Efficacy and safety of 25 and 50 μg desmopressin orally disintegrating tablets in Japanese patients with nocturia due to nocturnal polyuria: Results from two phase 3 studies of a multicenter randomized double-blind placebo-controlled parallel-group development program.

Yamaguchi O, Juul KV, Falahati A, Yoshimura T, Imura F, Kitamura M

Lower urinary tract symptoms9 Aug 2019Cited by 24 (Europe PMC)

PMID31397969PMCIDPMC7004048DOI10.1111/luts.12276PepBankPUB-31397969

Summary

This study assessed the efficacy and safety of desmopressin orally disintegrating tablets (ODTs) in Japanese males (50 and 25 μg) and females (25 μg) with nocturia due to nocturnal polyuria (NP). Two Phase 3 randomized double-blind placebo-controlled studies of 342 males and 190 females with nocturia due to NP were conducted. The primary endpoint was change from baseline in mean number of nocturnal voids. In addition, time to first awakening to void, nocturnal urine volume, NP index (NPI), and quality of life were assessed during a 12-week treatment period. In males, 50 and 25 μg desmopressin ODTs significantly reduced the number of nocturnal voids by -1.21 (P < .0001) and - 0.96 (P = .0143), respectively, and significantly prolonged the time to first awakening to void by 117.60 minutes (P < .0001) and 93.37 minute (P = .0009), respectively, with no safety concerns. In females, 25 μg desmopressin ODT significantly prolonged the time to first awakening to void by 116.11 minutes (P = .0257), with no safety concerns. The reduction in the number of nocturnal voids (-1.11) was not significantly different compared with placebo (P = .0975). Desmopressin ODTs (50 and 25 μg) were an effective and well-tolerated treatment for nocturia due to NP in Japanese males, and desmopressin ODT 50 μg is an appropriate dose in these patients. For patients who are likely to experience hyponatremia, such as elderly males, starting with 25 μg desmopressin ODT should be considered.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Japanese males with nocturnal polyuria, desmopressin 50 μg reduced nocturnal voids by -1.21, significantly versus placebo.
In plain wordsIn Japanese males with nocturnal polyuria, desmopressin 50 μg reduced night-time urination more than placebo.
Peptide
Desmopressin
Outcome
DecreaseNocturnal voids in males
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Urinary continence and bladder function · Kidney and urinary
Studied dose
50 μg · oral · 12 weeksAs given in this study (human).
Measurements
Nocturnal void change
−1.21 voids
reported result
P value
< 0.0001 unitless
reported result
Source sentences
Summary
In males, 50 and 25 μg desmopressin ODTs significantly reduced the number of nocturnal voids by -1.21 (P < .0001) and - 0.96 (P = .0143), respectively, and significantly prolonged the time to first awakening to void by 117.60 minutes (P < .0001) and 93.37 minute (P = .0009), respectively, with no safety concerns.
3 context sentences(design, population, supporting numbers)
Summary · context
This study assessed the efficacy and safety of desmopressin orally disintegrating tablets (ODTs) in Japanese males (50 and 25 μg) and females (25 μg) with nocturia due to nocturnal polyuria (NP).
Summary · context
Two Phase 3 randomized double-blind placebo-controlled studies of 342 males and 190 females with nocturia due to NP were conducted.
Summary · context
In addition, time to first awakening to void, nocturnal urine volume, NP index (NPI), and quality of life were assessed during a 12-week treatment period.
Show in the study text Report a problemFND-3139796901
02HumanRandomized controlled trialEfficacy outcome
In Japanese males with nocturnal polyuria, desmopressin 25 μg reduced nocturnal voids by -0.96, significantly versus placebo.
In plain wordsIn Japanese males with nocturnal polyuria, desmopressin 25 μg reduced night-time urination more than placebo.
Peptide
Desmopressin
Outcome
DecreaseNocturnal voids in males
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Urinary continence and bladder function · Kidney and urinary
Studied dose
25 μg · oral · 12 weeksAs given in this study (human).
Measurements
Nocturnal void change
−0.96 voids
reported result
P value
0.0143 unitless
reported result
Source sentences
Summary
In males, 50 and 25 μg desmopressin ODTs significantly reduced the number of nocturnal voids by -1.21 (P < .0001) and - 0.96 (P = .0143), respectively, and significantly prolonged the time to first awakening to void by 117.60 minutes (P < .0001) and 93.37 minute (P = .0009), respectively, with no safety concerns.
3 context sentences(design, population, supporting numbers)
Summary · context
This study assessed the efficacy and safety of desmopressin orally disintegrating tablets (ODTs) in Japanese males (50 and 25 μg) and females (25 μg) with nocturia due to nocturnal polyuria (NP).
Summary · context
Two Phase 3 randomized double-blind placebo-controlled studies of 342 males and 190 females with nocturia due to NP were conducted.
