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Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis (SAR)

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ClinicalTrials.gov Identifier: NCT01241214
Recruitment Status : Completed
First Posted : November 16, 2010
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: ACT-129968 Drug: Cetirizine Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 579 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group, Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis
Study Start Date : November 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arms and Interventions
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Arm Intervention/treatment
Experimental: Investigational drug - Dose 1 Drug: ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily
Experimental: Investigational drug - Dose 2 Drug: ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily
Experimental: Investigational drug - Dose 3 Drug: ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily
Experimental: Investigational Drug - Dose 4 Drug: ACT-129968
ACT-129968 (Dose 4) & matching placebo administered orally once daily
Active Matching Reference Drug: Cetirizine
Ceterizine administered once daily
Placebo Comparator: Matching Placebo Drug: ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily

Drug: ACT-129968
ACT-129968 (Dose 4) & matching placebo administered orally once daily

Drug: Cetirizine
Ceterizine administered once daily

Drug: Placebo
Matching placebo administered twice daily.


Outcome Measures
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Primary Outcome Measures :
  1. To demonstrate a change in Daytime Nasal Symptom Score while taking Dose 3 of ACT-129968 versus placebo [ Time Frame: Baseline to week 2 ]

Secondary Outcome Measures :
  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. [ Time Frame: Baseline to week 2 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241214


Locations
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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 7901
San Antonio, Texas, United States, 78229
Clinical Investigative Site 7902
San Antonio, Texas, United States, 78229
Clinical Investigative Site 7904
San Antonio, Texas, United States, 78229
Clinical Investigative Site 7906
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
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Study Director: Sara Mangialaio, MD Actelion
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01241214    
Other Study ID Numbers: AC-060B202
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Keywords provided by Idorsia Pharmaceuticals Ltd.:
Seasonal allergic rhinitis
SAR
Allergic rhinitis
Allergies
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
 Immune System Diseases
Cetirizine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs