Chronic PainNCT04559048
Investigation of Pain Incidence After FK506 Immunosuppressive Therapy in Liver Transplantation Patients
An observational study of Chronic Pain and Liver Transplantation, run by The Second Hospital of Tangshan at 1 site in China.
Trial summary
FK506 (tacrolimus), a calcineurin inhibitor, is widely used as an immunosuppressant to lower the risk of organ rejection after organ transplantation, and to treat T cell-mediated diseases such as eczema and atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Liver Transplantation
- What is being tested?
- FK506
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2019to 30 Jun 2024
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: A retrospective study was conducted in patients who underwent liver transplant from September of 2011 to May of 2018 in the Liver Health Rehabilitation Association(China)
Who may be able to join
- had liver transplantation for end-stage liver disease
- was ≥18 years of age at the time of liver transplantation -
Who cannot join
- liver cancer
- acute (fulminant) liver failure
- multiorgan transplant
- chronic postsurgical pain
- fibromyalgia, osteoarthritis, low back pain and inflammatory pain of any origin
- peripheral and central neuropathic pain of any origin
- chronic secondary visceral pain
- chronic cancer-related pain that is due to cancer or its treatment -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Tangshan
Tangshan, Hebei, 063000
Gang Zhao, M.D., +8603152058037, tseyyjk@163.com
About this study
FK506 (tacrolimus), a calcineurin inhibitor, is widely used as an immunosuppressant to lower the risk of organ rejection after organ transplantation, and to treat T cell-mediated diseases such as eczema and atopic dermatitis. FK506 treatment often accompanies pain sensation in patients with atopic dermatitis or after organ transplantation. In previous studies, the investigators confirmed that FK506 treatment increased neuronal activity of primary afferent neurons and causes pain behavior in naïve mice. In order to further search for objective clinical evidence, the investigators proposed to investigate pain incidence after FK506 immunosuppressive therapy in liver transplantation patients. The investigators will investigate pain incidence and pain intensity in patients who underwent liver transplant from September of 2011 to May of 2018 in the Liver Health Rehabilitation Association. The patients who were divided into two groups based on whether or not FK506 was used in the immunosuppressive therapy. The patients in control group (without FK506 treatment) and FK506-treated group report pain sensation 3 months and 12 months after liver transplant. The investigators will compare the pain incidence between the two groups at both time points. On the other hand, the investigators will further investigate changes in pain sensation after 1st and 2nd reductions of FK506 dose. Pain is reported subjectively by the patient using the visual analogue scale (VAS) 1 month after dose reduction. In our study, 1st and 2nd reductions of FK506 dose refers to the first two dose-adjustments (approximately 6 months apart) that occurred 3-6 months after the liver transplantation.
- Conditions
- Chronic Pain, Liver Transplantation
- Being tested
- FK506
- Keywords
- Chronic Pain, Liver Transplantation, FK506
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FK506Drug
FK506 (tacrolimus), a calcineurin inhibitor, is widely used as an immunosuppressant to lower the risk of organ rejection after organ transplantation
| Study group | Role | What they receive |
|---|---|---|
| FK506-treated group | In FK506-treated group, the patients who underwent liver transplant are treated with FK506 immunosuppressive therapy. Receives: Drug: FK506 | |
| control group without FK506 treatment | In control group, the patients who underwent liver transplant are treated without FK506. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain incidence
Pain is defined as painful sensation that lasts or recurs for 1-3 months within 3 months after liver transplantation, or for longer than 3 months within 12 months after liver transplantation.
Measured: within 2 years after liver transplantation
pain intensity
Pain is reported subjectively by the patient using the visual analogue scale (VAS)
Measured: within 2 years after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start15 Sep 2019
- Primary completion15 Mar 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Tangshan
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Responsible party
- Sponsor
- Investigators
- Dequn Liu, M.D., Study chair, The Second Hospital of Tangshan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559048
- Sponsor's protocol ID
- HBTS1411206
- Status last verified
- Jan 2024
- First submitted
- 16 Sep 2020
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reitamo S, Rustin M, Ruzicka T, Cambazard F, Kalimo K, Friedmann PS, Schoepf E, Lahfa M, Diepgen TL, Judodihardjo H, Wollenberg A, Berth-Jones J, Bieber T; European Tacrolimus Ointment Study Group. Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone butyrate ointment in adult patients with atopic dermatitis. J Allergy Clin Immunol. 2002 Mar;109(3):547-55. doi: 10.1067/mai.2002.121832.
PubMed 11898005Malat GE, Dupuis RE, Kassman B, Rhoads JM, Freeman K, Lichtman S, Johnson MW, Gerber D, Andreoni K, Fair J. Tacrolimus-induced pain syndrome in a pediatric orthotopic liver transplant patient. Pediatr Transplant. 2002 Oct;6(5):435-8. doi: 10.1034/j.1399-3046.2002.02030.x.
