A Pilot Study for Ginkgolides Meglumine Injection Skin Testing.

Allergy Clinical Trial

Official title:

A Pilot Study for Ginkgolides Meglumine Injection Skin Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02264535
• Other study ID #: Z-YXPU-ZS-IV4
• Status: Completed
• Phase: Phase 4
• First received: September 4, 2014
• Last updated: November 26, 2014
• Start date: June 2014

Study information

• Verified date: April 2014
• Source: Jiangsu Kanion Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 ß-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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Allergy

Intervention

Drug:
• 0.1mg/ml Ginkgolides Meglumine Injection

• 1mg/ml Ginkgolides Meglumine Injection

• 5mg/ml Ginkgolides Meglumine Injection

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Tianjin University of TCM	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Kanion Pharmaceutical Co., Ltd	Beijing Bionovo Medicine Development Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of allergic reaction and analyze all kinds of positive reactions after skin prick test with different doses of Ginkgolides Meglumine Injection.		15-20 minutes after skin prick tests.	No
Primary	The rate of allergic reaction and analyze all kinds of positive reactions after using intradermal tests of different doses of Ginkgolides Meglumine Injection.		15-20 minutes after intradermal tests.	No
Secondary	The specificity and sensitivity with the different doses.	Specificity (SPC) =TN/ (FP+TN); Sensitivity=TP/ (TP+FN). TP (true positive); TN (true negative); FP (false positive); FN (false negative). TP(true positive); TN(true negative); FP(false positive); FN(false negative).	15-20 minutes after prick-puncture and intradermal tests, 72 hours after subcutaneous test.	No
Secondary	Safety assessment will be based on adverse event reports, electrocardiogram, physical examinations and clinical laboratory tests.	Only the participants who are allergic to the main components of Ginkgolides Meglumine Injection will be assessed in 3-10 days after using it by the investigators..	within 7days before using Ginkgolides Meglumine Injectionand 3-10 days after using it.	Yes