AzTrials
AzTrials

AllergyPhase 4NCT02264535

A Pilot Study for Ginkgolides Meglumine Injection Skin Testing.

A Phase 4 study testing 0.1mg/ml Ginkgolides Meglumine Injection, 1mg/ml Ginkgolides Meglumine Injection and 5mg/ml Ginkgolides Meglumine Injection in people with Allergy, run by Jiangsu Kanion Pharmaceutical Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Allergy
What is being tested?
0.1mg/ml Ginkgolides Meglumine Injection, 1mg/ml Ginkgolides Meglumine Injection and 5mg/ml Ginkgolides Meglumine Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
149 participants
Where
1 siteChina
Study dates
Jun 2014to Nov 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Second Affiliated Hospital of Tianjin University of TCM

    Tianjin, 300150

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Allergy
Being tested
0.1mg/ml Ginkgolides Meglumine Injection, 1mg/ml Ginkgolides Meglumine Injection, 5mg/ml Ginkgolides Meglumine Injection
Keywords
Allergy, Skin test, Ginkgolides Meglumine Injection
Medical subject headings
Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.1mg/ml Ginkgolides Meglumine InjectionDrug

  • 1mg/ml Ginkgolides Meglumine InjectionDrug

  • 5mg/ml Ginkgolides Meglumine InjectionDrug

Study groups in NCT02264535
Study groupRoleWhat they receive
0.1mg/ml Ginkgolides Meglumine InjectionExperimentalInjection, 0.1mg/ml.
Receives: Drug: 0.1mg/ml Ginkgolides Meglumine Injection
1mg/ml Ginkgolides Meglumine InjectionExperimentalInjection, 1mg/ml.
Receives: Drug: 1mg/ml Ginkgolides Meglumine Injection
5mg/ml Ginkgolides Meglumine InjectionExperimentalInjection, 5mg/ml.
Receives: Drug: 5mg/ml Ginkgolides Meglumine Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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.

    Measured: 15-20 minutes after intradermal tests.

Secondary outcomes (2)

  1. 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).

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

  2. 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..

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02264535
Sponsor's protocol ID
Z-YXPU-ZS-IV4
Status last verified
Apr 2014
First submitted
4 Sep 2014
Last updated
2 Dec 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 0.1mg/ml Ginkgolides Meglumine Injection, 1mg/ml Ginkgolides Meglumine Injection and 5mg/ml Ginkgolides Meglumine Injection in people with Allergy, run by Jiangsu Kanion Pharmaceutical Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02264535.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in