Last updated: 11/07/2018 08:33:50
Drug Use Investigation for XYZAL®
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Drug Use Investigation for XYZAL
Trial description: This post-marketing surveillance study (PMS) is conducted to collect safety and efficacy data among subjects with allergic rhinitis, urticaria, eczema, dermatitis, skin irritation, prurigo or pruritus cutaneous who have never been treated with levocetirizine tablets before.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The number of adverse events in Japanese subjects treated with levocetirizine tablets
Timeframe: 4 weeks
Secondary outcomes:
Not applicable
Interventions:
Drug: Levocetirizine
Enrollment:
10728
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Tamami Kaneko, Ryoko Tanaka, Terufumi Hara, Pascal Yoshida.Safety and efficacy of levocetirizine hydrochloride (Xyzal® Tablets 5mg) in patients with allergic rhinitis and skin diseases - Drug Use Investigation Final Report (Study No : 115066) -.J Clin Therapeut Med.2014;30(10):885-903
Medical condition
Rhinitis, Allergic, Perennial and Seasonal
Product
levocetirizine
Collaborators
Not applicable
Study date(s)
February 2011 to December 2013
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- Must be the first time for taking levocetirizine tablet
- As this is PMS study, there are no exclusion criteria.
Inclusion and exclusion criteria
Inclusion criteria:
- Must be the first time for taking levocetirizine tablet
Exclusion criteria:
- As this is PMS study, there are no exclusion criteria.
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2013-27-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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