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:
China
Health condition studied:
Cutaneous pruritus
URL:
Link to the clinical trial website

About the trial

Interventions:
Group A:Olopatadine 5mg, oral taken twice daily for 2 weeks;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 efficacy;
Target sample size:
Group A:86;Group B:88;
Study type:
Interventional
Study design:
Randomized parallel control
Contacts:
  • Name: Daojiang Shen 
  • Address:  No.970, Longdong Road, Pudong New Area, Shanghai, China
  • Phone:  +86 21 50800909
  • Email:  shendaojiang@kirinkunpeng.com.cn
  • Affiliation: 
  • Name: Jia Yin, Yuehua Liu 
  • Address:  No.1, Shuaifuyuan, Dongcheng District Beijiang, 100730 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:
Kyowa Hakko Kogyo Co., Ltd.
Main ID:
ChiCTR-TRC-11001485
Secondary ID:
Register:
ChiCTR
Date of registration:
2011-08-25
Date of first enrollment:
2007-08-20
Last refreshed:
29 June 2014

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