Summary · context
In addition, time to first awakening to void, nocturnal urine volume, NP index (NPI), and quality of life were assessed during a 12-week treatment period.
Show in the study text Report a problemFND-3139796902
03HumanRandomized controlled trialEfficacy outcome
In Japanese females with nocturnal polyuria, desmopressin reduced nocturnal voids by -1.11 without a significant difference versus placebo.
In plain wordsIn Japanese females with nocturnal polyuria, desmopressin did not significantly reduce night-time urination compared with placebo.
Peptide
Desmopressin
Outcome
No significant changeNocturnal voids in females
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Urinary continence and bladder function · Kidney and urinary
Studied dose
25 μg · oral · 12 weeksAs given in this study (human).
Measurements
Nocturnal void change
−1.11 voids
reported result
P value
0.0975 unitless
reported result
Source sentences
Summary
The reduction in the number of nocturnal voids (-1.11) was not significantly different compared with placebo (P = .0975).
4 context sentences(design, population, supporting numbers)
Summary · context
In females, 25 μg desmopressin ODT significantly prolonged the time to first awakening to void by 116.11 minutes (P = .0257), with no safety concerns.
Summary · context
This study assessed the efficacy and safety of desmopressin orally disintegrating tablets (ODTs) in Japanese males (50 and 25 μg) and females (25 μg) with nocturia due to nocturnal polyuria (NP).
Summary · context
Two Phase 3 randomized double-blind placebo-controlled studies of 342 males and 190 females with nocturia due to NP were conducted.
Summary · context
In addition, time to first awakening to void, nocturnal urine volume, NP index (NPI), and quality of life were assessed during a 12-week treatment period.
Show in the study text Report a problemFND-3139796908
04HumanRandomized controlled trialEfficacy outcome
In Japanese males with nocturnal polyuria, desmopressin 50 μg prolonged first awakening time by 117.60 minutes, significantly versus placebo.
In plain wordsIn Japanese males with nocturnal polyuria, desmopressin 50 μg delayed awakening to urinate more than placebo.
Peptide
Desmopressin
Outcome
IncreaseTime to first awakening in males
Study
n: not reported in source
Comparator
Placebo
Outcome group
Urinary continence and bladder function · Kidney and urinary
Studied dose
50 μg · oral · 12 weeksAs given in this study (human).
Measurements
Time prolongation
117.6 minutes
50 μg in males
P value
< 0.0001 unitless
50 μg in males
Source sentences
Summary
In males, 50 and 25 μg desmopressin ODTs significantly reduced the number of nocturnal voids by -1.21 (P < .0001) and - 0.96 (P = .0143), respectively, and significantly prolonged the time to first awakening to void by 117.60 minutes (P < .0001) and 93.37 minute (P = .0009), respectively, with no safety concerns.
3 context sentences(design, population, supporting numbers)
Summary · context
This study assessed the efficacy and safety of desmopressin orally disintegrating tablets (ODTs) in Japanese males (50 and 25 μg) and females (25 μg) with nocturia due to nocturnal polyuria (NP).
Summary · context
Two Phase 3 randomized double-blind placebo-controlled studies of 342 males and 190 females with nocturia due to NP were conducted.
Summary · context
In addition, time to first awakening to void, nocturnal urine volume, NP index (NPI), and quality of life were assessed during a 12-week treatment period.
Show in the study text Report a problemFND-3139796903
05HumanRandomized controlled trialEfficacy outcome
In Japanese males with nocturnal polyuria, desmopressin 25 μg prolonged first awakening time by 93.37 minutes, significantly versus placebo.
In plain wordsIn Japanese males with nocturnal polyuria, desmopressin 25 μg delayed awakening to urinate more than placebo.
Peptide
Desmopressin
Outcome
IncreaseTime to first awakening in males
Study
n: not reported in source
Comparator
Placebo
Outcome group
Urinary continence and bladder function · Kidney and urinary
Studied dose
25 μg · oral · 12 weeksAs given in this study (human).
Measurements
Time prolongation
93.37 minute
reported result
P value
0.0009 unitless
reported result
Source sentences
Summary
In males, 50 and 25 μg desmopressin ODTs significantly reduced the number of nocturnal voids by -1.21 (P < .0001) and - 0.96 (P = .0143), respectively, and significantly prolonged the time to first awakening to void by 117.60 minutes (P < .0001) and 93.37 minute (P = .0009), respectively, with no safety concerns.
3 context sentences(design, population, supporting numbers)
Summary · context
This study assessed the efficacy and safety of desmopressin orally disintegrating tablets (ODTs) in Japanese males (50 and 25 μg) and females (25 μg) with nocturia due to nocturnal polyuria (NP).
Summary · context
Two Phase 3 randomized double-blind placebo-controlled studies of 342 males and 190 females with nocturia due to NP were conducted.
Summary · context
In addition, time to first awakening to void, nocturnal urine volume, NP index (NPI), and quality of life were assessed during a 12-week treatment period.
Show in the study text Report a problemFND-3139796904
06HumanRandomized controlled trialEfficacy outcome
In Japanese females with nocturnal polyuria, desmopressin prolonged first awakening time by 116.11 minutes, significantly versus placebo.
In plain wordsIn Japanese females with nocturnal polyuria, desmopressin delayed awakening to urinate more than placebo.
Peptide
Desmopressin
Outcome
IncreaseTime to first awakening in females
Study
n: not reported in source
Comparator
Placebo
Outcome group
Urinary continence and bladder function · Kidney and urinary
Studied dose
25 μg · oral · 12 weeksAs given in this study (human).
Measurements
Time prolongation
116.11 minutes
reported result
P value
0.0257 unitless
reported result
Source sentences
Summary
In females, 25 μg desmopressin ODT significantly prolonged the time to first awakening to void by 116.11 minutes (P = .0257), with no safety concerns.
3 context sentences(design, population, supporting numbers)
Summary · context
This study assessed the efficacy and safety of desmopressin orally disintegrating tablets (ODTs) in Japanese males (50 and 25 μg) and females (25 μg) with nocturia due to nocturnal polyuria (NP).
Summary · context
Two Phase 3 randomized double-blind placebo-controlled studies of 342 males and 190 females with nocturia due to NP were conducted.
Summary · context
In addition, time to first awakening to void, nocturnal urine volume, NP index (NPI), and quality of life were assessed during a 12-week treatment period.
Show in the study text Report a problemFND-3139796906
07HumanNon-randomized trialSafety outcome
In Japanese males with nocturnal polyuria, desmopressin treatment raised no safety concerns.
In plain wordsIn Japanese males with nocturnal polyuria, desmopressin raised no safety concerns.
Peptide
Desmopressin
Outcome
Direction not reportedSafety concerns in males
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
25 and 50 μg · oral · 12 weeksAs given in this study (human).
Source sentences
Summary
In males, 50 and 25 μg desmopressin ODTs significantly reduced the number of nocturnal voids by -1.21 (P < .0001) and - 0.96 (P = .0143), respectively, and significantly prolonged the time to first awakening to void by 117.60 minutes (P < .0001) and 93.37 minute (P = .0009), respectively, with no safety concerns.
3 context sentences(design, population, supporting numbers)
Summary · context
This study assessed the efficacy and safety of desmopressin orally disintegrating tablets (ODTs) in Japanese males (50 and 25 μg) and females (25 μg) with nocturia due to nocturnal polyuria (NP).
Summary · context
Two Phase 3 randomized double-blind placebo-controlled studies of 342 males and 190 females with nocturia due to NP were conducted.
Summary · context
In addition, time to first awakening to void, nocturnal urine volume, NP index (NPI), and quality of life were assessed during a 12-week treatment period.
Show in the study text Report a problemFND-3139796905
08HumanNon-randomized trialSafety outcome
In Japanese females with nocturnal polyuria, desmopressin treatment raised no safety concerns.
In plain wordsIn Japanese females with nocturnal polyuria, desmopressin raised no safety concerns.
Peptide
Desmopressin
Outcome
Direction not reportedSafety concerns in females
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
25 μg · oral · 12 weeksAs given in this study (human).
Source sentences
Summary
In females, 25 μg desmopressin ODT significantly prolonged the time to first awakening to void by 116.11 minutes (P = .0257), with no safety concerns.
3 context sentences(design, population, supporting numbers)
Summary · context
This study assessed the efficacy and safety of desmopressin orally disintegrating tablets (ODTs) in Japanese males (50 and 25 μg) and females (25 μg) with nocturia due to nocturnal polyuria (NP).
Summary · context
Two Phase 3 randomized double-blind placebo-controlled studies of 342 males and 190 females with nocturia due to NP were conducted.
Summary · context
In addition, time to first awakening to void, nocturnal urine volume, NP index (NPI), and quality of life were assessed during a 12-week treatment period.
Show in the study text Report a problemFND-3139796907

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT02904759

Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Male Subjects

Ferring Pharmaceuticalsn = 342Sept 2016 to 29 Sept 2017

Nocturia

Trial page ClinicalTrials.govUpdated 11 Sept 2019

CompletedPhase 3NCT02905682

Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Female Subjects

Ferring Pharmaceuticalsn = 190Sept 2016 to 27 Sept 2017

Nocturia

Trial page ClinicalTrials.govUpdated 11 Sept 2019

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:35 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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