Post Marketing Surveillance for Contac… | Clinical Trial

Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Seasonal Allergic Rhinitis

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Drug Store Seki

Saitama, 340-0144, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male and female participants, between 15-65 years of age, who purchase the marketed cetrizine hydrochloride formulation

Exclusion criteria

Who have ever experienced allergic symptoms by taking this medication or any component of this medication, piperazine derivative (including levocetirizine, hydroxizine)
Those who have been under 15en diagnosed with kidney disease
Children under 15 years of age

Treatment and study plan

Cetrizine hydrochloride

Other

As provided on the patient information leaflet

Primary outcomes

Adverse events after having cetrizine hydrochloride

Time frame: At baseline

Participants will answer a questionnaire which consists of questions on safety of the marketed cetrizine hydrochloride formulation.

Secondary outcomes

Efficacy of the marketed cetrizine hydrochloride formulation

Time frame: At baseline

Participants will answer a questionnaire which consists of questions on their satisfaction after taking the marketed cetrizine hydrochloride formulation. The efficacy will be measured on a 4 point scale (1 Efficacious; 2 Somewhat efficacious; 3 Not efficacious; 4 Not known)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Contac Bien Z Adverse Effect Survey

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Dec 25, 2013
Registry last updated: May 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed