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A Pilot Study for Ginkgolides Meglumine Injection Skin Testing.

Primary Purpose

Allergy

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
0.1mg/ml Ginkgolides Meglumine Injection
1mg/ml Ginkgolides Meglumine Injection
5mg/ml Ginkgolides Meglumine Injection
Sponsored by
Jiangsu Kanion Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Allergy focused on measuring Allergy, Skin test, Ginkgolides Meglumine Injection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Second Affiliated Hospital of Tianjin University of TCM

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

0.1mg/ml Ginkgolides Meglumine Injection

1mg/ml Ginkgolides Meglumine Injection

5mg/ml Ginkgolides Meglumine Injection

Arm Description

Injection, 0.1mg/ml.

Injection, 1mg/ml.

Injection, 5mg/ml.

Outcomes

Primary Outcome Measures

The rate of allergic reaction and analyze all kinds of positive reactions after skin prick test with different doses of Ginkgolides Meglumine Injection.
The rate of allergic reaction and analyze all kinds of positive reactions after using intradermal tests of different doses of Ginkgolides Meglumine Injection.

Secondary Outcome Measures

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).
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..

Full Information

First Posted
September 4, 2014
Last Updated
November 26, 2014
Sponsor
Jiangsu Kanion Pharmaceutical Co., Ltd
Collaborators
Beijing Bionovo Medicine Development Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02264535
Brief Title
A Pilot Study for Ginkgolides Meglumine Injection Skin Testing.
Official Title
A Pilot Study for Ginkgolides Meglumine Injection Skin Testing
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Kanion Pharmaceutical Co., Ltd
Collaborators
Beijing Bionovo Medicine Development Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy
Keywords
Allergy, Skin test, Ginkgolides Meglumine Injection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.1mg/ml Ginkgolides Meglumine Injection
Arm Type
Experimental
Arm Description
Injection, 0.1mg/ml.
Arm Title
1mg/ml Ginkgolides Meglumine Injection
Arm Type
Experimental
Arm Description
Injection, 1mg/ml.
Arm Title
5mg/ml Ginkgolides Meglumine Injection
Arm Type
Experimental
Arm Description
Injection, 5mg/ml.
Intervention Type
Drug
Intervention Name(s)
0.1mg/ml Ginkgolides Meglumine Injection
Intervention Type
Drug
Intervention Name(s)
1mg/ml Ginkgolides Meglumine Injection
Intervention Type
Drug
Intervention Name(s)
5mg/ml Ginkgolides Meglumine Injection
Primary Outcome Measure Information:
Title
The rate of allergic reaction and analyze all kinds of positive reactions after skin prick test with different doses of Ginkgolides Meglumine Injection.
Time Frame
15-20 minutes after skin prick tests.
Title
The rate of allergic reaction and analyze all kinds of positive reactions after using intradermal tests of different doses of Ginkgolides Meglumine Injection.
Time Frame
15-20 minutes after intradermal tests.
Secondary Outcome Measure Information:
Title
The specificity and sensitivity with the different doses.
Description
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).
Time Frame
15-20 minutes after prick-puncture and intradermal tests, 72 hours after subcutaneous test.
Title
Safety assessment will be based on adverse event reports, electrocardiogram, physical examinations and clinical laboratory tests.
Description
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..
Time Frame
within 7days before using Ginkgolides Meglumine Injectionand 3-10 days after using it.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuhong Huang
Organizational Affiliation
Second Affiliated Hospital of Tianjin University of TCM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital of Tianjin University of TCM
City
Tianjin
ZIP/Postal Code
300150
Country
China

12. IPD Sharing Statement

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A Pilot Study for Ginkgolides Meglumine Injection Skin Testing.

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