NCT03051009 is a Phase 3 clinical trial of Desmopressin ODT 25 μg in Nocturia, sponsored by Ferring Pharmaceuticals.

Who is sponsoring NCT03051009?

NCT03051009 is sponsored by Ferring Pharmaceuticals.

What drugs are being tested in NCT03051009?

Interventions in NCT03051009: Desmopressin ODT 25 μg, Desmopressin ODT 50 μg.

Is NCT03051009 still recruiting?

NCT03051009 is currently completed. Last updated 17 September 2018.

Last reviewed 2018-09-17 · How we verify

NCT03051009

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Trial Investigating the Long Term Safety and Tolerability of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Subjects

Completed Phase 3 Last updated 17 September 2018

What this trial tests

Phase 3 trial testing Desmopressin ODT 25 μg in Nocturia in 503 participants. Completed in 11 September 2018.

Timeline

11 January 2017

Primary endpoint
11 September 2018

11 September 2018

Quick facts

Lead sponsor	Ferring Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	503
Start date	11 January 2017
Primary completion	11 September 2018
Estimated completion	11 September 2018
Sites	1 location across Japan

Drugs / interventions tested

Desmopressin ODT 25 μg — full drug profile →
Desmopressin ODT 50 μg — full drug profile →

Conditions studied

Nocturia — all drugs for Nocturia →

Sponsor

Ferring Pharmaceuticals — full company profile →

Who can join

20 and older, any sex, with Nocturia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Demonstrate the safety and tolerability of desmopressin ODT during long-term treatment of subjects with nocturia due to nocturnal polyuria, for up to 1 year

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Pharmacologic management of nocturnal polyuria: a contemporary assessment of efficacy, safety, and progress toward individualized treatment.
Monaghan TF, Weiss JP, Everaert K, Wein AJ. · · 2021 · cited 6× · PMID 33796148 · DOI 10.1177/1756287220988438
Achieving clinically meaningful quality of life benefits in nocturia takes time: Results from a long-term, multicenter phase 3 study of desmopressin in Japanese patients.
Juul KV, Andersson FL, Yamaguchi O. · · 2021 · cited 2× · PMID 32914581 · DOI 10.1111/luts.12347

Verify or expand the search:

Other recruiting trials for Nocturia

Currently open trials in the same condition.

NCT06754189 — Safety and Performance of UCon Patch Electrode · NA · recruiting
NCT06866834 — Examination of the Effect of Nocturia on Pelvic Floor Symptoms, Sleep Parameters and Quality of Life in Women with Urina · recruiting
NCT06091566 — Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) · NA · recruiting
NCT05874375 — UCon Treatment of Overactive Bladder (OAB) in Males · NA · recruiting
NCT05604222 — Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women · Phase 4 · recruiting

Other Ferring Pharmaceuticals trials

Trials by the same sponsor.

NCT07152730 — A Study to Measure Pharmacokinetic (PK) Concentrations of Gonadotropin-Releasing Hormone Delivered by the OmniPod Pump · Phase 1 · withdrawn
NCT07029451 — To Investigate REKOVELLE in Chinese Women Undergoing Assisted Reproductive Technologies: Effectiveness, Safety, and Patt · recruiting
NCT06668493 — Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis · Phase 1, PHASE2 · recruiting
NCT06545955 — A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in · Phase 3 · recruiting
NCT06510374 — Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Can · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03051009 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ferring Pharmaceuticals
Last refreshed: 17 September 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03051009.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing