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 (Adult, Senior) |
| 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
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: NCT01241214
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 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
Actelion
Investigators
| Study Director: | Sara Mangialaio, MD | Actelion |
More Information
| 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 Rhinitis, Allergic Rhinitis, Allergic, Seasonal Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on September 27, 2016