Adverse Reaction to DrugNCT05645302
Intensive Monitoring Scheme of Lidocaine Cataplasms
An observational study of Adverse Reaction to Drug, run by Qianfoshan Hospital at 1 site in China.
Trial summary
In this center, retrospective research methods are used to collect data. Patients who had used Lidocaine Cataplasms at least once were included consecutively. Taking the time when the patient first used Lidocaine Cataplasms as the starting time (the study baseline), collect the demographic characteristics of the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adverse Reaction to Drug
- What is being tested?
- Lidocaine Cataplasms
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2022to 31 Dec 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have used Lidocaine Cataplasms at least 1 consecutive time between January 1, 2021 and April 1, 2022.
Who may be able to join
- All patients receiving Lidocaine Cataplasms from January 1, 2021 to April 1, 2022.
Who cannot join
- Unable to obtain complete medication information.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, 250014
wei Xu, PHD, 86-17686791319, weixu@sdu.edu.cn
About this study
In this center, retrospective research methods are used to collect data. Patients who had used Lidocaine Cataplasms at least once were included consecutively. Taking the time when the patient first used Lidocaine Cataplasms as the starting time (the study baseline), collect the demographic characteristics of the patient, the medication scheme of Lidocaine Cataplasms and other information, as well as the medication safety and other information from the first medication to the end of medication or discharge (whichever occurs first).
- Conditions
- Adverse Reaction to Drug
- Being tested
- Lidocaine Cataplasms
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine CataplasmsDrug
The main ingredient of this product is lidocaine, the cream surface is white or almost white, the cream is evenly spread on the back, and the cream surface is covered with film.
| Study group | Role | What they receive |
|---|---|---|
| Patients using Lidocaine Cataplasms | Not described Receives: Drug: Lidocaine Cataplasms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Past medical history and other diseases that the researcher thinks have clinical significance. Collect the frequency, type, years, etc. of drinking and/or smoking, as well as the family history of diseases. Including white blood cell, red blood cell, hemoglobin, platelet count, etc. Including white blood cells, red blood cells, urine protein, urine sugar, etc. Including ALT, AST, ALP, TBil, GGT, BUN, Cr, etc. The researcher issued a prescription of lidocaine gel plaster according to the drug instructions, and recorded the indications, medication time, dose, frequency, drug batch number, etc. It includes all kinds of reactions unrelated to the treatment purpose during the study period, including symptoms, signs, laboratory abnormalities with clinical significance or special examinations.administration or discharge.
Measured: January 1, 2021 - April 1, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start6 Apr 2022
- Primary completion31 Oct 2022
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Reaction to DrugStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Xu, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645302
- Sponsor's protocol ID
- ZT-DBN-ZDJC-01
- Status last verified
- Nov 2022
- First submitted
- 22 Nov 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Monitoring Scheme of Lidocaine Cataplasms
- ClinicalTrials.gov ID
- NCT05645302
- Acronym / sponsor ID
- ZT-DBN-ZDJC-01
- Conditions
- Adverse Reaction to Drug
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this center, retrospective research methods are used to collect data. Patients who had used Lidocaine Cataplasms at least once were included consecutively. Taking the time when the patient first used Lidocaine Cataplasms as the starting time (the study baseline), collect the demographic characteristics of the patient, the medication scheme of Lidocaine Cataplasms and other information, as well as the medication safety and other information from the first medication to the end of medication or discharge (whichever occurs first).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients using Lidocaine Cataplasms | – | Drug: Lidocaine Cataplasms |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have used Lidocaine Cataplasms at least 1 consecutive time between January 1, 2021 and April 1, 2022.
Key inclusion criteria (1 listed)
- All patients receiving Lidocaine Cataplasms from January 1, 2021 to April 1, 2022.
Key exclusion criteria (1 listed)
- Unable to obtain complete medication information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine CataplasmsThe main ingredient of this product is lidocaine, the cream surface is white or almost white, the cream is evenly spread on the back, and the cream surface is covered with film. | Drug | Patients using Lidocaine Cataplasms |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: January 1, 2021 - April 1, 2022
Past medical history and other diseases that the researcher thinks have clinical significance. Collect the frequency, type, years, etc. of drinking and/or smoking, as well as the family history of diseases. Including white blood cell, red blood cell, hemoglobin, platelet count, etc. Including white blood cells, red blood cells, urine protein, urine sugar, etc. Including ALT, AST, ALP, TBil, GGT, BUN, Cr, etc. The researcher issued a prescription of lidocaine gel plaster according to the drug instructions, and recorded the indications, medication time, dose, frequency, drug batch number, etc. It includes all kinds of reactions unrelated to the treatment purpose during the study period, including symptoms, signs, laboratory abnormalities with clinical significance or special examinations.administration or discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Reaction to Drug, run by Qianfoshan Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Dec 2022. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Xu, MD (17686791319, weixu@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: January 1, 2021 - April 1, 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2022.