A comparative study on the efficacy and safety of Olopatadine Hydrochloride versus Cetirizine in the treatment of cutaneous pruritus

Recruitment status:
Not Recruiting
Primary Sponsor:
Peking Union Medical College Hospital
Recruitment countries:
Health condition studied:
Cutaneous pruritus
Link to the clinical trial website

About the trial

Group A:Olopatadine 5mg, oral taken twice daily for 2 week;Group B:Cetirizine 10mg, oral taken once daily for 2 weeks ;
Key inclusion and exclusion criteria:
  • Inclusion criteria: 1. 18-65 years old;
    2. All the participants were in agreement with the CP criteria and the severity of patient itching was evaluated by using a standardized scale (i.e., 0 = no itching; 6 = severe itching);
    3. The symptom score was greater than or equal to 3.
  • Exclusion criteria: 1. Gravid and or lactating female (women of child-bearing period also underwent a urinary pregnancy test when necessary);
    2. Workers under a high risk or drivers; subjects participating in another clinical trial or having participated in one in the last 3 months;
    3. Patients that had organic heart diseases, arrhythmia and electrocardiographic abnormality;
    4. Liver or renal function abnormality;
    5. Patients that had been allergic to the study medication or the control; or a clinically significant abnormality, i.e., patients with malignance or who had a myocardial infarction or used sedative and ataractic medication.
  • Age minimum: 
  • Age maximum: 
  • Gender:  Both
Primary outcomes:
symptom score reducing index (SSRI);
Secondary outcomes:
The global efficact;
Target sample size:
Group A:86;Group B:88;
Study type:
Interventional study
Study design:
Randomized parallel controlled trial
  • Name: Daojiang Shen 
  • Address:  970 Longdong Road, Pudong New Area, Shanghai, China
  • Phone:  +86 21 50800909
  • Email:  shendaojiang@kirinkunpeng.com.cn
  • Affiliation:  Kirin Kunpeng (China) Bio-Pharmaceutical Co.,Ltd.
  • Name: Jia Yin, Yuehua Liu 
  • Address:  1 Shuaifuyuan, Dongcheng District, Beijiang, China
  • Phone:  +86 10 65296349
  • Email:  yuehualiu63@gmail.com
  • Affiliation: 

Technical details

Scientific title:
A comparative study on the efficacy and safety of Olopatadine Hydrochloride versus Cetirizine in the treatment of cutaneous pruritus
Sources of monetary support:
Kyowa Hakko Kogyo Co., Ltd.(merged with Kirin Kunpeng (China) Bio-Pharmaceutical Co.,Ltd. in Jan. 2011.)
Secondary sponsors:
Main ID:
Secondary ID:
Date of registration:
Date of first enrollment:
Last refreshed:
18 April 2017


Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record

Back to clinical trials list