A noninferiority study of NPC-25 in patients with hypozincemia

JRCT ID: jRCT2071210102

Registered date:25/12/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: hypozincemia
• Date of first enrollment: 20/01/2022
• Target sample size: 190
• Study type: Interventional

Intervention(s)

NPC-25 group:Take the drug orally once daily after a meal.
NOBELZIN group:Take the drug orally once to three times daily after meals.

Outcome(s)

• Primary Outcome: The proportion of subjects who become able to maintain the target serum zinc concentration range (80 to <200 micro g/dL) for 8 weeks at the same dose, within 24 weeks of the start of the treatment.

Secondary Outcome

(1) Time from the start of treatment to first reaching the target serum zinc concentration range (80 to <200 micro g/dL)
(2) Time from the start of treatment to first reaching the maintenance of the target serum zinc concentration range (80 to <200 micro g/dL) for 8 weeks at the same dose
(3) Changes over time in serum zinc concentrations

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who have provided written informed consent and are confirmed to meet the following criteria (1) and (2) at the time of enrollment.
(1) Patients whose serum zinc concentrations (measured at institutions) both at the time of enrollment and within 8 weeks before the start of treatment are less than 70 micro g/dL
(2) Patients weighing at least 30 kg who are capable of taking tablets orally at the time of providing informed consent, regardless of sex and inpatient or outpatient status

Exclude criteria

Patients falling under any of the following criteria at the time of enrollment will be excluded.
(1) Patients with fulminant hepatitis
(2) Patients with malignant tumors
(3) Patients with serious heart, blood, kidney or pancreatic disease, or the like
(4) Patients with serum albumin levels of less than 2.8 g/dL
(5) Patients with serum copper concentrations below the lower limit of the reference range
(6) Patients who have allergies or hypersensitivity to zinc-containing preparations (including supplements)
(7) Patients who have taken zinc-containing preparations or zinc-containing supplements that are prohibited from being used concomitantly within 12 weeks before enrollment.
(8) Patients who are or may possibly be pregnant, or wish to become pregnant during the study period
(9) Patients who participated in other clinical trials within 12 weeks before enrollment.
(10)Patients whose participation in the study is considered inappropriate by the investigator (subinvestigator).

Related Information

• Primary Sponsor: Kitamura Motohiro