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Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
SPARC Placebo
SPARC1310 I
SPARC1310 II
SPARC1310 III
Sponsored by
Sun Pharma Advanced Research Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • SPARC Site 1

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

SPARC Placebo

SPARC1310 I

SPARC1310 II

SPARC1310 III

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 6, 2013
Last Updated
May 2, 2019
Sponsor
Sun Pharma Advanced Research Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01940146
Brief Title
Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis
Official Title
Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (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
The study will assess the efficacy and safety of SPARC1310 when compared to placebo and active control

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPARC Placebo
Arm Type
Placebo Comparator
Arm Title
SPARC1310 I
Arm Type
Experimental
Arm Title
SPARC1310 II
Arm Type
Experimental
Arm Title
SPARC1310 III
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SPARC Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
SPARC1310 I
Intervention Description
SPARC1310 I
Intervention Type
Drug
Intervention Name(s)
SPARC1310 II
Intervention Description
SPARC1310 II
Intervention Type
Drug
Intervention Name(s)
SPARC1310 III
Intervention Description
SPARC1310 III
Primary Outcome Measure Information:
Title
Change in Total Nasal Symptom Score From Baseline to Day 14.
Description
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.
Time Frame
Baseline to Day 14

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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shravanti Bhowmik, MD
Organizational Affiliation
Sun Pharma Advanced Research Company Limited
Official's Role
Study Director
Facility Information:
Facility Name
SPARC Site 1
City
Kingston
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27613466
Citation
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.
Results Reference
derived

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Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis

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