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5-mg Desloratadine

Phase 3

Allergic Rhinitis | Small molecule | Respiratory |Organon & Co.|Last Updated: May 20, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment716

FDA Designations

No designations recorded

Clinical trial landscape

5-mg Desloratadine · 2 trials · 3 indications

Phase 3 2
NCT00405964Study for the Treatment of Persistent Allergic Rhinitis With Desloratadine (Study P04684)Allergic Rhinitis
COMPLETED716 Analytics
NCT00406783Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683)Rhinitis, Allergic, Seasonal
COMPLETED547 Analytics
PHASE3COMPLETED
Study for the Treatment of Persistent Allergic Rhinitis With Desloratadine (Study P04684)
Allergic RhinitisUnlock trial analytics
PHASE3COMPLETED
Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683)
Rhinitis, Allergic, SeasonalUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Participant's AM/PM PRIOR Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment
Baseline and Days 1-29

AM/PM PRIOR (the participant's status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 29. AM/PM is the average of separate morning (AM) and evening (PM) evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.

The Change From Baseline in the 12-hour AM/PM-PRIOR (Reflective) Total 5 Symptom Score (T5SS) From Subject Daily Diaries Averaged Over Treatment Days 1 to 15
15 days

AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe).

Secondary Endpoints

Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days of Treatment
Baseline and Day 29
Change From Baseline in Participant's AM/PM PRIOR T5SS Over Days 1 to 85 of Treatment
Baseline and Days 1-85
Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit
15 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
5-mg Desloratadine tabletEXPERIMENTAL -
Placebo tabletPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
5-mg DesloratadineDRUG5-mg Desloratadine tablet, once daily for 12 weeks
Placebo tabletDRUGPlacebo tablet, once daily for 12 weeks
PlaceboDRUGPlacebo tablet, once daily for 15 days
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * For this study, the diagnosis of persistent allergic rhinitis (PER) is not based solely on the current episode of allergic rhinitis (AR). Subjects must have at least a 2 year history of AR consistent with PER (defined as symptoms of allergic rhinitis present more than four day...

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Competitive Landscape -Allergic Rhinitis 4 trials

Frequently asked questions about 5-mg Desloratadine

What is 5-mg Desloratadine used for?

5-mg Desloratadine is used for the treatment of allergic rhinitis, including seasonal and perennial forms. It is being developed by Organon & Co. for respiratory conditions. The drug is currently in Phase 3 clinical development and is intended for patients aged 12 years and older.

What does 5-mg Desloratadine target?

5-mg Desloratadine is a small molecule antihistamine that works by blocking the effects of histamine, a substance in the body that causes allergic symptoms. It is being studied for its ability to relieve symptoms of allergic rhinitis, such as sneezing, runny nose, and nasal congestion.

Who makes 5-mg Desloratadine?

5-mg Desloratadine is being developed by Organon & Co., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol OGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of allergic rhinitis.

What phase is 5-mg Desloratadine in?

5-mg Desloratadine is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing clinical program includes completed Phase 3 trials that have evaluated the drug in patients with allergic rhinitis.

What clinical trials is 5-mg Desloratadine in?

5-mg Desloratadine has been studied in two completed Phase 3 clinical trials. The first trial, NCT00405964, enrolled 716 patients with persistent allergic rhinitis. The second trial, NCT00406783, enrolled 547 patients with intermittent allergic rhinitis, including seasonal and perennial forms. Both trials were randomized, double-blind, and placebo-controlled.

Is 5-mg Desloratadine the same as desloratadine?

5-mg Desloratadine is a specific dosage form of desloratadine, an antihistamine medication. The drug is being developed by Organon & Co. for the treatment of allergic rhinitis. It is currently in Phase 3 clinical trials and is not yet approved for use.