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

Ferring

Status and phase: Completed; Phase 3

Conditions: Nocturia

Treatments: Drug: Desmopressin ODT 25 μg; Drug: Desmopressin ODT 50 μg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03051009

000131

Details and patient eligibility

About

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

Enrollment: 503 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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503 participants in 8 patient groups

Desmopressin ODT 25 μg (female previous on 25 μg)

Experimental group

Description:

Subjects received 25 μg in trial 000129.

Treatment:

Drug: Desmopressin ODT 25 μg

Desmopressin ODT 25 μg (female previously on placebo)

Experimental group

Description:

Subjects received placebo in trial 000129

Treatment:

Drug: Desmopressin ODT 25 μg

Desmopressin ODT 25 μg (female)

Experimental group

Description:

New female subjects

Treatment:

Drug: Desmopressin ODT 25 μg

Desmopressin ODT 25 μg (male previous on 25 μg)

Experimental group

Description:

Subjects received 25 μg in trial 000130

Treatment:

Drug: Desmopressin ODT 25 μg

Desmopressin ODT 50 μg (male previous on 50 μg)

Experimental group

Description:

Subjects received 50 μg in trial 000130

Treatment:

Drug: Desmopressin ODT 50 μg

Desmopressin ODT 50 μg (male previous on placebo)

Experimental group

Description:

Subjects received placebo in trial 000130

Treatment:

Drug: Desmopressin ODT 50 μg

Desmopressin ODT 25 μg (male)

Experimental group

Description:

Subjects received placebo in trial 000130

Treatment:

Drug: Desmopressin ODT 25 μg

Desmopressin ODT 50 μg (male)

Experimental group

Description:

New male subjects

Treatment:

Drug: Desmopressin ODT 50 μg