Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis (SAR)
This study has been completed.
Sponsor:
Actelion
Information provided by:
Actelion
ClinicalTrials.gov Identifier:
NCT01241214
First received: November 12, 2010
Last updated: January 6, 2012
Last verified: January 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Seasonal Allergic Rhinitis |
Drug: ACT-129968 Drug: Reference |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Actelion:
Primary Outcome Measures:
- To demonstrate a change in Daytime Nasal Symptom Score while taking Dose 3 of ACT-129968 versus placebo [ Time Frame: Baseline to week 2 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 579 |
| Study Start Date: | November 2010 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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: Reference
Active matching reference administered once daily & matching placebo administered twice 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: Reference
Active matching reference administered once daily & matching placebo administered twice daily.
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241214
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: | Sara Mangialaio, MD | Actelion |
More Information
No publications provided
| Responsible Party: | Sponsor, Actelion |
| ClinicalTrials.gov Identifier: | NCT01241214 History of Changes |
| Other Study ID Numbers: | AC-060B202 |
| Study First Received: | November 12, 2010 |
| Last Updated: | January 6, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Actelion:
|
Seasonal allergic rhinitis SAR Allergic rhinitis Allergies |
Additional relevant MeSH terms:
|
Rhinitis, Allergic, Seasonal Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity |
Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 21, 2013