PubMed 12390434
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pain Incidence After FK506 Immunosuppressive Therapy in Liver Transplantation Patients
- ClinicalTrials.gov ID
- NCT04559048
- Acronym / sponsor ID
- HBTS1411206
- Conditions
- Chronic Pain, Liver Transplantation
- Keywords
- Chronic Pain, Liver Transplantation, FK506
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Second Hospital of TangshanUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 22 Sep 2020 (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.
FK506 (tacrolimus), a calcineurin inhibitor, is widely used as an immunosuppressant to lower the risk of organ rejection after organ transplantation, and to treat T cell-mediated diseases such as eczema and atopic dermatitis. FK506 treatment often accompanies pain sensation in patients with atopic dermatitis or after organ transplantation. In previous studies, the investigators confirmed that FK506 treatment increased neuronal activity of primary afferent neurons and causes pain behavior in naïve mice. In order to further search for objective clinical evidence, the investigators proposed to investigate pain incidence after FK506 immunosuppressive therapy in liver transplantation patients. The investigators will investigate pain incidence and pain intensity in patients who underwent liver transplant from September of 2011 to May of 2018 in the Liver Health Rehabilitation Association. The patients who were divided into two groups based on whether or not FK506 was used in the immunosuppressive therapy. The patients in control group (without FK506 treatment) and FK506-treated group report pain sensation 3 months and 12 months after liver transplant. The investigators will compare the pain incidence between the two groups at both time points. On the other hand, the investigators will further investigate changes in pain sensation after 1st and 2nd reductions of FK506 dose. Pain is reported subjectively by the patient using the visual analogue scale (VAS) 1 month after dose reduction. In our study, 1st and 2nd reductions of FK506 dose refers to the first two dose-adjustments (approximately 6 months apart) that occurred 3-6 months after the liver transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FK506-treated group | – | Drug: FK506In FK506-treated group, the patients who underwent liver transplant are treated with FK506 immunosuppressive therapy. |
| control group without FK506 treatment | – | –In control group, the patients who underwent liver transplant are treated without FK506. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A retrospective study was conducted in patients who underwent liver transplant from September of 2011 to May of 2018 in the Liver Health Rehabilitation Association(China)
Key inclusion criteria (2 listed)
- had liver transplantation for end-stage liver disease
- was ≥18 years of age at the time of liver transplantation -
Key exclusion criteria (8 listed)
- liver cancer
- acute (fulminant) liver failure
- multiorgan transplant
- chronic postsurgical pain
- fibromyalgia, osteoarthritis, low back pain and inflammatory pain of any origin
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 |
|---|---|---|
| FK506FK506 (tacrolimus), a calcineurin inhibitor, is widely used as an immunosuppressant to lower the risk of organ rejection after organ transplantation | Drug | FK506-treated group |
Primary outcome
pain incidence
Time frame: within 2 years after liver transplantation
Pain is defined as painful sensation that lasts or recurs for 1-3 months within 3 months after liver transplantation, or for longer than 3 months within 12 months after liver transplantation.
pain intensity
Time frame: within 2 years after liver transplantation
Pain is reported subjectively by the patient using the visual analogue scale (VAS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Background: PubMed 11898005Reitamo S, Rustin M, Ruzicka T, Cambazard F, Kalimo K, Friedmann PS, Schoepf E, Lahfa M, Diepgen TL, Judodihardjo H, Wollenberg A, Berth-Jones J, Bieber T; European Tacrolimus Ointment Study Group. Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone butyrate ointment in adult patients with atopic dermatitis. J Allergy Clin Immunol. 2002 Mar;109(3):547-55. doi: 10.1067/mai.2002.121832.
- Background: PubMed 12390434Malat GE, Dupuis RE, Kassman B, Rhoads JM, Freeman K, Lichtman S, Johnson MW, Gerber D, Andreoni K, Fair J. Tacrolimus-induced pain syndrome in a pediatric orthotopic liver transplant patient. Pediatr Transplant. 2002 Oct;6(5):435-8. doi: 10.1034/j.1399-3046.2002.02030.x.
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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.
Dequn Liu, M.D. study chair
The Second Hospital of Tangshan
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 Chronic Pain and Liver Transplantation, run by The Second Hospital of Tangshan 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 2 inclusion and 8 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 22 Jan 2024. 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 Gang Zhao, M.D. (+8603152058037, tseyyjk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain incidence (time frame: within 2 years after liver transplantation). 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 NCT04559048, which also lists 2 linked publications.
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 22 Jan 2024.