Study to Assess the Absorption and Tolerability of Intranasal Ketorolac Tromethamine and to Assess the Effects of Oxymetazoline Hydrochloride and Fluticasone Propionate on the Absorption and Tolerability of Intranasal Ketorolac Tromethamine in Participants With Allergic Rhinitis

Allergic Rhinitis Clinical Trial

Official title:
Open Label, Three-Way Study to Assess the Absorption and Tolerability of Intranasal Ketorolac Tromethamine and to Assess the Effects of a Single Dose of Oxymetazoline Hydrochloride and Multiple Doses of Fluticasone Propionate on the Absorption and Tolerability of Intranasal Ketorolac Tromethamine in Participants With Allergic Rhinitis

Status Completed

Clinical Trial Summary

This was an open label, three way study in participants with symptomatic allergic rhinitis. The following 3 treatments were administered to each subject during dosing periods 1, 2 and 3, respectively:

- Treatment A: Single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on Day 1 of Period 1.

- Treatment B: Single intranasal dose of oxymetazoline hydrochloride followed by a single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.

- Treatment C: Seven days of treatment with intranasal fluticasone propionate (between Periods 2 and 3) followed by a single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on Day 1 of Period 3.

Subjects remained resident in the Clinical Unit from Day 1 until the morning of Day 2 in each period and there was a washout period of 2 to 7 days between periods. A post study medical was performed within 7 days of Period 3.

The objectives of this study were:

- To assess the pharmacokinetics (PK) of intranasal ketorolac in participants with symptomatic allergic rhinitis.

- To assess the effects of a single dose of intranasal oxymetazoline hydrochloride on the pharmacokinetics and tolerability of intranasal ketorolac in participants with symptomatic allergic rhinitis.

- To assess the effects of chronic administration of fluticasone propionate on the bioavailability and tolerability of intranasal ketorolac in participants with symptomatic allergic rhinitis.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01365650
Study type	Interventional
Source	Egalet Ltd
Contact
Status	Completed
Phase	Phase 1
Start date	December 2007
Completion date	June 2008

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05080322` - Efficacy and Safety of On-demand and Continuous Administration of Nasal Spray in the Treatment of Allergic Rhinitis	Phase 4
Recruiting	`NCT06028490` - A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis.	Phase 2
Completed	`NCT04388358` - Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation	N/A
Recruiting	`NCT04202263` - Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline	Phase 2
Completed	`NCT04078009` - Standardising Nasal Allergen Challenge in Adult With Hay Fever	N/A
Completed	`NCT03644680` - Changes in Adaptive Immune Responses and Effector Cell Responses Upon Nasal Allergen Exposure - a Pilot Study	N/A
Completed	`NCT04541004` - Adolescent Mite Allergy Safety Evaluation	Phase 3
Recruiting	`NCT05378594` - HDM and Silver Birch NAC Standardisation	N/A
Not yet recruiting	`NCT05684380` - Efficacy and Safety of MAZ-101 in the Treatment of Persistent Allergic Rhinitis (PER)	Phase 3
Not yet recruiting	`NCT01014325` - Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy	Phase 3
Completed	`NCT02943720` - ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen	Phase 2
Completed	`NCT02910401` - Clinical Response to Rhinovirus Challenge	Phase 2
Completed	`NCT02556801` - Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy	Phase 2
Not yet recruiting	`NCT02233426` - Effect of Hypertonic Solutions on Allergic Rhinitis Patients	N/A
Completed	`NCT02352168` - Airway Inflammation in Children With Allergic Rhinitis and Intervention	N/A
Completed	`NCT01918956` - PURETHAL Birch RUSH Study	Phase 4
Completed	`NCT01946035` - Alpha-Blockers in Allergic Rhinitis (MAN 01)	Phase 4
Completed	`NCT01682070` - SUBLIVAC FIX Phleum Pratense DT/DRF	Phase 2
Recruiting	`NCT01454492` - The Relationship Between Allergic Rhinitis and Geographic Tongue	N/A
Completed	`NCT01439815` - An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.