Z-103 Phase III Clinical Study in patients with Taste Disorder - A placebo-controlled superiority study -

JRCT ID: jRCT2080221862

Registered date:23/07/2012

Basic Information

• Health condition(s) or Problem(s) studied: taste disorders induced by zinc-deficiency
• Date of first enrollment: 23/07/2012
• Target sample size: 260
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : Z-103
INN of investigational material : Polaprezinc
Therapeutic category code : 322 Mineral preparations
Dosage and Administration for Investigational material : Oral administration of one tablet twice a day after meal

control material(s)
Generic name etc : placebo
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Oral administration of one tablet twice a day after meal

Outcome(s)

Primary Outcome

Final overall efficacy evaluation
Filter-paper Disk Method

Secondary Outcome

Efficacy evaluation at each evaluation period
Filter-paper Disk Method

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 74age old
• Gender: Both

Include criteria

Patients diagnosed with the following three types.
1. Zinc-deficient taste disorder
2. Idiopathic taste disorder
3. Drug-induced taste disorder (with some exceptions)

Exclude criteria

1. Central nervous system disorder
2. Peripheral neuropathy
3. Intraoral defect and salivary gland disorder
4. Psychiatric disorder
5. Systemic disorders that cause taste disorder

Related Information

• Primary Sponsor: Zeria Pharmaceutical Co., Ltd.
• Secondary ID(s): JapicCTI-121907