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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Seasonal Allergic Rhinitis | Drug: ACT-129968 Drug: Cetirizine Drug: Placebo | Phase 2 |
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 |
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. |
- To demonstrate a change in Daytime Nasal Symptom Score while taking Dose 3 of ACT-129968 versus placebo [ Time Frame: Baseline to week 2 ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |
Study Director: | Sara Mangialaio, MD | Actelion |
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 |
Seasonal allergic rhinitis SAR Allergic rhinitis Allergies |
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 |