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NCT01241214 Clinical Trial

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

Seasonal Allergic Rhinitis Clinical Trial

— SAR  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01241214
Other study ID # AC-060B202
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2010
Est. completion date February 2011

Study information
Verified date May 2019
Source Idorsia Pharmaceuticals Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 579
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily
• ACT-129968
ACT-129968 (Dose 4) & matching placebo administered orally once daily
• Cetirizine
Ceterizine administered once daily
• Placebo
Matching placebo administered twice daily.

Locations
Country Name City State
United States Clinical Investigative Site 7905 Austin Texas
United States Clinical Investigative Site 7907 Kerrville Texas
United States Clinical Investigative Site 7903 New Braunfels Texas
United States Clinical Investigative Site 7901 San Antonio Texas
United States Clinical Investigative Site 7902 San Antonio Texas
United States Clinical Investigative Site 7904 San Antonio Texas
United States Clinical Investigative Site 7906 San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To demonstrate a change in Daytime Nasal Symptom Score while taking Dose 3 of ACT-129968 versus placebo Baseline to week 2
Secondary 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
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