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

Multi-center, Double-blind, Double-dummy, Randomized, Placebo-controlled, Active-reference, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-129968 in Adolescent, Adult & Elderly Patients With Seasonal Allergic Rhinitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01484119

Acronym

SAR

Enrollment

630

Registered

2011-12-02

Start date

2011-12-31

Completion date

2012-03-31

Last updated

2018-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal Allergic Rhinitis

Keywords

seasonal allergic rhinitis

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.

Interventions

DRUGACT-129968

daily tablets

DRUGPlacebo

matching placebo tablets and capsules

DRUGCetirizine

daily capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to 76 Years

Healthy volunteers

Inclusion criteria

* Males and females aged 12-76 years with documented clinical history of symptomatic seasonal allergic rhinitis associated with mountain cedar pollen for the last 2 years. * Evening reflective Total Nasal Symptom Score (p.m.rTNSS) at least 42 out of a maximum potential score of 84 over the 7-day run-in period, or \> or = 6 out of a maximum score of 12 on each of the last 4 consecutive days during the run-in period.

Exclusion criteria

* Non-allergic rhinitis. * Severe physical nasal obstruction. * Acute or significant chronic sinusitis. * Bacterial or viral infection of the upper or lower respiratory tract, nasal sinuses, or middle ear. * Ongoing chronic respiratory disorders. * Asthma requiring use of short-acting beta2-agonists \> 2 times a week or any asthma treatment other than inhaled short-acting beta2-agonists. * Diagnosis of aspirin or non-steroidal anti-inflammatory drug (NSAID)-induced asthma. * Nasal biopsy or surgery, sinus surgery, or perforation within the 8 weeks prior to the Screening Visit. * Ocular surgery within the 8 weeks prior to the Screening Visit. * Ocular infections (bacterial or viral) within the 4 weeks before screening. * Use of forbidden medications (prescribed or over-the-counter \[OTC\]) * Congenital or acquired severe immunodeficiency or known Human immunodeficiency virus (HIV)infection.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026