A Pilot Study for Ginkgolides Meglumine Injection Skin Testing.

A Pilot Study for Ginkgolides Meglumine Injection Skin Testing

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.

Study Overview

• Status: Completed
• Conditions: Allergy
• Intervention / Treatment: Drug: 0.1mg/ml Ginkgolides Meglumine Injection; Drug: 1mg/ml Ginkgolides Meglumine Injection; Drug: 5mg/ml 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.

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Tianjin, China, 300150
    • Second affiliated hospital of Tianjin university of tcm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 0.1mg/ml Ginkgolides Meglumine Injection; Injection, 0.1mg/ml.	Drug: 0.1mg/ml Ginkgolides Meglumine Injection
EXPERIMENTAL: 1mg/ml Ginkgolides Meglumine Injection; Injection, 1mg/ml.	Drug: 1mg/ml Ginkgolides Meglumine Injection
EXPERIMENTAL: 5mg/ml Ginkgolides Meglumine Injection; Injection, 5mg/ml.	Drug: 5mg/ml Ginkgolides Meglumine Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd
• Collaborators: Beijing Bionovo Medicine Development Co., Ltd.
• Investigators: Principal Investigator: Yuhong Huang, Second affiliated hospital of Tianjin university of tcm

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: September 4, 2014
• First Submitted That Met QC Criteria: October 9, 2014
• First Posted (ESTIMATE): October 15, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): December 2, 2014
• Last Update Submitted That Met QC Criteria: November 26, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Allergy; Skin test; Ginkgolides Meglumine Injection
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: Z-YXPU-ZS-IV4