NCT01484119

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
630

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

7 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

First Submitted

Initial submission to the registry

November 29, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

2 months

First QC Date

November 29, 2011

Last Update Submit

September 26, 2018

Conditions

Seasonal Allergic Rhinitis

Keywords

seasonal allergic rhinitis

Outcome Measures

Primary Outcomes (1)

  • The mean change in Daytime Nasal Symptom Score

    baseline to end of treatment period (2 weeks)

Secondary Outcomes (1)

  • The mean change in other daytime/nighttime symptom scores of allergic rhinitis

    baseline to end of treatment period (2 weeks)

Study Arms (3)

Investigational Drug

ACTIVE COMPARATOR

ACT-129968

Drug: ACT-129968

Comparative Drug

PLACEBO COMPARATOR

matching placebo tablets and capsules

Drug: Placebo

Reference Drug

ACTIVE COMPARATOR

Cetirizine

Drug: Cetirizine

Interventions

ACT-129968DRUG

daily tablets

Also known as: Setipiprant
Investigational Drug
PlaceboDRUG

matching placebo tablets and capsules

Comparative Drug
CetirizineDRUG

daily capsules

Reference Drug

Eligibility Criteria

Age12 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Clinical Investigative Site 7905

Austin, Texas, 78731, United States

Location

Clinical Investigative Site 7907

Kerrville, Texas, 78028, United States

Location

Clinical Investigative Site 7903

New Braunfels, Texas, 78130, United States

Location

Clinical Investigative Site 7901

San Antonio, Texas, 78229, United States

Location

Clinical Investigative Site 7902

San Antonio, Texas, 78229, United States

Location

Clinical Investigative Site 7904

San Antonio, Texas, 78229, United States

Location

Clinical Investigative Site 7906

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • Ratner P, Andrews CP, Hampel FC, Martin B, Mohar DE, Bourrelly D, Danaietash P, Mangialaio S, Dingemanse J, Hmissi A, van Bavel J. Efficacy and safety of setipiprant in seasonal allergic rhinitis: results from Phase 2 and Phase 3 randomized, double-blind, placebo- and active-referenced studies. Allergy Asthma Clin Immunol. 2017 Apr 4;13:18. doi: 10.1186/s13223-017-0183-z. eCollection 2017.

    PMID: 28392807DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

2-(2-(1-naphthoyl)-8-fluoro-3,4-dihydro-1H-pyrido(4,3-b)indol-5(2H)-yl)acetic acidCetirizine

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

HydroxyzinePiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Michael Grabo, PhD

    Actelion

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2011

First Posted

December 2, 2011

Study Start

December 1, 2011

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

September 28, 2018

Record last verified: 2018-09

Locations

US(7)