Back to resultsSafety and Efficacy of SPARC1203 in Allergic Rhinitis
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
SPARC1203
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis
Eligibility Criteria
Inclusion Criteria:
- Male and female patients aged 18 to 65 years (both inclusive) with history of seasonal allergic rhinitis and positive skin prick test
Exclusion Criteria:
- History or presence of perennial allergic rhinitis
- Upper or lower respiratory tract infection 2 weeks before Visit 2
- Significant pulmonary disease other than allergic rhinitis or mild asthma controlled by beta-2-agonists alone
- Immunizations or vaccinations within 4 weeks prior to Visit 1
Sites / Locations
- SPARC Site 1
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
SPARC1203 low dose
SPARC1203 mid dose
SPARC1203 high dose
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in Total Nasal Symptom Score (TNSS)
Secondary Outcome Measures
Full Information
NCT ID
NCT01614691
First Posted
June 6, 2012
Last Updated
May 2, 2019
Sponsor
Sun Pharma Advanced Research Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT01614691
Brief Title
Safety and Efficacy of SPARC1203 in Allergic Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharma Advanced Research Company Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will assess safety and efficacy of SPARC1203 delivered via nasal spray in patients with allergic rhinitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPARC1203 low dose
Arm Type
Experimental
Arm Title
SPARC1203 mid dose
Arm Type
Experimental
Arm Title
SPARC1203 high dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SPARC1203
Intervention Description
Active
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in Total Nasal Symptom Score (TNSS)
Time Frame
Baseline and 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients aged 18 to 65 years (both inclusive) with history of seasonal allergic rhinitis and positive skin prick test
Exclusion Criteria:
History or presence of perennial allergic rhinitis
Upper or lower respiratory tract infection 2 weeks before Visit 2
Significant pulmonary disease other than allergic rhinitis or mild asthma controlled by beta-2-agonists alone
Immunizations or vaccinations within 4 weeks prior to Visit 1
Facility Information:
Facility Name
SPARC Site 1
City
Hannover
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
26272281
Citation
Badorrek P, Hohlfeld JM, Krug N, Joshi A, Raut A. Efficacy and safety of a novel nasal steroid, S0597, in patients with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2015 Oct;115(4):325-329.e1. doi: 10.1016/j.anai.2015.07.016. Epub 2015 Aug 11.
Results Reference
derived
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Safety and Efficacy of SPARC1203 in Allergic Rhinitis
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