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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01484119
First received: November 29, 2011
Last updated: March 27, 2013
Last verified: March 2013

November 29, 2011
March 27, 2013
December 2011
February 2012   (final data collection date for primary outcome measure)
The mean change in Daytime Nasal Symptom Score [ Time Frame: baseline to end of treatment period (2 weeks) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01484119 on ClinicalTrials.gov Archive Site
The mean change in other daytime/nighttime symptom scores of allergic rhinitis [ Time Frame: baseline to end of treatment period (2 weeks) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Seasonal Allergic Rhinitis
  • Drug: ACT-129968
    daily tablets
    Other Name: Setipiprant
  • Drug: Placebo
    matching placebo tablets and capsules
    Other Name: placebo
  • Drug: Cetirizine
    daily capsules
    Other Name: Cetirizine
  • Active Comparator: Investigational Drug
    ACT-129968
    Intervention: Drug: ACT-129968
  • Placebo Comparator: Comparative Drug
    matching placebo tablets and capsules
    Intervention: Drug: Placebo
  • Active Comparator: Reference Drug
    Cetirizine
    Intervention: Drug: Cetirizine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
630
March 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
12 Years to 76 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01484119
AC-060B307
No
Actelion
Actelion
Not Provided
Study Director: Michael Grabo, PhD Actelion
Actelion
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP