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

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ClinicalTrials.gov Identifier: NCT01184859
Recruitment Status : Completed
First Posted : August 19, 2010
Results First Posted : May 25, 2012
Last Update Posted : May 25, 2012
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE August 18, 2010
First Posted Date  ICMJE August 19, 2010
Results First Submitted Date  ICMJE April 24, 2012
Results First Posted Date  ICMJE May 25, 2012
Last Update Posted Date May 25, 2012
Study Start Date  ICMJE July 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2012)
  • Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1 [ Time Frame: Day 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.
  • Change From Baseline in Number of Nocturnal Voids After 28 Days of Treatment - Period 2 [ Time Frame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2010)
  • Reduction in number of nocturnal voids [ Time Frame: From baseline after 28 days of treatment with the investigational medicinal product (Treatment Period 2) ]
  • Time with urine osmolality above 200 mOsm/kg [ Time Frame: Day 1 (Treatment Period 1) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2012)
  • Area Under the Urine Osmolality Curve (AUCosm) [ Time Frame: Day 1 ]
    Area under the urine osmolality curve, from dose administration to end of action (AUCosm).
  • Area Under the Urine Production Curve (AUCurine Prod) [ Time Frame: Day 1 ]
    Area under the urine production curve, from dose administration to end of action (AUCurine prod)
  • Time When Urine Production <0.12 ml/kg/Min [ Time Frame: 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 due to water-loading 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.
  • Change From Baseline in Duration of First Period of Undisturbed Sleep After 28 Days of Treatment - Period 2 [ Time Frame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32 ]
    Duration of first period of undisturbed sleep is defined as the length of time from initial sleep to first awakening. Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average length of first period of undisturbed sleep of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings.
  • Change From Baseline in Total Sleep Time at Approximately Day 32 [ Time Frame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32 ]
    Total sleep time is defined as the time spent asleep from initial sleep to final awakening. Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average of the total time asleep of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings.
  • Change From Baseline in Number of Daytime Voids at Approximately Day 32 [ Time Frame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32 ]
    Number of daytime voids was recorded over three consecutive days per week in diaries kept by study participants. The average number of daytime voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
  • Change From Baseline in Number of 24-hour Urine Voids at Approximately Day 32 [ Time Frame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32 ]
    Number of voids in 24 hours was recorded over three consecutive days per week in diaries kept by study participants. The average number of 24-hour voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
  • Change From Baseline in Nocturnal Urine Volume at Approximately Day 32 [ Time Frame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32 ]
    Nocturnal urine volume was recorded over three consecutive days per week in diaries kept by study participants. The average nocturnal urine volume of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
  • Change From Baseline in 24-Hour Urine Volume at Approximately Day 32 [ Time Frame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32 ]
    Twenty-four hour urine volume was recorded over three consecutive days per week in diaries kept by study participants. The average 24-hour urine volume of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
  • Change From Baseline in 24-Hour Urine Production Per Body Weight at Approximately Day 32 [ Time Frame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32 ]
    Twenty-four hour urine volume was recorded over three consecutive days per week in diaries kept by study participants. Urine volume per body weight was calculated. The average 24-hour urine volume per kg of body weight of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
  • Change From Baseline in Nocturnal Polyuria Index at Approximately Day 32 [ Time Frame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32 ]
    Nocturnal polyuria index is defined as a proportion of nocturnal urine volume to the 24-hour urine volume. Urine volume and time of day of those voids was recorded over three consecutive days per week in diaries kept by study participants. The average nocturnal polyuria index of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
  • 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 [ Time Frame: Approximately Day 4 (start of period 2) and Day 32 ]
    N-QoL assesses the impact of nocturia on quality of life (QoL) and treatment outcomes. N-QoL is a self-administered questionnaire with 13 items using scales of 0 = no negative impact to QoL to the upper number = signficant negative impact to QoL. The sleep/energy domain consists of 7 questions with a scale of 0 to 28. The bother/concern domain consists of 5 questions for a scale of 0 to 20. The 13th question is an overall assessment scored from 0 to 10. The Total Score includes all 13 questions with a scale of 0 (no negative impact to QoL) to 58 (significant negative impact to QoL).
