Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01940146
Other study ID # CLR_13_10
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2014
Est. completion date December 2014

Study information

Verified date May 2019
Source Sun Pharma Advanced Research Company Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will assess the efficacy and safety of SPARC1310 when compared to placebo and active control


Recruitment information / eligibility

Status Completed
Enrollment 222
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Intervention

Drug:
SPARC Placebo
Placebo
SPARC1310 I
SPARC1310 I
SPARC1310 II
SPARC1310 II
SPARC1310 III
SPARC1310 III

Locations

Country Name City State
Canada SPARC Site 1 Kingston

Sponsors (1)

Lead Sponsor Collaborator
Sun Pharma Advanced Research Company Limited

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT01171664 - Clinical Trial of STAHIST in Seasonal Allergic Rhinitis (SAR) Subjects Phase 2
Terminated NCT01337323 - Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting N/A
Completed NCT00784732 - A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber Phase 2
Completed NCT00578929 - Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients Phase 3
Completed NCT00619827 - Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract Phase 1
Completed NCT00209365 - The Role of Pollen Starch Granules in Pollen Challenge Studies in the Fraunhofer Environmental Exposure Unit N/A
Terminated NCT00223587 - Seasonal Allergic Rhinitis and Driving Ability Phase 4
Completed NCT00637455 - Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel Phase 4
Completed NCT00963599 - Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117) Phase 3
Recruiting NCT05346718 - Threshold Concentrations for Ragweed and Birch Pollen in Seasonal Allergic Rhinitis N/A
Completed NCT06126952 - Azelastine Allergen Chamber - Onset of Action Study Phase 2
Completed NCT02245360 - Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis Phase 3
Completed NCT01230619 - Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis Phase 2
Completed NCT00561717 - A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis Phase 4
Completed NCT00574210 - PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm) Phase 2
Completed NCT00420082 - A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber Phase 2
Completed NCT00405899 - Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections N/A
Completed NCT00443495 - Phase I/IIa Study on Chitin Microparticles in Subjects Suffering From Allergic Rhinitis Phase 1/Phase 2
Completed NCT03097432 - Non-interventional Study to Assess the Tolerability, the Safety Profile and the Adherence of Different Up-dosing Schemes for a Sublingual Immunotherapy Treatment N/A
Completed NCT05540717 - Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen Phase 3