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Clinical Trials in the EU / 2026-525419-16-00
Authorised Phase II

Randomized, observer-blind, placebo-controlled, four Parallel Group, Clinical Trial for exploring the Efficacy and Tolerability of two different strengths ketotifen nasal spray (Ketotifen 0.025 mcg/ml and 0.050 mcg/ml) vs sodium cromoglicate nasal spray 2% in Patients with Rhinitis

2026-525419-16-00 · tracked via the Priya Life Science EU tracker
Sponsor
Eudemus Pharmaceuticals Limited
Sponsor type
Pharmaceutical company
Therapeutic area
Otorhinolaryngologic Diseases
Decision date
16/07/2026
Enrollment target
120
Sites
Greece

Condition studied

Rhinitis

Investigational medicinal product(s)

Placebo Nasal SprayKetotifen 0.050% (0.50 mg/mL)Cromo-ratiopharm® NasensprayKetotifen 0.025% (0.25mg/mL)

Eligibility

Age group
65+ years, 0-17 years, 18-64 years
Sex
Female, Male

Primary endpoint

Change in VAS score in the patient symptom sumscore [from final visit (week 12) to baseline]

Endpoint detail

Change in VAS score in the patient symptom sumscore [from follow-up visit (week 4) to baseline], Change in iTNSS from final visit (week 12) to baseline, Change in iTNSS from follow-up visit (week 4) to baseline, Change in ARS score from final visit (week 12) to baseline, Change in ARS score from follow-up visit (week 4) to baseline

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2026-525419-16-00 on CTIS ↗ ← All trials in the EU