Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria … (NCT02905682) | Clinical Trial Compass
CompletedPhase 3
Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Female Subjects
Japan190 participantsStarted 2016-09
Plain-language summary
The purpose of this trial is to demonstrate efficacy of desmopressin ODT against placebo for the treatment of female subjects with nocturia due to nocturnal polyuria, during 12 weeks of treatment.
Who can participate
Age range20 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent prior to performance of any trial-related activity
* Woman ≥20 years of age
* Nocturia symptoms present for ≥6 months prior to trial entry at Visit 1
* ≥2 nocturnal voids at the end of screening period prior to Visit 2
* Nocturnal polyuria at the end of screening period prior to Visit 2
* Bothered by nocturia on the Hsu 5-point Likert bother scale at Visit 1 and Visit 2
* Has given agreement about contraception during the trial
Exclusion Criteria:
* Evidence of any significant voiding dysfunction resulting in abnormally low bladder capacity at the end of the screening period prior to Visit 2
* History or evidence of significant obstructive sleep apnoea
* History or diagnosis of any of the following urological diseases at Visit 1:
* Interstitial cystitis or bladder pain disorder
* Stress urinary incontinence or mixed incontinence, where stress incontinence is the predominant component based on prior history
* Chronic pelvic pain syndrome
* Surgical treatment, including transurethral resection, for bladder outlet obstruction (BOO) within the past 6 months prior to Visit 1
* Symptoms of severe over-active bladder (OAB):
* Defined as an over-active bladder symptom score (OABSS) ≥12 at Visit 1
* Defined as a mean of \>8 voids and a mean of ≥1 urgency episode per 24 hours at the end of the screening period prior to Visit 2
* Genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency …
What they're measuring
1
Change from baseline in mean number of nocturnal voids during 12 weeks of treatment