Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis
1 other identifier
interventional
222
1 country
1
Brief Summary
The study will assess the efficacy and safety of SPARC1310 when compared to placebo and active control
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2013
CompletedFirst Posted
Study publicly available on registry
September 12, 2013
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
April 11, 2016
CompletedMay 3, 2019
May 1, 2019
2 months
September 6, 2013
November 19, 2015
May 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Total Nasal Symptom Score From Baseline to Day 14.
The 4-point (0=None, 1=Mild, 2=Moderate, and 3=Severe) intensity scale was summed across multiple symptoms (nasal congestion, rhinorrhea, nasal itching, and sneezing). Thus, the TNSS scores could range from 0 to 12, with higher scores indicative of greater severity.
Baseline to Day 14
Study Arms (4)
SPARC Placebo
PLACEBO COMPARATORSPARC1310 I
EXPERIMENTALSPARC1310 II
EXPERIMENTALSPARC1310 III
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male or female participants aged 18 to 65 years with history of seasonal allergic rhinitis
- Participants able to understand and willing to sign the informed consent form
You may not qualify if:
- Anotomical deviations of the nasal septum that significantly impair ventilation or airflow
- Pregnant or nursing women
- Positive serology for infectious disease (Hepatitis B or C, HIV) at screening
- Parallel participation in another current investigational study, participation in a study within less than 30 days prior to study entry, or previous participation in this same study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SPARC Site 1
Kingston, Canada
Related Publications (1)
Ellis AK, Steacy LM, Joshi A, Bhowmik S, Raut A. Efficacy of the novel nasal steroid S0597 tested in an environmental exposure unit. Ann Allergy Asthma Immunol. 2016 Sep;117(3):310-7. doi: 10.1016/j.anai.2016.07.018.
PMID: 27613466DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Shravanti Bhowmik, MD
- Organization
- SPARC
Study Officials
- STUDY DIRECTOR
Shravanti Bhowmik, MD
Sun Pharma Advanced Research Company Limited
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2013
First Posted
September 12, 2013
Study Start
October 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
May 3, 2019
Results First Posted
April 11, 2016
Record last verified: 2019-05