin 10µg

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

Group Type: EXPERIMENTAL

Desmopressin

Intervention Type: DRUG

Desmopressin oral lyophilisate melt tablet, in either the 10, 25, 50, or 100 μg dosage, for sublingual administration

Desmopressin 25µg

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

Group Type: EXPERIMENTAL

Desmopressin

Intervention Type: DRUG

Desmopressin oral lyophilisate melt tablet, in either the 10, 25, 50, or 100 μg dosage, for sublingual administration

Desmopressin 50µg

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

Group Type: EXPERIMENTAL

Desmopressin

Intervention Type: DRUG

Desmopressin oral lyophilisate melt tablet, in either the 10, 25, 50, or 100 μg dosage, for sublingual administration

Desmopressin 100µg

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

Group Type: EXPERIMENTAL

Desmopressin

Intervention Type: DRUG

Desmopressin oral lyophilisate melt tablet, in either the 10, 25, 50, or 100 μg dosage, for sublingual administration

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo melt tablet for sublingual administration

Interventions

Desmopressin

Desmopressin oral lyophilisate melt tablet, in either the 10, 25, 50, or 100 μg dosage, for sublingual administration

Intervention Type: DRUG

Placebo

Placebo melt tablet for sublingual administration

Intervention Type: DRUG

Other Intervention Names

FE992026; Minirin Melt

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

Japanese Red Cross Nagoya Daiichi Hospital

Nagoya, Aichi-ken, Japan

National Center for Geriatrics and Gerontology

Ōbu, Aichi-ken, Japan

Kokuho Asahi Central Hospital

Asahi, Chiba, Japan

University of Fukui Hospital

Yoshida, Fukui, Japan

Takayama Hospital

Chikushino-shi, Fukuoka, Japan

Harasanshin Hospital

Fukuoka, Fukuoka, Japan

Saku Hospital

Fukuoka, Fukuoka, Japan

Southwest Urological Clinic

Fukuoka, Fukuoka, Japan

Yakuin Urogenital Hospital

Fukuoka, Fukuoka, Japan

Houshikai Group Kano Hospital

Koga, Fukuoka, Japan

St. Mary's Hospital

Kurume, Fukuoka, Japan

Fukushima Red Cross Hospital

Fukushima, Fukushima, Japan

Ohara General Hospital

Fukushima, Fukushima, Japan

Saiseikai Fukushima General Hospital

Fukushima, Fukushima, Japan

Jyusendo General Hospital

Kōriyama, Fukushima, Japan

Social Insurance Nihonmatsu Hospital

Nihommatsu, Fukushima, Japan

Takayama Clinic

Awagi, Hyōgo, Japan

National Hospital Organization Kobe Medical Center

Kobe, Hyōgo, Japan

Japanese Red Cross Mito Hospital

Mito, Ibaraki, Japan

Jigenji Kubo Clinic

Kagoshima, Kagoshima-ken, Japan

Kawahara Hinyoukika

Kagoshima, Kagoshima-ken, Japan

Yagi Clinic

Kagoshima, Kagoshima-ken, Japan

Yokohama Shin-midori General Hospital

Yokohama, Kanagawa, Japan

Kumamoto Rosai Hospital

Yatsushiro, Kumamoto, Japan

Rakusai Newtown Hospital

Kyoto, Kyoto, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Shinshu University Hospital

Matsumoto, Nagano, Japan

Suzuki Urological Clinic

Nagano, Nagano, Japan

Senbokufujii Hospital

Sakai, Osaka, Japan

Nanri Urological Clinic

Saga, Saga-ken, 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 City, Tokyo, Japan

Koganeibashi Sakura Clinic

Koganei, Tokyo, Japan

Kunitachi Sakura Hospital

Kunitachi, Tokyo, Japan

University of Yamanashi Hospital

Chūō, Yamanashi, Japan

Countries

Japan

Other Identifiers

FE992026 CS36

Identifier Type: -

Identifier Source: org_study_id