Health Condition 1: L501- Idiopathic urticaria
Conditions
Interventions
Intervention1: Desloratadine 10 mg tablet: Dosage and administration: One tablet once a day with or without food.
Duration: 04 weeks
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Sun Pharma Laboratories Limited SPLL
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female patients aged between 18 and 65 years (both inclusive) 2.Patients with history of -Chronic Idiopathic Urticaria (CIU) more than or equal to 6 weeks prior to screening -An active CIU more than or equal to 3 weeks and with wheals present for more than or equal to 3 days/week prior to screening -Taking Desloratadine 5mg once daily since more than or equal to 2 weeks prior to screening and not responding to it 3.Moderate to severe CIU on the first day of screening 4.Moderate to severe CIU during 3 days prior to and on the day of enrolment 5.Patient willing to give informed consent and follow study protocol 6.Female patient of childbearing potential must be willing to use acceptable method of contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilized, or has not had a hysterectomy at least three months prior to the start of this study. Acceptable method of contraception includes (e.g., barrier method with spermicide). The "calendar method," withdrawal, or an IUD is NOT an acceptable method
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating woman 2.Surgical or medical condition that, in the judgment of the Investigator or Sponsor, could interfere with absorption, distribution, metabolism, or excretion of the drugs to be used 3.Have any of the following clinical conditions: -History of/or presence of clinically significant conditions including but not limited to: pulmonary, central nervous system, gastrointestinal, cardiovascular, thyroid, uncontrolled hypertension and diabetes, pancreatic, cancer, hepatic or renal disease -Symptomatic seasonal or perennial allergic rhinitis -Asthma not controlled by short acting beta2 agonists used as necessary -The presence of permanent severe diseases, especially those affecting the immune system, except urticarial -Presence of acute urticaria or any of the inducible urticaria -Had food or drug allergies manifested as skin reactions -Subjects who have been hospitalized because of worsening in their CU within 3 months prior to screening -Use of any antihistamines (except Desloratadine 5 mg once daily) within 2 weeks prior to screening 4.Subject who is hypersensitive to study medications or the components (e.g. Excipients) 5.Current or recent substance abuse, including alcohol 6.Participation in any experimental drug study within 60 days before screening 7.Subjects judged unfit for this study by investigator 8.Investigator, study personnel, sponsor representatives and their first degree relatives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Outcome: -Change in the weekly Urticaria Activity Score (UAS7) from baselineTimepoint: Time Frame: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Outcome: 1.Change in the weekly Urticaria Activity Score (UAS7) from baseline 2.Change in Chronic Urticaria Quality of Life (CU-Q2oL)scores from baseline Safety: Proportion of participants with adverse events and serious adverse events throughout studyTimepoint: 1.Time Frame: 2 weeks 2.Time Frame: 2, 4 weeks Safety: Time Frame: 4 weeks | — |
Countries
India
Contacts
Public ContactGuruprasad Palekar
Sun Pharma Laboratories Limited (SPLL)
Outcome results
None listed