TK-042 Phase III Clinical Study Long-term administration study in children with perennial allergic rhinitis

JRCT ID: jRCT2031240126

Registered date:29/05/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: perennial allergic rhinitis
• Date of first enrollment: 13/07/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Placebo administered orally as 1 tablet once daily for 1 week, TK-042 administered orally as 1 tablet once daily for 12 weeks.

Outcome(s)

• Primary Outcome: Safety endpoints (laboratory tests, vital signs, adverse events)

Key inclusion & exclusion criteria

• Age minimum: >= 7age old
• Age maximum: < 12age old
• Gender: Both

Include criteria

- >= 7 to < 12 years of age.
- Have positive (class >= 2) specific IgE antibodies test (e.g., CAP-RAST, AlaSTAT 3g, etc.) for antigens of perennial allergic rhinitis.

Exclude criteria

- Have concomitant nasal disorders (e.g., nasal polyps, nasal septum deviation, hypertrophic rhinitis, etc.) or infectious diseases (e.g., upper respiratory tract inflammation, sinusitis, infectious rhinitis, eye infections, etc.) to a degree that would interfere with the efficacy evaluation.
- Have non-allergic rhinitis (e.g., vasomotor, infectious, drug-induced, etc.) or history of non-allergic rhinitis.
- Have undergone coagulation (e.g., laser) or ablative surgery for the treatment of nasal symptoms within 1 year prior to obtaining consent.
- Have uncontrolled mild and moderate bronchial asthma (patients with conditions that require the use of injectable, oral, or inhaled steroid preparations), or severe bronchial asthma.
- Have a history of hypersensitivity to antihistamines, including this drug, or any ingredient of investigational drugs.
- Have severe hepatobiliary disorders.
- Have severe renal or urinary disorders.

Related Information

• Primary Sponsor: Nishiyama Kenichi