How Desloratadine (Clarinex, Aerius) Affects Quality of Life in Patients With Chronic Idiopathic Urticaria (Have Had Hives for 6 Weeks or Longer)(Study P02988)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: November 21, 2008
Last Update Posted: May 5, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
The purpose of this study was to determine the effect of desloratadine treatment on quality of life, daytime functioning, quality of sleep, symptoms, and disease severity in patients who had hives for 6 weeks or longer. Patients took desloratadine for 1 month. Once a week, patients filled out a questionnaire to tell how their hives affected their lives. This questionnaire is called the Dermatology Life Quality Index or DLQI. They also filled out a diary every day to tell how much itching they had, how many hives they had, and how their hives had affected their sleep or daily activities. The patients and doctors rated the patients' overall condition and how much relief patients got from treatment.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Open-Label Study of the Effects of Desloratadine Treatment on the Quality of Life of Patients With Chronic Urticaria|
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Change from baseline to day 28 in Dermatology Life Quality Index (DLQI) score [ Time Frame: Baseline and treatment day 28 ]
Secondary Outcome Measures:
- Change from Baseline in the DLQI score on treatment days 7, 14, 21 [ Time Frame: Baseline and treatment days 7, 14, 21 ]
- Change from Baseline in pruritus, the number of hives, sleep quality, and daily activity impairment on treatment days 7, 14, 21, and 28 [ Time Frame: Baseline and treatment days 7, 14, 21, and 28 ]
- Change from Baseline in the Overall Condition of chronic urticaria on treatment days 14 and 28 [ Time Frame: Baseline and treatment days 14 and 28 ]
- Percent of subjects who rate their response to therapy as either Complete, Marked, or Moderate Relief on treatment days 14 and 28 [ Time Frame: Treatment days 14 and 28 ]
- Evaluation of tolerability and safety by clinical laboratory tests [ Time Frame: Baseline and treatment day 28 ]
- Evaluation of tolerability and safety by adverse events [ Time Frame: Screening, Baseline, and treatment days 14 and 28 ]
|Study Start Date:||November 2002|
|Study Completion Date:||January 2004|
|Primary Completion Date:||January 2004 (Final data collection date for primary outcome measure)|
|Experimental: Arm 1||
desloratadine 5 mg tablets; one tablet orally once a day for 28 days
Other Name: Clarinex; Aerius; SCH 34117; descarboethoxyloratadine
Contacts and Locations
No Contacts or Locations Provided