CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 21 enrolled
Drug / intervention
C-1266-7 +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01500629
NCT01500629Early Ph 1Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial of a Topical Nasal Spray in the the Relief of Signs and Symptoms of an Acute Response to a Nasal Allergen Challenge

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.·interventional·Posted Dec 28, 2011·Updated Feb 27, 2017

In Brief

A Early Phase 1 clinical trial evaluating C-1266-7 and C-1266-6 (placebo) for Rhinitis, Allergic, Seasonal. Completed, enrolled 21 participants across 1 site.

Detailed Summary

The purpose of this study is to see if a new nasal spray can reduce the signs and symptoms of allergic rhinitis (hayfever). Subjects' participation in the study will last approximately 4 to 6 weeks, and each of three study visits during that time will last a few hours. Subjects will be required to have several tests done including allergy and breathing tests. They will be exposed to the item they are allergic to and will have small paper discs put in their noses. Subjects will also have the inside of their noses examined and will be asked questions about the level of their allergy symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRhinitis, Allergic, Seasonal
CountriesUnited States
CollaboratorsJohnson & Johnson Consumer and Personal Products Worldwide

Timeline

Early Ph 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 28, 2011
Enrollment StartJan 1, 2012
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.5 years ago

Interventions

C-1266-7device

Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.

C-1266-6 (placebo)device

Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment.