NCT01241214

Brief Summary

This study will assess the efficacy and safety of different doses of ACT-129968 in adult 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
579

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

November 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

3 months

First QC Date

November 12, 2010

Last Update Submit

May 10, 2019

Conditions

Seasonal Allergic Rhinitis

Keywords

Seasonal allergic rhinitisSARAllergic rhinitisAllergies

Outcome Measures

Primary Outcomes (1)

  • To demonstrate a change in Daytime Nasal Symptom Score while taking Dose 3 of ACT-129968 versus placebo

    Baseline to week 2

Secondary Outcomes (1)

  • To demonstrate a change in Daytime Nasal Symptom Score while taking either Dose 1, Dose 2, or Dose 4 of ACT-129968 verses placebo.

    Baseline to week 2

Study Arms (6)

Investigational drug - Dose 1

EXPERIMENTAL
Drug: ACT-129968

Investigational drug - Dose 2

EXPERIMENTAL
Drug: ACT-129968

Investigational drug - Dose 3

EXPERIMENTAL
Drug: ACT-129968

Investigational Drug - Dose 4

EXPERIMENTAL
Drug: ACT-129968

Active Matching Reference

OTHER
Drug: Cetirizine

Matching Placebo

PLACEBO COMPARATOR
Drug: ACT-129968Drug: CetirizineDrug: Placebo

Interventions

ACT-129968DRUG

ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily

Investigational drug - Dose 1Investigational drug - Dose 2Investigational drug - Dose 3Matching Placebo
CetirizineDRUG

Ceterizine administered once daily

Active Matching ReferenceMatching Placebo
PlaceboDRUG

Matching placebo administered twice daily.

Matching Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females aged 18 to 70 years.
  • Clinical history of symptomatic seasonal allergic rhinitis associated with mountain cedar pollen for the last two years.
  • Adequate exposure to mountain cedar pollen.
  • Positive skin prick test to mountain cedar allergen within 12 months of screening.
  • Sufficient nasal symptom score during a run-in period.

You may not qualify if:

  • Non-allergic rhinitis.
  • Bacterial or viral respiratory tract infection.
  • Chronic respiratory disorders.
  • Asthma requiring treatment other than inhaled short-acting Beta2-agonists.
  • Ocular infections or surgery, nasal obstruction, nasal biopsy or surgery, sinus surgery or perforation.
  • Smoking within the last year.
  • Ongoing or recent treatment for seasonal allergic rhinitis.
  • Initiation of allergen immunotherapy within 6 months of screening.

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, SeasonalRhinitis, AllergicHypersensitivity

Interventions

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

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateImmune System Diseases

Intervention Hierarchy (Ancestors)

HydroxyzinePiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sara Mangialaio, MD

    Actelion

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2010

First Posted

November 16, 2010

Study Start

November 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

May 15, 2019

Record last verified: 2019-05

Locations

US(7)