NCT02337569

Brief Summary

The objective of this study is to evaluate efficacy and safety of NPC-02 in patients with Zinc Deficiency.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

January 9, 2015

Last Update Submit

April 15, 2019

Conditions

Zinc Deficiency

Outcome Measures

Primary Outcomes (1)

  • The change amount of serum zinc concentration between starting and 8 weeks after dosing

    8 weeks

Study Arms (2)

NPC-02

EXPERIMENTAL

Oral dose

Drug: NPC-02

Placebo

PLACEBO COMPARATOR

Oral dose

Drug: Placebos

Interventions

NPC-02DRUG
NPC-02
PlacebosDRUG
Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The serum zinc concentrations are under the normal level before registration

You may not qualify if:

  • Heavy hepatitis
  • Malignant tumor
  • Severe heart disease, hematological disorder, kidney disease and pancreatic disease, etc.
  • The serum albumin under 2.8 g/dL
  • Patient of allergy and hyperesthesia to zinc containing medicine manufacturing (including supplement)
  • Patient who was taking a medicine including the zinc (including supplement) within 12 weeks before registration
  • Pregnant, suspected pregnant, lactating, patients who wish to have a child
  • Patient who participated in other clinical trials within 12 weeks before registration
  • Unsuitable as a target of this clinical trial judged by doctor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka, Japan

Location

Related Publications (1)

  • Katayama K, Hosui A, Sakai Y, Itou M, Matsuzaki Y, Takamori Y, Hosho K, Tsuru T, Takikawa Y, Michitaka K, Ogawa E, Miyoshi Y, Ito T, Ida S, Hamada I, Miyoshi K, Kodama H, Takehara T. Effects of Zinc Acetate on Serum Zinc Concentrations in Chronic Liver Diseases: a Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial and a Dose Adjustment Trial. Biol Trace Elem Res. 2020 May;195(1):71-81. doi: 10.1007/s12011-019-01851-y. Epub 2019 Aug 7.

    PMID: 31392541DERIVED

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2015

First Posted

January 13, 2015

Study Start

January 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

JP(1)