Neuropathic PainPhase 2NCT02307305
Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?
A Phase 2 study testing Duloxetine and celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone in people with Neuropathic Pain, run by Hanyang University Seoul Hospital at 1 site in South Korea.
Trial summary
Range from 24% to 44%, with a prevalence of neuropathic-type pain from 6% to 20%-cause impairment in quality of life and functional capacity after total knee arthroplasty(TKA). Duloxetine (cymbalta) is a selective serotonin and nor-epinephrine reuptake inhibitor shown to be effective in treating chronic pain. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Duloxetine and celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2014to Dec 2016
- Phase
- Phase 2
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis of knee requiring TKA
Who cannot join
- Rheumatoid arthritis
- Other inflammatory arthritis
- Neuropsychiatric patients
- Hepatic insufficiency
- Renal insufficiency
- Patients older than 75
Show all 10Show fewer
- Allergy or intolerance to study medications
- Patients with an ASA of IV (angina, congestive heart failure, dementia, cerebrovascular accident)
- Chronic gabapentin or pregabalin use (regular use for longer than 3 months)
- Chronic opioid use (taking opioids for longer than 3 months)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Orthopaedic Surgery, Hanyang University, College of Medicine
Seoul, 133-792
Jinkyu Lee, +82-10-9582-7004, gaia-silver@hanmail.net
About this study
Range from 24% to 44%, with a prevalence of neuropathic-type pain from 6% to 20%-cause impairment in quality of life and functional capacity after total knee arthroplasty(TKA). Duloxetine (cymbalta) is a selective serotonin and nor-epinephrine reuptake inhibitor shown to be effective in treating chronic pain. Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and help regulate the perception of pain. Its effects on depression and anxiety symptoms, as well as its effect on pain perception, may be due to increasing the activity of serotonin and norepinephrine in the central nervous system. Approved for the acute and maintenance treatment of major depressive disorder, the acute treatment of generalized anxiety disorder, the management of diabetic peripheral neuropathic pain and the management of fibromyalgia, all in adults (18+).
Investigators will compare the neuropathic pain following TKA in duloxetine group (n=84) with those in non-duloxetine group (n=84). Investigators will classify the participants in to 2 groups (duloxetine and non-duloxetine group) randomly, and primarily evaluate the degree of neuropathic pain using the S-LANSS pain scale (preoperatively and postoperatively 3 and 6 months). All participants will receive postoperative pain control after TKA using the same pain control regimen except duloxetine.
Read the detailed description
Both groups of participants will receive pain control regimens as follows:
Preemptive analgesia : celebrex celecoxib, Patient controlled analgesia (postoperation 28 hours), During admission : celebrex BP or vimovo BP +ultracet ER BP, targin HS, Discharge medication: celebrex BP or vimovo BP, ultracet ER BP(PRN)
Drug generic names: celecoxib (celebrex), naproxen/esomeprazole (vimovo), acetaminophen/tramadol (ultracet ER), oxycodone/naloxone (targin)
- Conditions
- Neuropathic Pain
- Being tested
- Duloxetine, celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called cymbalta
- Phase I (preemptive): 2 hour before surgery (30mg for 1 day)
- Phase II (titration): POD#1~6 (30mg for another 6 days)
- Phase III (maintenance): POD#7~13(60mg for 7 days)
- Phase IV (tapering-1): POD#14~20 (30mg for 7 days)
- Phase V (tapering-2): POD#21~27 (30mg another every day for 7 days)
celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxoneDrug
Also called celebrex, vimovo, ultracet, targin
Preemptive analgesia : celebrex, Patient controlled analgesia (postop. 28 hours), During admission : celebrex BP or vimovo BP +ultracet ER BP, targin HS, Discharge medication: celebrex BP or vimovo BP, ultracet ER BP(PRN)
| Study group | Role | What they receive |
|---|---|---|
| Duloxetin group | Experimental | 1. Phase I (preemptive): 2 hour before surgery (30mg for 1 day)
2. Phase II (titration): POD#1~6 (30mg for another 6 days)
3. Phase III (maintenance): POD#7~13(60mg for 7 days)
4. Phase IV (tapering-1): POD#14~20 (30mg for 7 days)
5. Phase V (tapering-2): POD#21~27 (30mg another every day for 7 days)
plus routine pain control (celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone) Receives: Drug: Duloxetine; Drug: celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone |
| routine pain control group | Active comparator | Preemptive analgesia : celebrex, Patient controlled analgesia (postop. 28 hours), During admission : celebrex BP or vimovo BP +ultracet ER BP, targin HS, Discharge medication: celebrex BP or vimovo BP, ultracet ER BP(PRN)
Other name of drugs: celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone Receives: Drug: celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
neuropathic pain(the self assessed-Leeds Assessment of Neuropathic Symptoms and Signs pain scale, S-LANSS)
Measured: 6 months
Secondary outcomes (4)
Numeric rating scale for pain (NRS)
Measured: 6 months
American Knee Society knee and function score
Measured: 6 months
Western Ontario and McMaster University Arthritis Index (WOMAC)
Measured: 6 months
Geriatric depression scale-short form
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JIN KYU LEE, Hanyang University Seoul Hospital
- Investigators
- Choonghyeok Choi, Study chair, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307305
- Sponsor's protocol ID
- cymbaltaTKR
- Status last verified
- Feb 2016
- First submitted
- 27 Nov 2014
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?
- ClinicalTrials.gov ID
- NCT02307305
- Acronym / sponsor ID
- cymbaltaTKR
- Conditions
- Neuropathic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 4 Dec 2014 (estimated)
- 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.
Range from 24% to 44%, with a prevalence of neuropathic-type pain from 6% to 20%-cause impairment in quality of life and functional capacity after total knee arthroplasty(TKA). Duloxetine (cymbalta) is a selective serotonin and nor-epinephrine reuptake inhibitor shown to be effective in treating chronic pain. Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and help regulate the perception of pain. Its effects on depression and anxiety symptoms, as well as its effect on pain perception, may be due to increasing the activity of serotonin and norepinephrine in the central nervous system. Approved for the acute and maintenance treatment of major depressive disorder, the acute treatment of generalized anxiety disorder, the management of diabetic peripheral neuropathic pain and the management of fibromyalgia, all in adults (18+).
Investigators will compare the neuropathic pain following TKA in duloxetine group (n=84) with those in non-duloxetine group (n=84). Investigators will classify the participants in to 2 groups (duloxetine and non-duloxetine group) randomly, and primarily evaluate the degree of neuropathic pain using the S-LANSS pain scale (preoperatively and postoperatively 3 and 6 months). All participants will receive postoperative pain control after TKA using the same pain control regimen except duloxetine.
Detailed description
Both groups of participants will receive pain control regimens as follows:
Preemptive analgesia : celebrex celecoxib, Patient controlled analgesia (postoperation 28 hours), During admission : celebrex BP or vimovo BP +ultracet ER BP, targin HS, Discharge medication: celebrex BP or vimovo BP, ultracet ER BP(PRN)
Drug generic names: celecoxib (celebrex), naproxen/esomeprazole (vimovo), acetaminophen/tramadol (ultracet ER), oxycodone/naloxone (targin)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetin group | Experimental | Drug: Duloxetine, Drug: celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone1. Phase I (preemptive): 2 hour before surgery (30mg for 1 day) 2. Phase II (titration): POD#1~6 (30mg for another 6 days) 3. Phase III (maintenance): POD#7~13(60mg for 7 days) 4. Phase IV (tapering-1): POD#14~20 (30mg for 7 days) 5. Phase V (tapering-2): POD#21~27 (30mg another every day for 7 days) plus routine pain control (celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone) |
| routine pain control group | Active comparator | Drug: celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxonePreemptive analgesia : celebrex, Patient controlled analgesia (postop. 28 hours), During admission : celebrex BP or vimovo BP +ultracet ER BP, targin HS, Discharge medication: celebrex BP or vimovo BP, ultracet ER BP(PRN) Other name of drugs: celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Osteoarthritis of knee requiring TKA
Key exclusion criteria (10 listed)
- Rheumatoid arthritis
- Other inflammatory arthritis
- Neuropsychiatric patients
- Hepatic insufficiency
- Renal insufficiency
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 |
|---|---|---|
| DuloxetineAlso: cymbalta1. Phase I (preemptive): 2 hour before surgery (30mg for 1 day) 2. Phase II (titration): POD#1~6 (30mg for another 6 days) 3. Phase III (maintenance): POD#7~13(60mg for 7 days) 4. Phase IV (tapering-1): POD#14~20 (30mg for 7 days) 5. Phase V (tapering-2): POD#21~27 (30mg another every day for 7 days) | Drug | Duloxetin group |
| celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxoneAlso: celebrex, vimovo, ultracet, targinPreemptive analgesia : celebrex, Patient controlled analgesia (postop. 28 hours), During admission : celebrex BP or vimovo BP +ultracet ER BP, targin HS, Discharge medication: celebrex BP or vimovo BP, ultracet ER BP(PRN) | Drug | Duloxetin group, routine pain control group |
Primary outcome
neuropathic pain(the self assessed-Leeds Assessment of Neuropathic Symptoms and Signs pain scale, S-LANSS)
Time frame: 6 months
4 secondary outcomes
Numeric rating scale for pain (NRS)
Time frame: 6 months
American Knee Society knee and function score
Time frame: 6 months
Western Ontario and McMaster University Arthritis Index (WOMAC)
Time frame: 6 months
Geriatric depression scale-short form
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
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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.
Choonghyeok Choi study chair
Hanyang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Duloxetine and celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone in people with Neuropathic Pain, run by Hanyang University Seoul Hospital at 1 site in South Korea.
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 10 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 19 Feb 2016. 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 South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jinkyu Lee (+82-10-9582-7004, gaia-silver@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neuropathic pain(the self assessed-Leeds Assessment of Neuropathic Symptoms and Signs pain scale, S-LANSS) (time frame: 6 months). 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 19 Feb 2016.