Current partner codePEPTIDESDE
NCT03051009·Phase 3·INTERVENTIONAL

Trial Investigating the Long Term Safety and Tolerability of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Subjects

Status

Completed

Phase

Phase 3

Enrollment

503

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Interventions

Treatment arms and agents.

DRUG

Desmopressin ODT 25 μg

DRUG

Desmopressin ODT 50 μg

Timeline

From registration to results.

  1. First posted

    Feb 13, 2017

  2. Study start

    Jan 11, 2017

  3. Primary completion

    Sep 11, 2018

  4. Study completion

    Sep 11, 2018

  5. Results posted

    Not reported

  6. Registry updated

    Sep 17, 2018

Outcomes

What the study measures.

Primary outcomes

The frequency and severity of adverse events

Time frame · Up to 1 year

During long-term treatment

Clinically significant changes in laboratory values and vital signs

Time frame · Up to 1 year

During long-term treatment

The incidence and severity of hyponatraemia

Time frame · Up to 1 year

Measured by serum sodium levels during long-term treatment

Secondary outcomes

Change from baseline in mean number of nocturnal voids

Time frame · Week 12, 24, 40 and 52

Change from baseline in mean time to first awakening to void

Time frame · Week 12, 24, 40 and 52

Change from baseline in mean nocturnal urin volume

Time frame · Week 12, 24, 40 and 52

Change from baseline in mean Nocturnal Polyuria Index (NPI)

Time frame · Week 12, 24, 40 and 52

Change from baseline in Nocturia-Specific Quality-of-Life Questionnaire (N-QoL)

Time frame · Week 12, 24, 40 and 52

Change from baseline in Insomnia Severity Index (ISI)

Time frame · Week 12, 24, 40 and 52

Change from baseline in bother score

Time frame · Week 12, 24, 40 and 52

Assessed by the Hsu 5-point Likert bother scale

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 international prostate symptom score (IPSS) ≥8 points and: * Urinary flow \<5 mL/s or * Post-void residual volume \>150 mL * Stress urinary incontinence or mixed incontinence, where stress incontinence is the predominant component based on prior history * Chronic prostatitis/chronic pelvic pain syndrome * Surgical treatment, including transurethral resection, for BOO or BPH within the past 6 months prior to Visit 1a * Symptoms of severe over-active bladder (OAB): * Defined as an over-active bladder symptom score (OABSS) ≥12 at Visit 1a * 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 1b * Genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency or urinary incontinence at Visit 1a * Complication of cancer or a history of cancer which has not been in remission for the last 5 years at Visit 1a * Current or a history of urologic malignancies, any lower urinary tract surgery, previous pelvic irradiation, or neoplasia at Visit 1a * History of any neurological disease affecting bladder function or muscle strength at Visit 1a * Habitual or psychogenic polydipsia based on medical history at Visit 1a or 24-hour urine output of \>2.8 L based on the voiding diary at Visit 1b * Central or nephrogenic diabetes insipidus at Visit 1a * Syndrome of inappropriate antidiuretic hormone secretion at Visit 1a * Suspicion or evidence of cardiac failure at Visit 1a * Uncontrolled hypertension at Visit 1a and Visit 1b * Hyponatraemia (serum sodium level \<135 mmol/L) at Visit 1a Renal insufficiency at Visit 1a and Visit 1b * Renal insufficiency at Visit 1a and Visit 1b * Hepatic and/or biliary diseases at Visit 1a and Visit 1b * Known or suspected hypersensitivity to desmopressin ODTs or previous desmopressin treatment for nocturia at Visit 1a * In females, pregnancy, breastfeeding, or a plan to become pregnant during the period of the clinical trial. * Known alcohol or substance abuse at Visit 1a * Work or lifestyle that may interfere with regular night-time sleep at Visit 1a, e.g., shift workers * Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, or language barrier that, in the judgment of the investigator, would impair participation in the trial at Visit 1a * Use of any prohibited therapy during the trial period

Study locations

1 registered sites.

Japan. Showing up to 24 locations stored in the fast local snapshot.

Investigational site (there may be other sites in this country)

Tokyo, Japan

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Desmopressin.

Related PeptideStat pages

Put the record in context.

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