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MINRIN® Orally Disintegrating Tablet (Fast Dissolving Desmopressin) and Tablets in Treatment of Primary Nocturnal Enuresis (MELT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ferring Arzneimittel GmbH
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01368913
First received: June 7, 2011
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
  Purpose

Desmopressin in treatment of nocturnal enuresis (bedwetting).


Condition
Nocturnal Enuresis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: MINRIN® Orally Disintegrating Tablet (Fast Dissolving Desmopressin) and Tablets in Treatment of Primary Nocturnal Enuresis With Special Focus on Patient Satisfaction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Assessment of patient and parent satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of wet nights [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Assessment of drinking volume [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Assessment of urine volume [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Assessment of patient compliance [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 138
Study Start Date: June 2011
Estimated Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients treated with orally disintegrating tablet
Patients treated with tablets

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with primary nocturnal enuresis

Criteria

Inclusion Criteria:

  • Treatment of primary nocturnal enuresis within an overall therapeutical concept, eg, in cases of failure of other non-medicinal therapies or with indication of a medicinal therapy caused by nocturnal ADH deficiency
  • The patients and their parents have been informed about the study and have given their written consent for participation.

Exclusion Criteria:

  • The prescription of Minirin® tablets / Minirin® orally disintegrating tablet (fast dissolving desmopressin) is contraindicated
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368913

  Show 73 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Ferring Arzneimittel GmbH
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01368913     History of Changes
Other Study ID Numbers: 000018
Study First Received: June 7, 2011
Last Updated: April 24, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Enuresis
Nocturnal Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Deamino Arginine Vasopressin
 Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013