New allergy pill shows promise for kids in Long-Term trial
NCT ID NCT01900054
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested the long-term safety and effectiveness of TAU-284 (bepotastine besilate) in 58 children aged 7 to 15 with perennial allergic rhinitis (year-round nasal allergies). Over 12 weeks, researchers tracked side effects and changes in sneezing, runny nose, and congestion. The goal was to see if the drug is safe and helpful for long-term use in kids.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bepotastine besilate (antihistamine tablet)
- What this could lead to
- If successful, this could confirm a safe and effective long-term allergy medication option for children with year-round nasal allergies.
- What could go wrong
- This is a small, completed phase 3 trial with only 58 participants, so results may not apply to all children. As with any drug, side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
58 people
The number who actually took part.
- Start date
-
Jun 2013
- Finished
-
Nov 2013
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
7 to 15 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients aged between 7 and 15 years * Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria * Patients with a mean total score for the three major nasal symptoms \[sneezing, rhinorrhea, and nasal congestion\] of at least 3 on the basis of symptoms recorded in the nasal allergy diary during the observation period etc. Exclusion Criteria: * Patients with vasomotor rhinitis or eosinophilic rhinitis * Patients who have concurrent nasal disease that may affect the efficacy of TAU-284 * Patients with a history of any of the nasal surgical procedures * Patients with current or previous history of drug allergy * Patients who concurrently have renal function abnormalities that may cause safety problems etc.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Reserch site
Kanagawa, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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