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

Primary Purpose

Nocturia

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Desmopressin ODT 25 μg
Desmopressin ODT 50 μg
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Desmopressin ODT 25 μg (female previous on 25 μg)

Desmopressin ODT 25 μg (female previously on placebo)

Desmopressin ODT 25 μg (female)

Desmopressin ODT 25 μg (male previous on 25 μg)

Desmopressin ODT 50 μg (male previous on 50 μg)

Desmopressin ODT 50 μg (male previous on placebo)

Desmopressin ODT 25 μg (male)

Desmopressin ODT 50 μg (male)

Arm Description

Subjects received 25 μg in trial 000129.

Subjects received placebo in trial 000129

New female subjects

Subjects received 25 μg in trial 000130

Subjects received 50 μg in trial 000130

Subjects received placebo in trial 000130

Subjects received placebo in trial 000130

New male subjects

Outcomes

Primary Outcome Measures

The frequency and severity of adverse events
During long-term treatment
Clinically significant changes in laboratory values and vital signs
During long-term treatment
The incidence and severity of hyponatraemia
Measured by serum sodium levels during long-term treatment

Secondary Outcome Measures

Change from baseline in mean number of nocturnal voids
Change from baseline in mean time to first awakening to void
Change from baseline in mean nocturnal urin volume
Change from baseline in mean Nocturnal Polyuria Index (NPI)
Change from baseline in Nocturia-Specific Quality-of-Life Questionnaire (N-QoL)
Change from baseline in Insomnia Severity Index (ISI)
Change from baseline in bother score
Assessed by the Hsu 5-point Likert bother scale

Full Information

First Posted
February 9, 2017
Last Updated
September 14, 2018
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03051009
Brief Title
Trial Investigating the Long Term Safety and Tolerability of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Subjects
Official Title
A Multi-Centre Trial Investigating the Long Term Safety and Tolerability of Desmopressin (FE 992026) Orally Disintegrating Tablets for the Treatment of Nocturia Due to Nocturnal Polyuria in Japanese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 11, 2017 (Actual)
Primary Completion Date
September 11, 2018 (Actual)
Study Completion Date
September 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The trial is designed as partly an extension trial for subjects completing trial 000129 (female subjects) and 000130 (male subjects) and partly as a trial for new female and male subjects.
Masking
ParticipantInvestigator
Masking Description
One dose level (25 μg desmopressin OCD) is included for female subjects and will be open-labelled for all female subjects. Two different dose levels (25 μg desmopressin and 50 μg desmopressin ODT are included for male subjects in a double-blinded manner. Male subjects continuing from trial 000130 will continue their randomised treatment and subjects who received placebo will be randomised to one of the 2 dose levels (25 μg desmopressin or 50 μg desmopressin ODT). New male subjects will be allocated to receive 50 μg desmopressin ODT in an open-labelled manner.
Allocation
Randomized
Enrollment
503 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desmopressin ODT 25 μg (female previous on 25 μg)
Arm Type
Experimental
Arm Description
Subjects received 25 μg in trial 000129.
Arm Title
Desmopressin ODT 25 μg (female previously on placebo)
Arm Type
Experimental
Arm Description
Subjects received placebo in trial 000129
Arm Title
Desmopressin ODT 25 μg (female)
Arm Type
Experimental
Arm Description
New female subjects
Arm Title
Desmopressin ODT 25 μg (male previous on 25 μg)
Arm Type
Experimental
Arm Description
Subjects received 25 μg in trial 000130
Arm Title
Desmopressin ODT 50 μg (male previous on 50 μg)
Arm Type
Experimental
Arm Description
Subjects received 50 μg in trial 000130
Arm Title
Desmopressin ODT 50 μg (male previous on placebo)
Arm Type
Experimental
Arm Description
Subjects received placebo in trial 000130
Arm Title
Desmopressin ODT 25 μg (male)
Arm Type
Experimental
Arm Description
Subjects received placebo in trial 000130
Arm Title
Desmopressin ODT 50 μg (male)
Arm Type
Experimental
Arm Description
New male subjects
Intervention Type
Drug
Intervention Name(s)
Desmopressin ODT 25 μg
Other Intervention Name(s)
FE 992026
Intervention Type
Drug
Intervention Name(s)
Desmopressin ODT 50 μg
Other Intervention Name(s)
FE 992026
Primary Outcome Measure Information:
Title
The frequency and severity of adverse events
Description
During long-term treatment
Time Frame
Up to 1 year
Title
Clinically significant changes in laboratory values and vital signs
Description
During long-term treatment
Time Frame
Up to 1 year
Title
The incidence and severity of hyponatraemia
Description
Measured by serum sodium levels during long-term treatment
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Change from baseline in mean number of nocturnal voids
Time Frame
Week 12, 24, 40 and 52
Title
Change from baseline in mean time to first awakening to void
Time Frame
Week 12, 24, 40 and 52
Title
Change from baseline in mean nocturnal urin volume
Time Frame
Week 12, 24, 40 and 52
Title
Change from baseline in mean Nocturnal Polyuria Index (NPI)
Time Frame
Week 12, 24, 40 and 52
Title
Change from baseline in Nocturia-Specific Quality-of-Life Questionnaire (N-QoL)
Time Frame
Week 12, 24, 40 and 52
Title
Change from baseline in Insomnia Severity Index (ISI)
Time Frame
Week 12, 24, 40 and 52
Title
Change from baseline in bother score
Description
Assessed by the Hsu 5-point Likert bother scale
Time Frame
Week 12, 24, 40 and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Investigational site (there may be other sites in this country)
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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