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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01368913
First Posted: June 8, 2011
Last Update Posted: June 12, 2013
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.
Collaborator:
Ferring Arzneimittel GmbH
Information provided by (Responsible Party):
Ferring Pharmaceuticals
  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:


Further study details as provided by Ferring Pharmaceuticals:

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

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

Enrollment: 138
Study Start Date: June 2011
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01368913     History of Changes
Other Study ID Numbers: 000018
First Submitted: June 7, 2011
First Posted: June 8, 2011
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


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