Specified Drug Use-results Survey (Long-term Use) on MINIRINMELT® OD Tablet (Nocturia)

NCT04329975 | Completed

• 1 other identifier: 000346
• Study Type: observational
• Target: 1,087
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the incidence and risk factors of desmopressin-induced hyponatremia during long-term treatment (1 year \[52 weeks\]) of MINIRINMELT orally disintegrating (OD) tablets 25μg/50μg (drug) for nocturia caused by nocturnal polyuria in men in daily clinical practice, and to confirm the compliance with proper use of this drug in clinical practice and to investigate the effectiveness of risk minimization activities.

Conditions

Nocturia Due to Nocturnal Polyuria

Keywords

Hyponatremia; Long-term treatment

Outcome Measures

Primary Outcomes (4)

• Occurrence of Hyponatremia

  Hyponatremia will be confirmed by the investigator if the serum sodium value is 130 mmol/L or less.

  1 year

• Time to Onset of Hyponatremia

  1 year

• Distribution of Serum Sodium Levels

  Number of participants with mild decrease (serum sodium 134-130 mmol/L); moderate decrease (serum sodium \<130 mmol/L) and severe decrease (serum sodium \<=125 mmol/L) in serum sodium levels will be presented.

  1 year

• Factors Affecting the Occurrence of Desmopressin-induced Hyponatremia

  To evaluate the role of the following factors in the study: adverse drug reactions (ADRs) incidence rate by background factors such as dose of MINIRINMELT 25 or 50 μg, participant age, baseline serum sodium levels, kidney function according to creatinine clearance, medical history and concomitant medications.

  1 year

Secondary Outcomes (4)

• Onset Situation of Adverse Drug Reaction/Infectious Disease

  1 year

• Onset Situation of Serious Adverse Events (SAEs)

  Up to 1 year

• Factors Affecting Safety

  1 year

• Compliance with proper use of drug

  1 year

Study Arms (1)

Participants with Nocturia

Participants with nocturia due to nocturnal polyuria treated with MINIRINMELT OD Tablet 25μg or 50μg as per daily clinical practice.

Drug: Desmopressin

Interventions

Desmopressin DRUG

Desmopressin (MINIRINMELT OD tablet) 25μg or 50μg, orally.

Also known as: MINIRINMELT

Participants with Nocturia

Eligibility Criteria

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

Study Population

Participants who received the MINIRINMELT for the first time in men with nocturia due to nocturnal polyuria, an indication for drug.

You may qualify if:

• Participants who received the MINIRINMELT for the first time in men with nocturia due to nocturnal polyuria, an indication for drug.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Survey Site (there may be other sites in this country)

Tokyo, Japan

Location

MeSH Terms

Conditions

Hyponatremia

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

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: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: May 19, 2020
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)