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

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ClinicalTrials.gov Identifier: NCT01368913
Recruitment Status : Completed
First Posted : June 8, 2011
Last Update Posted : June 12, 2013
Sponsor:
Collaborator:
Ferring Arzneimittel GmbH
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
Desmopressin in treatment of nocturnal enuresis (bedwetting).

Condition or disease
Nocturnal Enuresis

Study Type : Observational
Actual Enrollment : 138 participants
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
Study Start Date : June 2011
Primary Completion Date : March 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Patients treated with orally disintegrating tablet
Patients treated with tablets



Primary Outcome Measures :
  1. Assessment of patient and parent satisfaction [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Number of wet nights [ Time Frame: 3 months ]
  2. Assessment of drinking volume [ Time Frame: 3 months ]
  3. Assessment of urine volume [ Time Frame: 3 months ]
  4. Assessment of patient compliance [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368913


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

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01368913     History of Changes
Other Study ID Numbers: 000018
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: June 12, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Enuresis
Urinary Incontinence
Nocturnal Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs