Efficacy, Safety, and Tolerability Study of ACT-129968 in Patients With Seasonal Allergic Rhinitis (SAR)
This study has been completed.
Sponsor:
Actelion
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01484119
First received: November 29, 2011
Last updated: March 27, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
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, Allergic, Seasonal Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Respiratory Tract Infections 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 May 21, 2013