Zinc DeficiencyPhase 3NCT02321865
Dose Adjustment Study of NPC-02 in Patients With Zinc Deficiency
A Phase 3 study testing NPC-02 in people with Zinc Deficiency, run by Nobelpharma at 1 site in Japan.
Trial summary
The objective of this study is to check the dose control method of NPC-02 and the holding effect for the target serum zinc concentration in patients with zinc deficiency. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Zinc Deficiency
- What is being tested?
- NPC-02
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteJapan
- Study dates
- 21 Jan 2015to 24 Nov 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The serum zinc concentrations are under the nomal level before registration
- Able to taking a tablet
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, 537-8511
About this study
The objective of this study is to check the dose control method of NPC-02 and the holding effect for the target serum zinc concentration in patients with zinc deficiency.
- Conditions
- Zinc Deficiency
- Being tested
- NPC-02
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPC-02Drug
| Study group | Role | What they receive |
|---|---|---|
| NPC-02 | Experimental | Not described Receives: Drug: NPC-02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of the patients who could maintain target serum zinc concentration
Measured: approx. 12-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study start21 Jan 2015
- Primary completionNov 2015
- Study completion24 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Zinc DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobelpharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321865
- Sponsor's protocol ID
- NPC-02-5
- Status last verified
- Jul 2015
- First submitted
- 17 Dec 2014
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31392541
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Adjustment Study of NPC-02 in Patients With Zinc Deficiency
- ClinicalTrials.gov ID
- NCT02321865
- Acronym / sponsor ID
- NPC-02-5
- Conditions
- Zinc Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- NobelpharmaIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2015 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- 24 Nov 2015 (actual)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to check the dose control method of NPC-02 and the holding effect for the target serum zinc concentration in patients with zinc deficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NPC-02 | Experimental | Drug: NPC-02 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The serum zinc concentrations are under the nomal level before registration
- Able to taking a tablet
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPC-02 | Drug | NPC-02 |
Primary outcome
The ratio of the patients who could maintain target serum zinc concentration
Time frame: approx. 12-24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Derived from this study: PubMed 31392541Katayama 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NPC-02 in people with Zinc Deficiency, run by Nobelpharma at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ratio of the patients who could maintain target serum zinc concentration (time frame: approx. 12-24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02321865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.