Clinical trial NCT02264535: A Pilot Study for Ginkgolides Meglumine Injection Skin Testing.
Official title: A Pilot Study for Ginkgolides Meglumine Injection Skin Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergy
Keywords: Allergy
Skin test
Ginkgolides Meglumine Injection
Lead sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Bionovo Medicine Development Co., Ltd.
First posted: 2014-10-15
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This pilot study is designed to explore the optimal concentration and method of Ginkgolides Meglumine Injection skin testing and to evaluate the value of skin test in predicting any possible allergic reactions to Ginkgolides Meglumine Injection.

Detailed description: Subjects will be enrolled in one of three groups with different doses to receive skin prick testing. Then they may be arranged to receive intradermal, subcutaneous injection or intravenous tests with different doses.

Eligibility criteria: Inclusion Criteria:

* Male and female between the ages of 18 and 70(inclusive)at the time of signing the Informed Consent Form （ICF）.
* Subjects meet any one of the following requirements

  * No history of using any dugs containing bilobalide, Ginkgolide A, Ginkgolide B, Ginkgolide K (including Ginkgolides Meglumine Injection).
  * History of using any dugs containing bilobalide, Ginkgolide A, Ginkgolide B, Ginkgolide K (including Ginkgolides Meglumine Injection), and no allergy.
  * History of allergy to any dugs contain bilobalide, Ginkgolide A, Ginkgolide B, Ginkgolide K (including Ginkgolides Meglumine Injection).
  * History of allergy to any other drugs.
* Willingness to participate in the study as evidenced by signing the informed consent form.

Exclusion Criteria:

* Women in breastfeeding,menstrual or pregnancy period.
* Subjects are in the infectious disease, eczema, dermatitis, trauma,etc.
* Subjects meet any one of the following conditions

  * Used β-blockers within 2 days prior to starting this study.
  * Used H1 anti-histamines, imipramine, phenothiazine, Beta adrenaline etc. within 1 week prior to starting this study.
  * Used short-acting glucocorticoids drugs within 1 week prior to starting this study.
  * Topical used glucocorticoids drugs within 2 weeks prior to starting this study.
  * Used long-acting glucocorticoids drugs within 4 weeks prior to starting this study
* Subjects are currently participating or have participated in any other clinical trials within the prior 1 month of signing the ICF.
* Subjects have a history of allergic shock.
* Subjects who are not suitable for this clinical trial at the discretion of the investigator.

Primary outcomes:
measure: The rate of allergic reaction and analyze all kinds of positive reactions after skin prick test with different doses of Ginkgolides Meglumine Injection.
timeFrame: 15-20 minutes after skin prick tests.
measure: The rate of allergic reaction and analyze all kinds of positive reactions after using intradermal tests of different doses of Ginkgolides Meglumine Injection.
timeFrame: 15-20 minutes after intradermal tests.
Secondary outcomes:
measure: The specificity and sensitivity with the different doses.
timeFrame: 15-20 minutes after prick-puncture and intradermal tests, 72 hours after subcutaneous test.
measure: Safety assessment will be based on adverse event reports, electrocardiogram, physical examinations and clinical laboratory tests.
timeFrame: within 7days before using Ginkgolides Meglumine Injectionand 3-10 days after using it.
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Second Affiliated Hospital of Tianjin University of TCM
Study officials:
affiliation: Second Affiliated Hospital of Tianjin University of TCM
name: Yuhong Huang
role: PRINCIPAL_INVESTIGATOR
References: