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

January 18, 2008
October 13, 2010
December 2007
May 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00615836 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Treatment safety [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
An Extension Study Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults
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

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Nocturia
  • 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
  • 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
  • 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
  • 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
  • Active Comparator: Minirin® Melt 10ug
    desmopressin acetate (Minirin® Melt)
    Intervention: Drug: lyophilisate oral of desmopressin
  • Active Comparator: Minirin® Melt 25ug
    desmopressin acetate (Minirin® Melt)
    Intervention: Drug: lyophilisate oral of desmopressin
  • Active Comparator: Minirin® Melt 50ug
    desmopressin acetate (Minirin® Melt)
    Intervention: Drug: lyophilisate oral of desmopressin
  • Active Comparator: Minirin® Melt 100ug
    desmopressin acetate (Minirin® Melt)
    Intervention: Drug: lyophilisate oral of desmopressin
Juul KV, Klein BM, Sandström R, Erichsen L, Nørgaard JP. Gender difference in antidiuretic response to desmopressin. Am J Physiol Renal Physiol. 2011 May;300(5):F1116-22. Epub 2011 Mar 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
508
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00615836
FE992026 CS31
Yes
Clinical Development Support, Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP