An Extension Study Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00615836
First received: January 18, 2008
Last updated: October 13, 2010
Last verified: October 2010
  Purpose

The purpose of this study is to investigate the efficacy and safety of several doses of the melt formulation of desmopressin in a broad population of adult patients with nocturia.


Condition Intervention Phase
Nocturia
Drug: lyophilisate oral of desmopressin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center Extension Study Investigating the Long Term Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Change in mean number of nocturnal voids [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects with > 33% reduction from baseline in mean number of voids [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in total sleep time [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
  • Safety of the "Melt" formulation [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]

Enrollment: 508
Study Start Date: December 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Minirin® Melt 10ug
desmopressin acetate (Minirin® Melt)
Drug: lyophilisate oral of desmopressin
10ug placed under the subject's tongue, without water once daily administration one hour before bedtime.
Other Name: Minirin® Melt
Active Comparator: Minirin® Melt 25ug
desmopressin acetate (Minirin® Melt)
Drug: lyophilisate oral of desmopressin
25ug placed under the subject's tongue, without water once daily administration one hour before bedtime.
Other Name: Minirin® Melt
Active Comparator: Minirin® Melt 50ug
desmopressin acetate (Minirin® Melt)
Drug: lyophilisate oral of desmopressin
50ug placed under the subject's tongue, without water once daily administration one hour before bedtime.
Other Name: Minirin® Melt
Active Comparator: Minirin® Melt 100ug
desmopressin acetate (Minirin® Melt)
Drug: lyophilisate oral of desmopressin
100ug placed under the subject's tongue, without water once daily administration one hour before bedtime.
Other Name: Minirin® Melt

Detailed Description:

The objective of the present study is to investigate the long-term efficacy and safety of the melt formulation of desmopressin.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent prior to the performance of any study-related activity.
  • Currently enrolled in Protocol. FE992026 CS29, entitled "A Randomized, Double Blind,Placebo Controlled, Parallel Group, Multi-Center Study with a Double Blind Extension Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults" and have completed at least Visit 3E in Part 11. Note: All subjects must be randomized into Part I1 of Protocol CS29 and have completed at least Visit 3E (Day 15) prior to rollover into this study. A subject can be enrolled into this study on the same day they complete Visit 3E.

Exclusion Criteria:

(Note: All changes are measured relative to the baseline values established in Protocol CS29)

  • Change in mean number of nocturnal voids
  • Proportion of subjects with > 33% reduction in the mean number of nocturnal voids
  • Change in the duration of the first sleep period
  • Change in duration of total sleep time
  • Change in nocturia-specific quality of life as assessed by scores on the International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) and the Nocturia Quality of Life Questionnaire (NQoL)
  • Change in quality of sleep as assessed by the global score of the Pittsburgh Sleep Quality Index (PSQI)
  • Change in overall Quality of Life as assessed by the SF-12
  • Treatment safety
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00615836

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

No publications provided by Ferring Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00615836     History of Changes
Other Study ID Numbers: FE992026 CS31
Study First Received: January 18, 2008
Last Updated: October 13, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Nocturia
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014