Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis - Full Text View

Purpose

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."

Condition	Intervention	Phase
Nocturnal Enuresis	Drug: Desmopressin Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Double-blind, Placebo-controlled, Phase III Comparative Study With FE992026 in Children and Adolescents With Reduced Night-time Urinary Osmolarity-type Nocturnal Enuresis

Resource links provided by NLM:

MedlinePlus related topics: Bedwetting Urinary Incontinence

Drug Information available for: Desmopressin Desmopressin acetate

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

Change in the Number of Wet Nights Between Baseline and Treatment Period II [ Time Frame: Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation). ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Change in Number of Wet Nights Between Baseline and Treatment Period I [ Time Frame: Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation). ] [ Designated as safety issue: No ]
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.
Change in Number of Wet Nights Between Treatment Periods I and II [ Time Frame: Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4) ] [ Designated as safety issue: No ]
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.


Enrollment:	89
Study Start Date:	January 2010
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Drug: Desmopressin Desmopressin oral lyophilisate tablet, 120 μg or 240 μg, administered sublingually once a day 1½ hours before bedtime. Other Names: FE992026 desmopressin melt Minirin
Placebo Comparator: 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.	Drug: Placebo Placebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime.

Arms

Assigned Interventions

Experimental: 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.

Drug: Desmopressin

Desmopressin oral lyophilisate tablet, 120 μg or 240 μg, administered sublingually once a day 1½ hours before bedtime.

Other Names:

FE992026
desmopressin melt
Minirin

Placebo Comparator: 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.

Drug: Placebo

Placebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime.

Eligibility


Ages Eligible for Study:	6 Years to 15 Years (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosed nocturnal enuresis with reduced nighttime urinary osmolality
Age 6 or above but under 16 regardless of gender
Out-patient
Had 10 or more wet nights during the 14-day baseline period and at least 4 wet nights in each respective week
Deemed healthy by the investigator
Able to agree to and comply with fluid-intake restriction during the clinical trial and matters specified in the clinical trial protocol
Consent from the pediatric patient's legally acceptable representative
Demonstrate an understanding about this clinical trial after receiving an explanation corresponding to the prospective subject's intelligibility
Show no possibility of being a nursing mother or pregnant, or becoming pregnant
If under drug or medical therapy other than Desmopressin for treating nocturnal enuresis: able to discontinue such treatment

Exclusion Criteria:

Suffer from enuresis with an underlying disease
Participated in another clinical trial within six months preceding consent
Used an intranasal Desmopressin in the past
Presently undergoing a systemic antibiotic treatment, a treatment with an antidiuretic or a drug that affects urinary concentration, or a drug or medical therapy for overactive bladder
Have an anomaly or a disease that may affect the oral absorption of drug products
Hard to get cooperation from subject by school refusal, punishment or bullying
Deemed by the investigator to be inappropriate to participate in this trial
Unable to be placed on water-intake restriction starting from two hours before bedtime
Evidence of hepatic, renal, cardiac, or pulmonary dysfunction

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078753

Locations


Japan
Showa Hospital
Amagasaki, Hyogo, Japan
Shinko-Kakogawa Hospital
Kakogawa, Hyogo, Japan
Tamura Children's Clinic
Mito, Ibaraki, Japan
Shinbo Child Clinic
Yokohama, Kanagawa, Japan
Kansai Medical University Hirakata Hospital
Hirakata, Osaka, Japan
Takesue Children's Clinic
Musashino, Tokyo, Japan
Juntendo University Nerima Hospital
Nerima, Tokyo, Japan
Saitoh Pediatric Medical Clinic
Nishi-Tokyo, Tokyo, Japan
Hoashi Children's Psychological Clinic
Setagaya, Tokyo, Japan
Akita University Hospital
Akita, Japan
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
Hiroshima, Japan
Aikawa Station Clinic
Niigata, Japan
Kitano Hospital
Osaka, Japan
Saitama Childrens Medical Centre
Saitama, Japan
Shintoshin Child Clinic
Saitama, Japan

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators


Study Director:	Clinical Development Support	Ferring Pharmaceuticals

More Information


Responsible Party:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01078753 History of Changes
Other Study ID Numbers:	FE992026 CS35
Study First Received:	March 1, 2010
Results First Received:	September 27, 2011
Last Updated:	September 27, 2011
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:


Enuresis Urinary Incontinence Nocturnal Enuresis Urination Disorders Urologic Diseases Behavioral Symptoms Elimination Disorders Mental Disorders Lower Urinary Tract Symptoms	Urological Manifestations Signs and Symptoms Deamino Arginine Vasopressin Hemostatics Coagulants Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016

Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis (PNE)