NCT01614691

Brief Summary

This study will assess safety and efficacy of SPARC1203 delivered via nasal spray in patients with allergic rhinitis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

5 months

First QC Date

June 6, 2012

Last Update Submit

May 2, 2019

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Change in Total Nasal Symptom Score (TNSS)

    Baseline and 2 weeks

Study Arms (4)

SPARC1203 low dose

EXPERIMENTAL
Drug: SPARC1203

SPARC1203 mid dose

EXPERIMENTAL
Drug: SPARC1203

SPARC1203 high dose

EXPERIMENTAL
Drug: SPARC1203

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SPARC1203DRUG

Active

SPARC1203 high doseSPARC1203 low doseSPARC1203 mid dose
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients aged 18 to 65 years (both inclusive) with history of seasonal allergic rhinitis and positive skin prick test

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SPARC Site 1

Hanover, Germany

Location

Related Publications (1)

  • 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.

    PMID: 26272281DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2012

First Posted

June 8, 2012

Study Start

June 1, 2012

Primary Completion

November 1, 2012

Study Completion

March 1, 2013

Last Updated

May 3, 2019

Record last verified: 2019-05

Locations

DE(1)