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This is multi-center, randomized, placebo-controlled, parallel-group, double-blind, dose-escalating clinical trial designed to assess the efficacy and safety of desmopressin orally lyophilisate for the treatment of nocturnal enuresis "with decreased nighttime urinary osmolality."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desmopressin | Experimental | During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II. |
|
| Placebo | Placebo Comparator | Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desmopressin | Drug | Desmopressin oral lyophilisate tablet, 120 μg or 240 μg, administered sublingually once a day 1½ hours before bedtime. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Number of Wet Nights Between Baseline and Treatment Period II | The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period II. | Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Wet Nights Between Baseline and Treatment Period I | The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period I. | Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akita University Hospital | Akita | Akita | Japan | |||
| Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40728007 | Derived | Hahn D, Stewart F, Raman G. Desmopressin for nocturnal enuresis in children. Cochrane Database Syst Rev. 2025 Jul 29;7(7):CD002112. doi: 10.1002/14651858.CD002112.pub2. |
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174 subjects consented and entered the 14-day screening period during which Baseline characteristics regarding enuretic episodes were established. Eligible patients who met the criterion were randomized 1:1 to receive either desmopressin or matching placebo.
Randomization was stratified by gender, age and number of wet nights at Baseline.
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| ID | Title | Description |
|---|---|---|
| FG000 | Desmopressin | During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II. |
| FG001 | Placebo | Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period I |
| ||||||||||||||||
| Treatment Period II |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Desmopressin | During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Number of Wet Nights Between Baseline and Treatment Period II | The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period II. | The Full Analysis Set (FAS) included all participants who received at least one dose of study treatment, satisfied all the major eligibility criteria and for whom efficacy data was obtained. | Posted | Least Squares Mean | 95% Confidence Interval | wet nights | Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation). |
|
4 weeks (periods I + II)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Desmopressin | During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Empyema | Infections and infestations | MedDRA version 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
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| ID | Term |
|---|---|
| D053206 | Nocturnal Enuresis |
| ID | Term |
|---|---|
| D004775 | Enuresis |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D003894 | Deamino Arginine Vasopressin |
| ID | Term |
|---|---|
| D001127 | Arginine Vasopressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
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| Placebo | Drug | Placebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime. |
|
| Change in Number of Wet Nights Between Treatment Periods I and II | The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Treatment Period I minus the number of wet nights during the 14-day Treatment Period II. | Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4) |
| Hiroshima |
| Hiroshima |
| Japan |
| Showa Hospital | Amagasaki | Hyōgo | Japan |
| Shinko-Kakogawa Hospital | Kakogawa | Hyōgo | Japan |
| Tamura Children's Clinic | Mito | Ibaraki | Japan |
| Shinbo Child Clinic | Yokohama | Kanagawa | Japan |
| Aikawa Station Clinic | Niigata | Niigata | Japan |
| Kansai Medical University Hirakata Hospital | Hirakata | Osaka | Japan |
| Kitano Hospital | Osaka | Osaka | Japan |
| Saitama Childrens Medical Centre | Saitama | Saitama | Japan |
| Shintoshin Child Clinic | Saitama | Saitama | Japan |
| Takesue Children's Clinic | Musashino | Tokyo | Japan |
| Juntendo University Nerima Hospital | Nerima City | Tokyo | Japan |
| Saitoh Pediatric Medical Clinic | Nishitōkyō | Tokyo | Japan |
| Hoashi Children's Psychological Clinic | Setagaya City | Tokyo | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Placebo | Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m˄2 |
|
| Number of Wet Nights during Baseline | Number of Wet Nights recorded during the 14-day Baseline period. | Mean | Standard Deviation | days |
|
| Number of Wet Nights during Baseline by stratification criteria | The number of wet nights recorded during the 14-day Baseline period is reported for each of the stratification categories. | Number | participants |
|
| Prior treatment of Nocturnal Enuresis with Drugs | Number | participants |
|
| Prior treatment of Nocturnal Enuresis with Therapy | Therapies for treatment of Nocturnal Enuresis might include life-skill guidance, bladder control training, psychotherapy, or behaviour conditioning therapy. | Number | participants |
|
| OG001 | Placebo | Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group. |
|
|
|
| Secondary | Change in Number of Wet Nights Between Baseline and Treatment Period I | The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period I. | The Full analysis set. | Posted | Least Squares Mean | 95% Confidence Interval | wet nights | Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation). |
|
|
|
|
| Secondary | Change in Number of Wet Nights Between Treatment Periods I and II | The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Treatment Period I minus the number of wet nights during the 14-day Treatment Period II. | The full analysis set. | Posted | Least Squares Mean | 95% Confidence Interval | wet nights | Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4) |
|
|
|
|
| 0 |
| 45 |
| 18 |
| 45 |
| EG001 | Placebo | Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group. | 0 | 44 | 14 | 44 |
| Nasopharyngitis | Infections and infestations | MedDRA version 13.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA version 13.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Lip ulceration | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Dyshidrosis | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Skin papilloma | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA version 13.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA version 13.1 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA version 13.1 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |
| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |