Phase 2 N=116 Randomized Double-blind Treatment

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

Nocturia

Bottom Line

View on ClinicalTrials.gov: NCT01184859 ↗

Enrolled (actual)

116

Serious AEs

0.0%

Results posted

May 2012

Primary outcome: Primary: Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1 — 0.00; 0.09; 2.00; 3.45 hours — p=0.211

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Desmopressin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: Ferring Pharmaceuticals
Primary completion: Apr 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1	0.00; 0.09; 2.00; 3.45; 5.74	0.211
PRIMARY Change From Baseline in Number of Nocturnal Voids After 28 Days of Treatment - Period 2	-0.735; -1.007; -1.282; -1.589; -1.624	0.194
SECONDARY Area Under the Urine Osmolality Curve (AUCosm)	0.00; 24.67; 852.00; 1551.01; 3112.53	—
SECONDARY Area Under the Urine Production Curve (AUCurine Prod)	59.34; 214.24; 297.17; 522.99; 537.08	—
SECONDARY Time When Urine Production <0.12 ml/kg/Min	0.41; 1.67; 3.50; 6.05; 8.20	—
SECONDARY Change From Baseline in Duration of First Period of Undisturbed Sleep After 28 Days of Treatment - Period 2	68.39; 101.85; 113.45; 190.77; 194.25	—
SECONDARY Change From Baseline in Total Sleep Time at Approximately Day 32	2.47; -11.86; -33.04; 6.81; 14.07	—
SECONDARY Change From Baseline in Number of Daytime Voids at Approximately Day 32	0.49; 0.68; 0.15; 0.23; 0.63	—
SECONDARY Change From Baseline in Number of 24-hour Urine Voids at Approximately Day 32	-0.15; -0.47; -1.19; -1.33; -0.96	—
SECONDARY Change From Baseline in Nocturnal Urine Volume at Approximately Day 32	-114.70; -140.68; -209.87; -295.02; -333.22	—
SECONDARY Change From Baseline in 24-Hour Urine Volume at Approximately Day 32	-104.47; -19.47; -201.83; -270.53; -187.25	—
SECONDARY Change From Baseline in 24-Hour Urine Production Per Body Weight at Approximately Day 32	-2.017; -0.096; -3.523; -4.573; -3.058	—
SECONDARY Change From Baseline in Nocturnal Polyuria Index at Approximately Day 32	-4.72; -7.82; -8.61; -13.56; -16.00	—
SECONDARY 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	7.77; 10.69; 13.26; 12.30; 8.52; 6.36	—
SECONDARY 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	-1.2; -0.6; -1.5; -1.4; -1.3	—
SECONDARY Participant Counts of Minimum Observed Serum Sodium Levels During the Second Treatment Period (Days 4-32)	23; 23; 21; 21; 23; 0	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01184859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.