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

• 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)

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."

• 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

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