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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

630 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Investigational Drug

ACT-129968

Group Type ACTIVE_COMPARATOR

ACT-129968

Intervention Type DRUG

daily tablets

Comparative Drug

matching placebo tablets and capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matching placebo tablets and capsules

Reference Drug

Cetirizine

Group Type ACTIVE_COMPARATOR

Cetirizine

Intervention Type DRUG

daily capsules

Interventions

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ACT-129968

daily tablets

Intervention Type DRUG

Placebo

matching placebo tablets and capsules

Intervention Type DRUG

Cetirizine

daily capsules

Intervention Type DRUG

Other Intervention Names

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Setipiprant

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No