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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01078753
First received: March 1, 2010
Last updated: September 27, 2011
Last verified: September 2011

March 1, 2010
September 27, 2011
January 2010
September 2010   (final data collection date for primary outcome measure)
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.
Number of wet nights [ Time Frame: Between the baseline and a 14-day period on the third and fourth weeks (period II) after treatment initiation ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01078753 on ClinicalTrials.gov Archive Site
  • 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.
  • Number of wet nights [ Time Frame: Between baseline and a 14-day period on the first and second weeks (period I) after treatment initiation ] [ Designated as safety issue: No ]
  • Number of wet nights [ Time Frame: Between treatment periods I and II ] [ Designated as safety issue: No ]
    Between treament period I (1st and 2nd weeks) and period II (3rd and 4th weeks)
Not Provided
Not Provided
 
Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis
A Double-blind, Placebo-controlled, Phase III Comparative Study With FE992026 in Children and Adolescents With Reduced Night-time Urinary Osmolarity-type Nocturnal Enuresis

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."

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Nocturnal Enuresis
  • 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
  • Drug: Placebo
    Placebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime.
  • 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.
    Intervention: Drug: Desmopressin
  • 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
6 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01078753
FE992026 CS35
No
Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP