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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

Short name NOC

NCTNCT01184859 (opens ClinicalTrials.gov in a new tab)Other idFE992026 CS36
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
116 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Randomized · Double masking
Countries
1 country

Japan

Start
Jul 2010
Primary completion
Apr 2011
Completion
Apr 2011
First posted
19 Aug 2010 (estimated)
Last update posted
25 May 2012 (estimated)
Conditions
Nocturia

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020112012
  1. Ph 2

    NOC

    NCT01184859

    Jul 2010 to Apr 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DesmopressinDrug
  • PlaceboDrug

Arms5

  • 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.

  • 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.

  • 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.

  • 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.

  • Placebo comparator

    Placebo

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

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1

    Time frame · Day 1

    Registry description

    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.

  2. 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

    Registry description

    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.

Secondary outcomes(14)

  1. Area Under the Urine Osmolality Curve (AUCosm)

    Time frame · Day 1

    Registry description

    Area under the urine osmolality curve, from dose administration to end of action (AUCosm).

  2. Area Under the Urine Production Curve (AUCurine Prod)

    Time frame · Day 1

    Registry description

    Area under the urine production curve, from dose administration to end of action (AUCurine prod)

  3. Time When Urine Production <0.12 ml/kg/Min

    Time frame · Day 1

    Registry description

    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.

  4. 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

    Registry description

    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.

  5. 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

    Registry description

    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.

  6. 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

    Registry description

    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.

  7. 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

    Registry description

    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.

  8. 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

    Registry description

    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.

  9. 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

    Registry description

    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.

  10. 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

    Registry description

    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.

  11. 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

    Registry description

    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.

  12. 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

    Registry description

    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).

  13. 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

    Registry description

    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.

  14. Participant Counts of Minimum Observed Serum Sodium Levels During the Second Treatment Period (Days 4-32)

    Time frame · Days 4- 32

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Day 1

Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1

GroupValue (hours)Spread
Placebo0.000.00
Desmopressin 10µg0.090.32
Desmopressin 25µg2.003.56
Desmopressin 50µg3.452.88
Desmopressin 100µg5.742.99
Primary outcomeLeast squares mean· 3 days between study days -6 to 0 (Baseline), and days 25 to 32

Change From Baseline in Number of Nocturnal Voids After 28 Days of Treatment - Period 2

GroupValue (nocturnal voids)
Placebo-0.735
Desmopressin 10µg-1.007
Desmopressin 25µg-1.282
Desmopressin 50µg-1.589
Desmopressin 100µg-1.624
Secondary and other outcome results(6)
Secondary outcomeMean· Day 1

Area Under the Urine Osmolality Curve (AUCosm)

GroupValue (h*mOsm/kg)Spread
Placebo0.000.00
Desmopressin 10µg24.6797.50
Desmopressin 25µg852.001576.10
Desmopressin 50µg1551.011501.21
Desmopressin 100µg3112.532131.69
Secondary outcomeMean· Day 1

Area Under the Urine Production Curve (AUCurine Prod)

GroupValue (h*mL)Spread
Placebo59.34153.78
Desmopressin 10µg214.24266.86
Desmopressin 25µg297.17322.51
Desmopressin 50µg522.99283.90
Desmopressin 100µg537.08330.67
Secondary outcomeMean· Day 1

Time When Urine Production <0.12 ml/kg/Min

GroupValue (hours)Spread
Placebo0.411.15
Desmopressin 10µg1.672.16
Desmopressin 25µg3.504.17
Desmopressin 50µg6.053.56
Desmopressin 100µg8.202.59
Secondary outcomeMean· 3 days between study days -6 to 0 (Baseline), and days 25 to 32

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

GroupValue (minutes)Spread
Placebo68.3993.32
Desmopressin 10µg101.85120.26
Desmopressin 25µg113.45120.22
Desmopressin 50µg190.77124.32
Desmopressin 100µg194.2599.17
Secondary outcomeMean· 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

GroupValue (minutes)Spread
Placebo2.4749.94
Desmopressin 10µg-11.8648.57
Desmopressin 25µg-33.04116.09
Desmopressin 50µg6.8169.04
Desmopressin 100µg14.0754.06
Secondary outcomeMean· 3 days between study days -6 to 0 (Baseline), and days 25 to 32

Change From Baseline in Number of Daytime Voids at Approximately Day 32

GroupValue (voids)Spread
Placebo0.491.33
Desmopressin 10µg0.681.53
Desmopressin 25µg0.151.66
Desmopressin 50µg0.231.51
Desmopressin 100µg0.631.74

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Placebo-Period 1Study period 1: single dose of placebo.–0 / 230 / 23
Desmopressin 10µg - Period 1Study period 1: single dose of desmopressin 10µg.–0 / 251 / 25
Desmopressin 25µg - Period 1Study period 1: single dose of desmopressin 25µg.–0 / 221 / 22
Desmopressin 50µg - Period 1Study period 1: single dose of desmopressin 50µg.–0 / 224 / 22
Desmopressin 100µg - Period 1Study period 1: single dose of desmopressin 100µg.–0 / 247 / 24
Placebo - Period 2Study period 2: daily doses of placebo taken before bedtime for 28 days.–0 / 233 / 23
Desmopressin 10µg - Period 2Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.–0 / 231 / 23
Desmopressin 25µg - Period 2Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.–0 / 224 / 22
Desmopressin 50µg - Period 2Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.–0 / 221 / 22
Desmopressin 100µg - Period 2Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.–0 / 230 / 23

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 55 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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