Study of Minirin Melt® in Adult Patients With Nocturia

NCT03089073 | Terminated

• 1 other identifier: 000208
• Study Type: observational
• Target: 835
• Locations: 1 country
• Sites: 1

Brief Summary

Observation of safety and efficacy of Minirin Melt® in adult patients with nocturia

Conditions

Nocturia

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mean number of nocturnal voids

  Calculated by 72 hour frequency volume chart (FVC)

  Baseline and treatment-related visits up to 3 months

Secondary Outcomes (1)

• Reduction from baseline in the mean number of nocturnal voids

  Baseline and treatment-related visits up to 3 months

Interventions

Desmopressin DRUG

60μg or 120μg once daily at bedtime

Also known as: Minirin Melt®

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Only patients to whom Minirin melt is prescribed as regular treatment is included in accordance with their usual practice and consistent with Korean prescribing information for Minirin melt.

You may qualify if:

• Adult aged between 19 and 65 years
• Patients having nocturia
• Decision made to prescribe Minirin Melt according to prescription information
• Willingness and ability to provide written informed consent

You may not qualify if:

• When patients have habitual or psychogenic polydipsia (resulting in a urine production exceeding 40ml/kg/24hours)
• When patients have a history of known or suspected cardiac insufficiency and other conditions requiring treatment with diuresis
• When patients have moderate and severe renal insufficiency (creatinine clearance below 50ml/min)
• When patients have known hyponatremia
• When patients have secretion Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
• When patients have hypersensitivity to the active substances or to any of the excipients

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Daegu Fatima Hospital (there may be other sites in this country)

Daegu, South Korea

Location

MeSH Terms

Conditions

Nocturia

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 24, 2017
• Study Start: July 13, 2015
• Primary Completion: October 5, 2018
• Study Completion: October 5, 2018
• Last Updated: February 5, 2021

Record last verified: 2021-02

Locations

KR (1)