Overview

This trial is active, not recruiting.

Condition perennial allergic rhinitis
Treatments gsp 301 ns, gsp 301 placebo ns ph 3.7, gsp 301 placebo ns ph 7
Phase phase 3
Sponsor Glenmark Specialty S.A.
Start date April 2016
End date June 2017
Trial size 600 participants
Trial identifier NCT02709538, GPL/CT/2014/018/III

Summary

To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS formulations for the treatment of perennial allergic rhinitis (patients 12 years of age and older)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
gsp 301 ns
2 spray in each nostril twice daily for 52 weeks
(Placebo Comparator)
gsp 301 placebo ns ph 3.7
2 spray in each nostril twice daily for 52 weeks
(Placebo Comparator)
gsp 301 placebo ns ph 7
2 spray in each nostril twice daily for 52 weeks

Primary Outcomes

Measure
Proportion of subjects with treatment-emergent adverse events (TEAEs).
time frame: 52 weeks

Secondary Outcomes

Measure
Change from baseline in the average AM subject-reported reflective individual nasal symptoms (rTNSS)
time frame: Baseline and 52 weeks
Change from baseline in the average AM subject-reported instantaneous Total Nasal Symptom Score (iTNSS)
time frame: Baseline and 52 weeks
Change from baseline in the overall Rhinoconjunctivitis Quality of Life Questionnaire - Standardized Activities (RQLQ(S)) score
time frame: Baseline and 52 weeks

Eligibility Criteria

Male or female participants at least 12 years old.

Inclusion Criteria: 1. Aged ≥12 years and older inclusive of either sex. 2. Documented clinical history of PAR (for at least 2 years preceding the Screening Visit [Visit 1]) and exhibiting a documented positive skin prick test (wheal diameter at least 3 mm greater than negative diluent control wheal) to at least 1 allergen known to induce PAR. Documentation of a positive result within 12 months prior to the Screening Visit (Visit 1) is acceptable. Exclusion Criteria: 1. Pregnant or lactating women. 2. History of anaphylaxis and/or other severe local reaction(s) to skin testing. 3. History of positive test for HIV, Hepatitis B or Hepatitis C infection. 4. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip. 5. Subjects with an active pulmonary disorder or infection. 6. Subjects with posterior subcapsular cataracts or glaucoma

Additional Information

Official title A Double-Blind, Randomized, Parallel-Group Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Two Placebo Nasal Spray Formulations in Subjects (Aged 12 Years and Older) With Perennial Allergic Rhinitis (PAR)
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Glenmark Specialty S.A..