Rhinitis, Urticaria
Conditions
Brief summary
Eligible patients will be prescribed Desloratadine 1 tablet of 5 mg once daily. Patients will be asked to follow-up for a final visit after 14 days (Day 15) where the safety, tolerability and clinical efficacy will be measured.
Interventions
DRUGDesloratadine
Desloratadine 5 mg once daily
Sponsors
Organon and Co
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Outpatient men or women, age 12 years and above. * Diagnosis of Allergic Rhinitis or Chronic Idiopathic Urticaria
Exclusion criteria
* Known hypersensitivity to Desloratadine. * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Final Visit (Day 15) | Number of adverse events reported |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Desloratadine Desloratadine 5 mg daily | 3,011 |
| Total | 3,011 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 9 |
| Overall Study | Failure of Therapy | 4 |
| Overall Study | Lost to Follow-up | 36 |
| Overall Study | No Info | 25 |
| Overall Study | Poor Compliance | 16 |
Baseline characteristics
| Characteristic | Desloratadine |
|---|---|
| Age, Categorical <=18 years | 239 Participants |
| Age, Categorical >=65 years | 230 Participants |
| Age, Categorical Between 18 and 65 years | 2542 Participants |
| Sex: Female, Male Female | 1788 Participants |
| Sex: Female, Male Male | 1223 Participants |
Outcome results
Primary
Adverse Events
Number of adverse events reported
Time frame: Final Visit (Day 15)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Desloratadine | Adverse Events | Mild | 41 adverse events reported |
| Desloratadine | Adverse Events | Moderate | 15 adverse events reported |
| Desloratadine | Adverse Events | Severe | 1 adverse events reported |