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

NCT01184859 | Completed Phase 2 Results

• 1 other identifier: FE992026 CS36
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 36

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

Keywords

nocturia; bladder function

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 1

• 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.

  3 days between study days -6 to 0 (Baseline), and days 25 to 32

Secondary Outcomes (14)

• Area Under the Urine Osmolality Curve (AUCosm)

  Day 1

• Area Under the Urine Production Curve (AUCurine Prod)

  Day 1

• Time When Urine Production <0.12 ml/kg/Min

  Day 1

• Change From Baseline in Duration of First Period of Undisturbed Sleep After 28 Days of Treatment - Period 2

  3 days between study days -6 to 0 (Baseline), and days 25 to 32

• Change From Baseline in Total Sleep Time at Approximately Day 32

  3 days between study days -6 to 0 (Baseline), and days 25 to 32

Study Arms (5)

Desmopressin 10µg

EXPERIMENTAL

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

Drug: Desmopressin

Desmopressin 25µg

EXPERIMENTAL

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

Drug: Desmopressin

Desmopressin 50µg

EXPERIMENTAL

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

Drug: Desmopressin

Desmopressin 100µg

EXPERIMENTAL

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

Drug: Desmopressin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Desmopressin DRUG

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

Also known as: FE992026, Minirin Melt

Desmopressin 100µg; Desmopressin 10µg; Desmopressin 25µg; Desmopressin 50µg

Placebo DRUG

Placebo melt tablet for sublingual administration

Placebo

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (36)

Japanese Red Cross Nagoya Daiichi Hospital

Nagoya, Aichi-ken, Japan

Location

National Center for Geriatrics and Gerontology

Ōbu, Aichi-ken, Japan

Location

Kokuho Asahi Central Hospital

Asahi, Chiba, Japan

Location

University of Fukui Hospital

Yoshida, Fukui, Japan

Location

Takayama Hospital

Chikushino-shi, Fukuoka, Japan

Location

Harasanshin Hospital

Fukuoka, Fukuoka, Japan

Location

Saku Hospital

Fukuoka, Fukuoka, Japan

Location

Southwest Urological Clinic

Fukuoka, Fukuoka, Japan

Location

Yakuin Urogenital Hospital

Fukuoka, Fukuoka, Japan

Location

Houshikai Group Kano Hospital

Koga, Fukuoka, Japan

Location

St. Mary's Hospital

Kurume, Fukuoka, Japan

Location

Fukushima Red Cross Hospital

Fukushima, Fukushima, Japan

Location

Ohara General Hospital

Fukushima, Fukushima, Japan

Location

Saiseikai Fukushima General Hospital

Fukushima, Fukushima, Japan

Location

Jyusendo General Hospital

Kōriyama, Fukushima, Japan

Location

Social Insurance Nihonmatsu Hospital

Nihommatsu, Fukushima, Japan

Location

Takayama Clinic

Awagi, Hyōgo, Japan

Location

National Hospital Organization Kobe Medical Center

Kobe, Hyōgo, Japan

Location

Japanese Red Cross Mito Hospital

Mito, Ibaraki, Japan

Location

Jigenji Kubo Clinic

Kagoshima, Kagoshima-ken, Japan

Location

Kawahara Hinyoukika

Kagoshima, Kagoshima-ken, Japan

Location

Yagi Clinic

Kagoshima, Kagoshima-ken, Japan

Location

Yokohama Shin-midori General Hospital

Yokohama, Kanagawa, Japan

Location

Kumamoto Rosai Hospital

Yatsushiro, Kumamoto, Japan

Location

Rakusai Newtown Hospital

Kyoto, Kyoto, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, Japan

Location

Shinshu University Hospital

Matsumoto, Nagano, Japan

Location

Suzuki Urological Clinic

Nagano, Nagano, Japan

Location

Senbokufujii Hospital

Sakai, Osaka, Japan

Location

Nanri Urological Clinic

Saga, Saga-ken, Japan

Location

Kasukabe Chuo General Hospital

Kasukabe, Saitama, Japan

Location

Hamamatsu University School of Medicine University Hospital

Hamamatsu, Shizuoka, Japan

Location

Tokyo Women's Medical University Medical Center East

Arakawa City, Tokyo, Japan

Location

Koganeibashi Sakura Clinic

Koganei, Tokyo, Japan

Location

Kunitachi Sakura Hospital

Kunitachi, Tokyo, Japan

Location

University of Yamanashi Hospital

Chūō, Yamanashi, Japan

Location

MeSH Terms

Conditions

Nocturia

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2010
• First Posted: August 19, 2010
• Study Start: July 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 25, 2012
• Results First Posted: May 25, 2012

Record last verified: 2012-04

Locations

JP (36)