Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01078753
Recruitment Status : Completed
First Posted : March 2, 2010
Results First Posted : November 2, 2011
Last Update Posted : November 2, 2011
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 1, 2010
First Posted Date  ICMJE March 2, 2010
Results First Submitted Date  ICMJE September 27, 2011
Results First Posted Date  ICMJE November 2, 2011
Last Update Posted Date November 2, 2011
Study Start Date  ICMJE January 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2011)
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). ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 1, 2010)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2011)
  • 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). ]
    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) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2010)
  • Number of wet nights [ Time Frame: Between baseline and a 14-day period on the first and second weeks (period I) after treatment initiation ]
  • Number of wet nights [ Time Frame: Between treatment periods I and II ]
    Between treament period I (1st and 2nd weeks) and period II (3rd and 4th weeks)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis
Official Title  ICMJE A Double-blind, Placebo-controlled, Phase III Comparative Study With FE992026 in Children and Adolescents With Reduced Night-time Urinary Osmolarity-type Nocturnal Enuresis
Brief Summary 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."
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Nocturnal Enuresis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2010)
89
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2010)
80
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01078753
Other Study ID Numbers  ICMJE FE992026 CS35
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ferring Pharmaceuticals
Study Sponsor  ICMJE Ferring Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Development Support Ferring Pharmaceuticals
PRS Account Ferring Pharmaceuticals
Verification Date September 2011

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