Trial reportLower urinary tract symptoms2020
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.
Trial report in Lower urinary tract symptoms, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomised, Double-blind, Placebo-controlled, Multi-centre Trial Investigating the Efficacy and Safety of Desmopressin (FE 992026) Orally Disintegrating Tablets During 12 Weeks of Treatment for Nocturia Due to Nocturnal Polyuria in Japanese Male Subjects
A Randomised, Double-blind, Placebo-controlled, Multi-centre Trial Investigating the Efficacy and Safety of Desmopressin (FE 992026) Orally Disintegrating Tablets During 12 Weeks of Treatment for Nocturia Due to Nocturnal Polyuria in Japanese Female Subjects
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.
- Korean guideline of desmopressin for the treatment of nocturia in men.Investigative and clinical urology · 2022Guideline
- 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.Lower urinary tract symptoms · 2020Trial
- Association between light exposure and sleep problems related to nocturia in older adults: the Nagahama study.Journal of physiological anthropology · 2026Article
- Long-Term Safety of Desmopressin Orally Disintegrating Tablets in Men With Nocturia due to Nocturnal Polyuria: Final Results of a Specified Drug Use-Results Survey in Japan.Lower urinary tract symptoms · 2026Article
- Model of Nocturnal Polyuria in Older Japanese Adults Receiving Enteral Nutrition in Medical Long-Term Care Hospitals: An Exploratory Cross-Sectional Study.Lower urinary tract symptoms · 2026Observational
- Real-life safety assessment of orally disintegrating desmopressin tablet: Incidence of diagnosed hyponatraemia and other events across three European countries.Global epidemiology · 2025Article
- Risk factors for hyponatremia associated with desmopressin use.Translational andrology and urology · 2024Article
- Long-term safety of desmopressin orally disintegrating tablets in men with nocturia due to nocturnal polyuria: Interim results of a specified drug use-results survey in Japan.Lower urinary tract symptoms · 2024Article
- Effectiveness and Safety of a Mixture of Nobiletin and Tangeretin in Nocturia Patients: A Randomized, Placebo-Controlled, Double-Blind, Crossover Study.Journal of clinical medicine · 2023Article
- Selection of AVP-Shortage Patients as Candidates for Low-Dose Oral Desmopressin Administration.Research and reports in urology · 2021Article
- Investigation of Effect Predictors of Desmopressin in Nocturia Patients With Nocturnal Polyuria.In vivo (Athens, Greece)Article
- Pharmacologic management of nocturnal polyuria: a contemporary assessment of efficacy, safety, and progress toward individualized treatment.Therapeutic advances in urologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.