Last updated: 02/04/2020 18:40:05
Special Drug Use Investigation for XYZAL (Long-term)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Special Drug Use Investigation for XYZAL (Long-term)
Trial description: This post-marketing surveillance study (PMS) is conducted to collect safety and efficacy data for long-term use among patients with allergic rhinitis or skin disease who are treated with levocetirizine tablets for the first time.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Changes in clinical symptoms
Timeframe: 24 weeks
Occurrence of adverse drug reactions under clinical practice
Timeframe: 24 weeks
Changes in quality of life's scores
Timeframe: 24 weeks
Secondary outcomes:
Not applicable
Interventions:
Drug: Levocetirizine tablets
Enrollment:
511
Observational study model:
Cohort
Primary completion date:
2016-08-02
Time perspective:
Prospective
Clinical publications:
Kanami Sugimoto; Yukiko Ashihara; Kyoko Murakami; Terufumi Hara. Long-Term Safety and efficacy of levocetirizine hydrochloride (Xyzal? Tablets 5 mg) in patients with allergic rhinitis and skin diseases - Special Drug Use Investigation Final Report. J Clin Therapeut Med. 2016;32(11):905-922.
Medical condition
Rhinitis, Allergic, Perennial and Seasonal
Product
levocetirizine
Collaborators
Not applicable
Study date(s)
September 2012 to February 2016
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
none
- Adult patients with allergic rhinitis, urticaria, eczema/dermatitis,prurigo or pruritus cutaneous
- Pediatric patients with allergic rhinitis, urticaria or itching associated with skin diseases (eczema/dermatitis, pruritus cutaneous)
- None
Inclusion and exclusion criteria
Inclusion criteria:
- Adult patients with allergic rhinitis, urticaria, eczema/dermatitis,prurigo or pruritus cutaneous
- Pediatric patients with allergic rhinitis, urticaria or itching associated with skin diseases (eczema/dermatitis, pruritus cutaneous)
- Patients who are treated with levocetirizine for the first time
- Patients who are expected for long-term use (24 weeks)
Exclusion criteria:
- None
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
Protocol
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
2016-08-02
Actual study completion date
2016-08-02
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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