Efficacy, Safety, and Tolerability Study of ACT-129968 in Patients With Seasonal Allergic Rhinitis

Phase 3

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: Placebo; Drug: ACT-129968; Drug: Cetirizine

• Registration Number: NCT01484119
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Brief Summary

This study will assess the efficacy and safety of ACT-129968 in adolescent, adult and elderly patients with seasonal allergic rhinitis, due to mountain cedar pollen.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-29
• Study Start: 2011-12
• Study First Submitted QC: 2011-12-01
• Study First Posted: 2011-12-02
• Primary Completion: 2012-02
• Study Completion: 2012-03
• Disposition First Submitted: 2013-03-27
• Disposition First Submitted QC: 2013-03-27
• Disposition First Posted: 2013-04-04
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-26
• Last Update Posted: 2018-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparative Drug	Placebo	matching placebo tablets and capsules
Investigational Drug	ACT-129968	ACT-129968
Reference Drug	Cetirizine	Cetirizine

Primary Outcome Measures

Name	Time	Method
The mean change in Daytime Nasal Symptom Score	baseline to end of treatment period (2 weeks)

Secondary Outcome Measures

Name	Time	Method
The mean change in other daytime/nighttime symptom scores of allergic rhinitis	baseline to end of treatment period (2 weeks)

Trial Locations

Locations (7)

Clinical Investigative Site 7903; 🇺🇸 New Braunfels, Texas, United States

Clinical Investigative Site 7905; 🇺🇸 Austin, Texas, United States

Clinical Investigative Site 7901; 🇺🇸 San Antonio, Texas, United States

Clinical Investigative Site 7907; 🇺🇸 Kerrville, Texas, United States

Clinical Investigative Site 7906; 🇺🇸 San Antonio, Texas, United States

Clinical Investigative Site 7902; 🇺🇸 San Antonio, Texas, United States

Clinical Investigative Site 7904; 🇺🇸 San Antonio, Texas, United States