Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

Summary

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.

Timeline

Start

2007-05

Primary completion

2008-02

Completion

2008-02

Outcome

Mixed primary results

registry analysis (superiority or other test); Placebo vs Desmopressin Melt 100 μg; p <0.0001; Odds Ratio (OR) 2.893 (95% CI 1.795 to 4.715); Regression, Logistic; NCT00477490 ↗

registry analysis (superiority or other test); Placebo vs Desmopressin Melt 10 μg; p = 0.9420; Odds Ratio (OR) 1.017 (95% CI 0.647 to 1.598); Regression, Logistic; NCT00477490 ↗

Publications

• Background Juul KV, Klein BM, Norgaard JP. Long-term durability of the response to desmopressin in female and male nocturia patients. Neurourol Urodyn. 2013 Apr;32(4):363-70. doi: 10.1002/nau.22306. Epub 2012 Sep 12.
• Results Weiss JP, Zinner NR, Klein BM, Norgaard JP. Desmopressin orally disintegrating tablet effectively reduces nocturia: results of a randomized, double-blind, placebo-controlled trial. Neurourol Urodyn. 2012 Apr;31(4):441-7. doi: 10.1002/nau.22243. Epub 2012 Mar 22.
• Juul KV, Malmberg A, van der Meulen E, Walle JV, Norgaard JP. Low-dose desmopressin combined with serum sodium monitoring can prevent clinically significant hyponatraemia in patients treated for nocturia. BJU Int. 2017 May;119(5):776-784. doi: 10.1111/bju.13718. Epub 2016 Dec 10.
• Bliwise DL, Holm-Larsen T, Goble S. Increases in duration of first uninterrupted sleep period are associated with improvements in PSQI-measured sleep quality. Sleep Med. 2014 Oct;15(10):1276-8. doi: 10.1016/j.sleep.2014.05.013. Epub 2014 Jun 13.
• Juul KV, Klein BM, Sandstrom R, Erichsen L, Norgaard JP. Gender difference in antidiuretic response to desmopressin. Am J Physiol Renal Physiol. 2011 May;300(5):F1116-22. doi: 10.1152/ajprenal.00741.2010. Epub 2011 Mar 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Desmopressin	Peptide	10 ug	Oral
Subject	Desmopressin	Peptide	25 ug	Oral
Subject	Desmopressin	Peptide	50 ug	Oral
Subject	Desmopressin	Peptide	100 ug	Oral

Indications

No indication recorded.