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

NCT ID: NCT03051009

Last Updated: 2018-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 503 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-11
• Study Completion Date: 2018-09-11

Brief 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

Conditions

Nocturia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Desmopressin ODT 25 μg (female previous on 25 μg)

Subjects received 25 μg in trial 000129.

Group Type: EXPERIMENTAL

Desmopressin ODT 25 μg

Intervention Type: DRUG

Desmopressin ODT 25 μg (female previously on placebo)

Subjects received placebo in trial 000129

Group Type: EXPERIMENTAL

Desmopressin ODT 25 μg

Intervention Type: DRUG

Desmopressin ODT 25 μg (female)

New female subjects

Group Type: EXPERIMENTAL

Desmopressin ODT 25 μg

Intervention Type: DRUG

Desmopressin ODT 25 μg (male previous on 25 μg)

Subjects received 25 μg in trial 000130

Group Type: EXPERIMENTAL

Desmopressin ODT 25 μg

Intervention Type: DRUG

Desmopressin ODT 50 μg (male previous on 50 μg)

Subjects received 50 μg in trial 000130

Group Type: EXPERIMENTAL

Desmopressin ODT 50 μg

Intervention Type: DRUG

Desmopressin ODT 50 μg (male previous on placebo)

Subjects received placebo in trial 000130

Group Type: EXPERIMENTAL

Desmopressin ODT 50 μg

Intervention Type: DRUG

Desmopressin ODT 25 μg (male)

Subjects received placebo in trial 000130

Group Type: EXPERIMENTAL

Desmopressin ODT 25 μg

Intervention Type: DRUG

Desmopressin ODT 50 μg (male)

New male subjects

Group Type: EXPERIMENTAL

Desmopressin ODT 50 μg

Intervention Type: DRUG

Interventions

Desmopressin ODT 25 μg

Intervention Type: DRUG

Desmopressin ODT 50 μg

Intervention Type: DRUG

Other Intervention Names

FE 992026; FE 992026

Eligibility Criteria

Inclusion Criteria

• Written informed consent prior to performance of any trial-related activity for the 000131 trial
• Has completed participation in trial 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

• Hyponatraemia (serum sodium level <135 mmol/L) at Visit 7 in trial 000129 or 000130
• Withdrawal from clinical trial 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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

Tokyo, , Japan

Countries

Japan

Other Identifiers

000131

Identifier Type: -

Identifier Source: org_study_id