Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346606
Status:
UNKNOWN
Last Update Posted:
2006-06-30
First Post:
2006-06-29
Brief Title:
The Efficacy and Safety of Desloratadine With Levocetirizine in Treatment of Chronic Idiopathic Urticaria
Sponsor:
Lotus Pharmaceutical
Organization:
Lotus Pharmaceutical
Study Overview
Official Title:
A Randomized Double-Blind Active-Controlled Parallel-Group Study to Compare the Efficacy and Safety of Desloratadine 5mg Denosin With Levocetirizine 5mg Xyzal in the Treatment of Chronic Idiopathic Urticaria Patients
Status:
UNKNOWN
Status Verified Date:
2006-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective To compare the efficacy of desloratadine 5mg Denosin and levocetirizine 5mg Xyzal once daily in the treatment of patients with CIU over 6 weeks
Trial design Randomized Double-Blind Active-Controlled Parallel-Group Study
Primary end point To evaluate the change in average AMPM reflective pruritus score from baseline recorded in the subjects diaries during the first two weeks of the treatment
Secondary Objectives To assess the efficacy and safety of desloratadine 5mg Denosin and levocetirizine 5mg Xyzal once daily in the treatment of subjects with CIU over 6 weeks
Trial design Randomized Double-Blind Active-Controlled Parallel-Group Study
Primary end point To evaluate the change in average AMPM reflective pruritus score from baseline recorded in the subjects diaries during the first two weeks of the treatment
Secondary Objectives To assess the efficacy and safety of desloratadine 5mg Denosin and levocetirizine 5mg Xyzal once daily in the treatment of subjects with CIU over 6 weeks
Detailed Description:
Objective To compare the efficacy of desloratadine 5mg Denosin and levocetirizine 5mg Xyzal once daily in the treatment of patients with CIU over 6 weeks
Trial design Randomized Double-Blind Active-Controlled Parallel-Group Study
Primary endpoint To evaluate the change in average AMPM reflective pruritus score from baseline recorded in the subjects diaries during the first two weeks of the treatment
Secondary Objectives To assess the efficacy and safety of desloratadine 5mg Denosin and levocetirizine 5mg Xyzal once daily in the treatment of subjects with CIU over 6 weeks
Primary endpoint
To evaluate the change in average AMPM reflective pruritus score from baseline recorded in the patient diaries during the first two weeks of treatment
Secondary Endpoints- To evaluate the change in average AMPM reflective pruritus score from baseline recorded in the subjects diaries over the 6 weeks
To evaluate the reflective average AMPM scores for number of hives size of largest hive and total symptom score sum of pruritus number of hives and size of largest hive scores
Average individual AMPM instantaneous scores for pruritus number of hives and size of largest hive are also evaluated
AM instantaneous scores for pruritus number of hives and size of largest hive are also evaluated
PM instantaneous scores for pruritus number of hives and size of largest hive are also evaluated
PM reflective scores for pruritus number of hives and size of largest hive are also evaluated
The interference with sleep AM reflective and interference with daily activities PM reflective are other secondary efficacy outcomes
Therapeutic response will be evaluated at visit 35
Safety will be evaluated including vital signs are recorded at all visits whereas sleep latency using Epworth Sleepiness Scale ESS questionnaire and Visual analogue Scale VAS are scored at visit 25 Stanford Sleepiness Scale SSS are scored according to the instructions of diary cards at all visits All adverse events are recorded and graded for severity at visit 25
Trial design Randomized Double-Blind Active-Controlled Parallel-Group Study
Primary endpoint To evaluate the change in average AMPM reflective pruritus score from baseline recorded in the subjects diaries during the first two weeks of the treatment
Secondary Objectives To assess the efficacy and safety of desloratadine 5mg Denosin and levocetirizine 5mg Xyzal once daily in the treatment of subjects with CIU over 6 weeks
Primary endpoint
To evaluate the change in average AMPM reflective pruritus score from baseline recorded in the patient diaries during the first two weeks of treatment
Secondary Endpoints- To evaluate the change in average AMPM reflective pruritus score from baseline recorded in the subjects diaries over the 6 weeks
To evaluate the reflective average AMPM scores for number of hives size of largest hive and total symptom score sum of pruritus number of hives and size of largest hive scores
Average individual AMPM instantaneous scores for pruritus number of hives and size of largest hive are also evaluated
AM instantaneous scores for pruritus number of hives and size of largest hive are also evaluated
PM instantaneous scores for pruritus number of hives and size of largest hive are also evaluated
PM reflective scores for pruritus number of hives and size of largest hive are also evaluated
The interference with sleep AM reflective and interference with daily activities PM reflective are other secondary efficacy outcomes
Therapeutic response will be evaluated at visit 35
Safety will be evaluated including vital signs are recorded at all visits whereas sleep latency using Epworth Sleepiness Scale ESS questionnaire and Visual analogue Scale VAS are scored at visit 25 Stanford Sleepiness Scale SSS are scored according to the instructions of diary cards at all visits All adverse events are recorded and graded for severity at visit 25
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None