Trial Investigating the Long Term Safety and Tolerability of Desmopressin Orally Disintegrating T… (NCT03051009) | Clinical Trial Compass
CompletedPhase 3
Trial Investigating the Long Term Safety and Tolerability of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Subjects
Japan503 participantsStarted 2017-01-11
Plain-language summary
Demonstrate the safety and tolerability of desmopressin ODT during long-term treatment of subjects with nocturia due to nocturnal polyuria, for up to 1 year
Who can participate
Age range20 Years
SexALL
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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 (for subjects who participated in trials 000129 or 000130):
* Written informed consent prior to performance of any trial-related activity for the 000131 trial
* Has completed participation in trial 000129 or 000130
Exclusion Criteria (for subjects who participated in trials 000129 or 000130):
* Hyponatraemia (serum sodium level \<135 mmol/L) at Visit 7 in trial 000129 or 000130
* Withdrawal from clinical trial 000129 or 000130
Inclusion Criteria (for subjects who did not participate in trials 000129 or 000130):
* Written informed consent prior to performance of any trial-related activity
* Adult ≥20 years of age
* Nocturia symptoms present for ≥6 months prior to trial entry at Visit 1a
* Nocturnal polyuria at the end of screening period prior to Visit 1b
* Bothered by nocturia on the Hsu 5-point Likert bother scale at Visit 1a and Visit 1b
* Has given agreement about contraception during the trial
Exclusion Criteria (for subjects who did not participate in trials 000129 or 000130):
* Early withdrawal from clinical trial 000129 or 000130
* Evidence of any significant voiding dysfunction resulting in abnormally low bladder capacity at the end of the screening period prior to Visit 1b
* History or evidence of significant obstructive sleep apnoea
* History or diagnosis of any of the following urological diseases:
* Interstitial cystitis or bladder pain disorder
* In males, suspicion of moderate or severe benign prostate hyperplasia (BPH), defined as…
What they're measuring
1
The frequency and severity of adverse events
Timeframe: Up to 1 year
2
Clinically significant changes in laboratory values and vital signs