Phase 2
N=222
Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01940146 ↗Enrolled (actual)
222
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Change in Total Nasal Symptom Score From Baseline to Day 14. — -2.70; -4.05; -4.72; -4.05 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SPARC Placebo (Drug); SPARC1310 I (Drug); SPARC1310 II (Drug); SPARC1310 III (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sun Pharma Advanced Research Company Limited
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Nasal Symptom Score From Baseline to Day 14. |
-2.70; -4.05; -4.72; -4.05 | — |
Summary
The study will assess the efficacy and safety of SPARC1310 when compared to placebo and active control
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01940146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.