  • 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 [ Time Frame: Approximately Day 4 (start of period 2) and Day 32 ]
    The Global Score of the Pittsburgh Sleep Quality Index (PSQI) is comprised of Questions 2-9 with a total scale of 0 (no difficulty sleeping) to 21 (severe difficulty). The change in Global Score is Global Score at the end of period 2 (day 32) - Global Score at the start of Period 2 (day 4). A negative change indicates an improvement in quality of life.
  • Participant Counts of Minimum Observed Serum Sodium Levels During the Second Treatment Period (Days 4-32) [ Time Frame: Days 4- 32 ]
    Serum sodium levels were monitored throughout the trial as part of the clinical chemistry panel. If the value was ≤125 mEq/L, the participant was to be withdrawn from the trial and treatment stopped immediately. This outcome reports participants' lowest recorded serum sodium levels during the second treatment period.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2010)
  • Area under the urine osmolality curve, from dose administration to end of action (AUCosm) [ Time Frame: Day 1 (Treatment Period 1) ]
  • Area under the urine production curve, from dose administration to end of action (AUCurine prod) [ Time Frame: Day 1 (Treatment Period 1) ]
  • Time with urine production <0.12 mL/kg/min [ Time Frame: Day 1 (Treatment Period 1) ]
  • First period of undisturbed sleep [ Time Frame: From baseline after 28 days of treatment with the investigational medicinal product (Treatment Period 2) ]
  • Total sleep time [ Time Frame: From baseline after 28 days of treatment with the investigational medicinal product (Treatment Period 2) ]
  • Nocturnal urine volume [ Time Frame: From baseline after 28 days of treatment with the investigational medicinal product (Treatment Period 2) ]
  • 24-hour urine volume [ Time Frame: From baseline after 28 days of treatment with the investigational medicinal product (Treatment Period 2) ]
  • 24-hour urine production per body weight (mL/kg) [ Time Frame: From baseline after 28 days of treatment with the investigational medicinal product (Treatment Period 2) ]
  • Nocturnal polyuria index [ Time Frame: From baseline after 28 days of treatment with the investigational medicinal product (Treatment Period 2) ]
  • Number of daytime voids [ Time Frame: From baseline after 28 days of treatment with the investigational medicinal product (Treatment Period 2) ]
  • Number of 24-hour voids [ Time Frame: From baseline after 28 days of treatment with the investigational medicinal product (Treatment Period 2) ]
  • Sleep-related QoL [ Time Frame: From baseline after 28 days of treatment with the investigational medicinal product (Treatment Period 2) ]
  • Serum sodium level [ Time Frame: From baseline after 28 days of treatment with the investigational medicinal product (Treatment Period 2) ]
  • Incidence and severity of adverse events. Abnormal laboratory test values and vital signs [ Time Frame: From getting informed consent after 28 days of treatment with the investigational medicinal product (Treatment Period 1 and 2) ]
  • Nocturia-related QoL [ Time Frame: From baseline after 28 days of treatment with the investigational medicinal product (Treatment Period 2) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Nocturia
Intervention  ICMJE
  • Drug: Desmopressin
    Desmopressin oral lyophilisate melt tablet, in either the 10, 25, 50, or 100 μg dosage, for sublingual administration
    Other Names:
    • FE992026
    • Minirin Melt
  • Drug: Placebo
    Placebo melt tablet for sublingual administration
Study Arms  ICMJE
  • Experimental: Desmopressin 10µg
    Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
    Intervention: Drug: Desmopressin
  • Experimental: Desmopressin 25µg
    Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
    Intervention: Drug: Desmopressin
  • Experimental: Desmopressin 50µg
    Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
    Intervention: Drug: Desmopressin
  • Experimental: Desmopressin 100µg
    Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
    Intervention: Drug: Desmopressin
  • Placebo Comparator: Placebo
    Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2012)
116
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2010)
100
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01184859
Other Study ID Numbers  ICMJE FE992026 CS36
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ferring Pharmaceuticals
Study Sponsor  ICMJE Ferring Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Development Support Ferring Pharmaceuticals
PRS Account Ferring Pharmaceuticals
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP