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

Last updated: September 27, 2011
Sponsor: Ferring Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Urinary Incontinence

Frequent Nighttime Urination (Nocturia)

Enuresis

Treatment

N/A

Clinical Study ID

NCT01078753
FE992026 CS35
  • Ages 6-15
  • All Genders

Study 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."

Eligibility Criteria

Inclusion

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 nightsin each respective week

  • Deemed healthy by the investigator

  • Able to agree to and comply with fluid-intake restriction during the clinical trialand 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 explanationcorresponding 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 nocturnalenuresis: able to discontinue such treatment

Exclusion

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 antidiureticor a drug that affects urinary concentration, or a drug or medical therapy foroveractive 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

Study Design

Total Participants: 89
Study Start date:
January 01, 2010
Estimated Completion Date:
September 30, 2010

Connect with a study center

  • Showa Hospital

    Amagasaki, Hyogo
    Japan

    Site Not Available

  • Shinko-Kakogawa Hospital

    Kakogawa, Hyogo
    Japan

    Site Not Available

  • Tamura Children's Clinic

    Mito, Ibaraki
    Japan

    Site Not Available

  • Shinbo Child Clinic

    Yokohama, Kanagawa
    Japan

    Site Not Available

  • Kansai Medical University Hirakata Hospital

    Hirakata, Osaka
    Japan

    Site Not Available

  • Takesue Children's Clinic

    Musashino, Tokyo
    Japan

    Site Not Available

  • Juntendo University Nerima Hospital

    Nerima, Tokyo
    Japan

    Site Not Available

  • Saitoh Pediatric Medical Clinic

    Nishi-Tokyo, Tokyo
    Japan

    Site Not Available

  • Hoashi Children's Psychological Clinic

    Setagaya, Tokyo
    Japan

    Site Not Available

  • Akita University Hospital

    Akita,
    Japan

    Site Not Available

  • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital

    Hiroshima,
    Japan

    Site Not Available

  • Aikawa Station Clinic

    Niigata,
    Japan

    Site Not Available

  • Kitano Hospital

    Osaka,
    Japan

    Site Not Available

  • Saitama Childrens Medical Centre

    Saitama,
    Japan

    Site Not Available

  • Shintoshin Child Clinic

    Saitama,
    Japan

    Site Not Available

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