Skip to main content
OpenTrials
Completed

NCT Number: NCT02264535

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Second Affiliated Hospital of Tianjin University of TCM

Tianjin, 300150, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.1mg/ml Ginkgolides Meglumine Injection

Drug

1mg/ml Ginkgolides Meglumine Injection

Drug

5mg/ml Ginkgolides Meglumine Injection

Drug

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. The specificity and sensitivity with the different doses.

    Time frame: 15-20 minutes after prick-puncture and intradermal tests, 72 hours after subcutaneous test.

    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).

  2. Safety assessment will be based on adverse event reports, electrocardiogram, physical examinations and clinical laboratory tests.

    Time frame: within 7days before using Ginkgolides Meglumine Injectionand 3-10 days after using it.

    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..

Sponsors and collaborators

Lead sponsor

Jiangsu Kanion Pharmaceutical Co., Ltd

Industry

Collaborators

  • Beijing Bionovo Medicine Development Co., Ltd.

Registry information

Official study title

A Pilot Study for Ginkgolides Meglumine Injection Skin Testing

Important dates

Study start
2014
Primary completion
2014
First posted
Oct 15, 2014
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.