A Randomized, Double-Blind, Placebo Controlled Study of NPC-02 in Patients With Zinc Deficiency

• Sponsor: Nobelpharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02337569
• Collaborator: (none)
• Enrollment: 57
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 5.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Zinc Deficiency	Drug: NPC-02; Drug: Placebos	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo Controlled Study of NPC-02 in Patients With Zinc Deficiency
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NPC-02 Oral dose	Drug: NPC-02
Placebo Comparator: Placebo Oral dose	Drug: Placebos

Outcome Measures

Primary Outcome Measures

1. The change amount of serum zinc concentration between starting and 8 weeks after dosing [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

The serum zinc concentrations are under the normal level before registration

Exclusion Criteria:

1. Heavy hepatitis

2. Malignant tumor

3. Severe heart disease, hematological disorder, kidney disease and pancreatic disease, etc.

4. The serum albumin under 2.8 g/dL

5. Patient of allergy and hyperesthesia to zinc containing medicine manufacturing (including supplement)

6. Patient who was taking a medicine including the zinc (including supplement) within 12 weeks before registration

7. Pregnant, suspected pregnant, lactating, patients who wish to have a child

8. Patient who participated in other clinical trials within 12 weeks before registration

9. Unsuitable as a target of this clinical trial judged by doctor

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Osaka Medical Center for Cancer and Cardiovascular Diseases	Osaka		Japan

Sponsors and Collaborators

• Nobelpharma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nobelpharma
• ClinicalTrials.gov Identifier: NCT02337569
• Other Study ID Numbers: NPC-02-4
• First Posted: Jan 13, 2015
• Last Update Posted: Apr 17, 2019
• Last Verified: Apr 1, 2019

Study Results

No Results Posted as of Apr 17, 2019