NCT00574379|CompletedPhase 2

Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SAR

A Multi-Center Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo Given Orally in The Treatment of the Symptoms of Seasonal Allergic Rhino-Conjunctivitis With Allergy to Mountain Cedar Pollen

Faes Farma, S.A.ClinicalTrials.gov

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2 other identifiers

BILA 2607/RAECTFZ07001

Study Type

interventional

Target

805

Locations

1 country

Sites

Timeline

RegisteredDec 2007

StartedDec 2007

CompletionMar 2008

Brief Summary

Evaluate the relative efficacy of four dosing regimens of bilastine tablets (given either once or twice per day) versus placebo in patients with Seasonal Allergic Rhinitis (SAR) in the Mountain Cedar season in south Texas and Oklahoma based on the mean change from baseline in Reflective Total Nasal Symptom Scores (TNSS) assessed over 14 days of treatment.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

805

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Dec 2007

Shorter than P25 for phase_2

Geographic Reach

1 country

13 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 months study duration

Study Start

First participant enrolled

December 1, 2007

Completed

13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2007

Completed

3 days until next milestone

First Posted

Study publicly available on registry

December 17, 2007

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed

Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

December 14, 2007

Last Update Submit

February 13, 2019

Conditions

Seasonal Allergic Rhinitis Hay Fever Allergic Conjunctivitis Hypersensitivity

Keywords

Allergic RhinitisMountain Cedar PollenPollen AllergyRhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

Change in nasal symptom scores
14 days

Secondary Outcomes (1)

Change in ocular symptom scores and quality of life scores; standard safety assessments
14 days

Study Arms (5)

1

EXPERIMENTAL

Bilastine 20mg once per day

Drug: Bilastine

2

EXPERIMENTAL

Bilastine 20mg twice per day

Drug: Bilastine

3

EXPERIMENTAL

Bilastine 10mg once per day

Drug: Bilastine

4

EXPERIMENTAL

Bilastine 10mg twice per day

Drug: Bilastine

5

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BilastineDRUG

Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets

1234

PlaceboDRUG

Placebo tablets twice daily for 14 days

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

clinical history of Seasonal Allergic Rhinoconjunctivitis with seasonal onset and offset of nasal allergy symptoms
documentation of a positive skin test within one year of screening to Mountain Cedar allergen

You may not qualify if:

significant medical condition
significant nasal abnormality
significant cardiac condition
recent infection
use of other allergy medication during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Faes Farma, S.A.lead
Merck Sharp & Dohme LLCcollaborator
Allied Research Internationalcollaborator

Study Sites (13)

Oklahoma Allergy and Asthma Clinic

Oklahoma City, Oklahoma, 73104, United States

Location

MetaClin Research Inc.

Austin, Texas, 78704, United States

Location

Austin Clinical Research

Austin, Texas, 78750, United States

Location

Lovelace Scientific Resources

Austin, Texas, 78759, United States

Location

Kerrville Research Associates

Kerrville, Texas, 78028-6071, United States

Location

Biogenics Research Institute