A Phase 3 interventional study of DEP114 and Desloratadine in Persistent Allergic Rhinitis, sponsored by EMS. Not yet recruiting. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by EMS · Phase 3, Interventional, and Treatment
The goal of this clinical trial is to learn whether DEP114 is effective in treating acute exacerbations of persistent allergic rhinitis in children aged 6 to less than 12 years. The study will also evaluate the safety of DEP114.
Participants will:
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
This study's planned enrollment of 316 is above the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.
Browse Rhinitis, Allergic studies →EMS is the lead sponsor of 84 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participants must take 5 mL per day
Drug: DEP114
The participants must take 5 mL per day
Drug: Desloratadine
The participants must take 5 mL per day
The participants must take 5 mL per day
Absolute change in the Total Nasal Symptom Score (TNSS) for nasal congestion, rhinorrhea, nasal itching, and sneezing, measured 5 days after treatment initiation (TNSS₀-₅).
The Total Nasal Symptom Score (TNSS) is the sum of the severity scores for each nasal symptom assessed (nasal congestion, rhinorrhea, nasal itching, and sneezing) over the previous 24 hours. The severity of each symptom is evaluated using a 4-point categorical scale (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The total score ranges from 0 to 12 points, with higher scores indicating more severe nasal symptoms and a worse clinical condition. Negative changes from baseline indicate improvement in symptoms.
Time frame: Day 5 after treatment initiation
Overall improvement of nasal symptoms throughout the treatment period.
Absolute change in the Total Nasal Symptom Score (TNSS) on treatment Days 1, 2, 3, 4, and 5 (TNSS₀-₁, TNSS₀-₂, ..., TNSS₀-₅).
Time frame: Day 5 after treatment initiation
Overall improvement of nasal symptoms 3 days after treatment initiation.
Proportion of participants with improvement in the Total Nasal Symptom Score (TNSS) at Day 3 after treatment initiation, where improvement is defined as a reduction of at least 4 points from baseline. TNSS ranges from 0 to 12 points, with higher scores indicating more severe nasal symptoms and a worse clinical condition; therefore, a decrease in TNSS represents clinical improvement.
Time frame: Day 3 after treatment initiation
Change From Baseline in Nasal Congestion Severity Assessed by the Nasal Congestion Severity Score (NCSS) Throughout the Treatment Period
Absolute change from baseline in the Nasal Congestion Severity Score (NCSS) on treatment Days 1, 2, 3, 4, and 5. NCSS ranges from 0 to 3 points, where higher scores indicate more severe nasal congestion and a worse clinical condition. Negative changes from baseline indicate improvement.
Time frame: From treatment initiation through Day 5 of treatment
Distribution of Participants by Rhinorrhea Severity Category Using the TNSS Rhinorrhea Item at Days 3 and 5
Distribution of participants according to rhinorrhea severity categories based on the rhinorrhea item of the Total Nasal Symptom Score (TNSS), assessed at Days 3 and 5 after treatment initiation.
Time frame: 3 and 5 days after treatment initiation
Improvement in Nasal Itching Severity Assessed by the Total Nasal Symptom Score (TNSS) at Days 3 and 5 After Treatment Initiation
Distribution of participants according to nasal itching severity assessed using the nasal itching item of the Total Nasal Symptom Score (TNSS) at Days 3 and 5 after treatment initiation.
Time frame: Day 3 and Day 5 after treatment initiation
Improvement in Sneezing Severity Assessed by the Total Nasal Symptom Score (TNSS) at Days 3 and 5 After Treatment Initiation
Distribution of participants according to sneezing severity assessed using the sneezing item of the Total Nasal Symptom Score (TNSS) at Days 3 and 5 after treatment initiation.
Time frame: Day 3 and Day 5 after treatment initiation
Global Assessment of Treatment by the Participant's Caregiver at Day 5 After Treatment Initiation
Distribution of participants according to the categories of the caregiver's global assessment of treatment scale: 0 = very poor, 1 = poor, 2 = neither good nor poor, 3 = good, and 4 = very good.
Time frame: Day 5 after treatment initiation
Investigator Global Assessment of Treatment at Day 5
Distribution of participants according to the investigator's global assessment of treatment score categories (0 = very poor, 1 = poor, 2 = neither good nor poor, 3 = good, and 4 = very good).
Time frame: Day 5 after treatment initiation
No study locations are listed for this record.
Start is estimated for Jun 2027; primary completion for Dec 2028, 18 months later.
Of 31 industry-sponsored phase 3 interventional studies under Rhinitis, Allergic, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 41. This study's planned 18 months is above that.
Counting every sponsor, half of 41 studies reached it within 13 months; a quarter within 6 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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