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
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: ACT-129968
Drug: Placebo
Drug: Cetirizine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • The mean change in Daytime Nasal Symptom Score [ Time Frame: baseline to end of treatment period (2 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 630
Study Start Date: December 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Investigational Drug
ACT-129968
Drug: ACT-129968
daily tablets
Other Name: Setipiprant
Placebo Comparator: Comparative Drug
matching placebo tablets and capsules
Drug: Placebo
matching placebo tablets and capsules
Other Name: placebo
Active Comparator: Reference Drug
Cetirizine
Drug: Cetirizine
daily capsules
Other Name: Cetirizine

  Eligibility

Ages Eligible for Study:   12 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484119

Locations
United States, Texas
Clinical Investigative Site 7905
Austin, Texas, United States, 78731
Clinical Investigative Site 7907
Kerrville, Texas, United States, 78028
Clinical Investigative Site 7903
New Braunfels, Texas, United States, 78130
Clinical Investigative Site 7904
San Antonio, Texas, United States, 78229
Clinical Investigative Site 7901
San Antonio, Texas, United States, 78229
Clinical Investigative Site 7906
San Antonio, Texas, United States, 78229
Clinical Investigative Site 7902
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Actelion
Investigators
Study Director: Michael Grabo, PhD Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01484119     History of Changes
Other Study ID Numbers: AC-060B307
Study First Received: November 29, 2011
Last Updated: March 27, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Actelion:
seasonal allergic rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014