Arthropathy of Knee JointPhase 4NCT05266027
Naldebain for Pain Management After Knee Arthroplasty
A Phase 4 study testing Nalbuphine Sebacate (Naldebain) in people with Arthropathy of Knee Joint, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Naldebain, a long-acting analgesic injection, obtained a license from the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare on March 6, 2017 to approve a sustained-release long-acting analgesic on the market in Taiwan. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Arthropathy of Knee Joint
- What is being tested?
- Nalbuphine Sebacate (Naldebain)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Apr 2022to 28 Nov 2022
- 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 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at least 50 years old, not exceed 100 years old
- Diagnosed Primary Knee Osteoarthritis accepted Knee Arthroplasty
Who cannot join
- Diagnosed inflammatory Arthritis、Rheumatoid Arthritis
- Accepted Revision Knee Arthroplasty
- Patients with head injury, intracranial injury, increased intracerebral pressure and liver insufficiency
- Patients who are allergic to nalbuphine sebacate, nalbuphine, sesame oil or benzyl benzoate drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Long-Acting Nalbuphine Sebacate (Naldebain) for Pain Management After Knee Arthroplasty
Naldebain, a long-acting analgesic injection, obtained a license from the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare on March 6, 2017 to approve a sustained-release long-acting analgesic on the market in Taiwan. This study hopes to use a rigorous double-blind randomized controlled experiment to understand whether the new sustained-release analgesic Naldebain can achieve effective pain relief for patients undergoing knee replacement surgery, and to evaluate the patient's functional recovery status .
Read the detailed description
Naldebain, a long-acting analgesic injection, obtained a license from the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare on March 6, 2017 to approve a sustained-release long-acting analgesic on the market in Taiwan. At present, it is the only analgesic injection that has an efficacy of up to seven days. The currently approved drug indication is to relieve moderate and severe acute pain after surgery. Pharmacological mechanisms and experiments show that its analgesic effect is equivalent to morphine, but its side effects are much lower than morphine. Because of its special pharmacological mechanism, it has extremely high potential to improve patients undergoing knee replacement surgery. Therefore, this study hopes to use a rigorous double-blind randomized controlled experiment to understand whether the new sustained-release analgesic Naldebain can achieve effective pain relief for patients undergoing knee replacement surgery, and to evaluate the patient's functional recovery status .
- Conditions
- Arthropathy of Knee Joint
- Being tested
- Nalbuphine Sebacate (Naldebain), Placebo medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalbuphine Sebacate (Naldebain)Drug
Nalbuphine Sebacate (Naldebain) 2mL/150mg would be intramuscularly injected during knee arthroplasty surgery.
Placebo medicationDrug
Placebo medication, Nalbuphine Sebacate not contained
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Nalbuphine Sebacate (Naldebain) intramuscular injection Receives: Drug: Nalbuphine Sebacate (Naldebain) |
| Placebo Group | Placebo comparator | Placebo medication intramuscular injection Receives: Drug: Placebo medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)
morphine consumption amount
Measured: Post operation Day1
The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)
morphine consumption amount
Measured: Post operation Day2
The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)
morphine consumption amount
Measured: Post operation Day3
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
Measured: Baseline
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
Measured: Post operation Day1
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
Measured: Post operation Day2
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
Measured: Post operation Day3
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
Measured: Post operation Day4
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
Measured: Post operation Day5
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
Measured: Post operation 2 weeks
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
Measured: Post operation 6 weeks
Secondary outcomes (3)
knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)
knee joint functional data questionnaire
Measured: Baseline
knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)
knee joint functional data questionnaire
Measured: Post operation 2 weeks
knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)
knee joint functional data questionnaire
Measured: Post operation 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start6 Apr 2022
- Primary completion28 Nov 2022
- Study completion28 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of Knee JointStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsuan-Ti Huang, M.D., Study director, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266027
- Sponsor's protocol ID
- KMUHIRB-F(I)-20210150
- Status last verified
- Nov 2022
- First submitted
- 20 Feb 2022
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Long-Acting Nalbuphine Sebacate (Naldebain) for Pain Management After Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05266027
- Acronym / sponsor ID
- KMUHIRB-F(I)-20210150
- Conditions
- Arthropathy of Knee Joint
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 28 Nov 2022 (actual)
- First posted
- 4 Mar 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.
Naldebain, a long-acting analgesic injection, obtained a license from the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare on March 6, 2017 to approve a sustained-release long-acting analgesic on the market in Taiwan. This study hopes to use a rigorous double-blind randomized controlled experiment to understand whether the new sustained-release analgesic Naldebain can achieve effective pain relief for patients undergoing knee replacement surgery, and to evaluate the patient's functional recovery status .
Detailed description
Naldebain, a long-acting analgesic injection, obtained a license from the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare on March 6, 2017 to approve a sustained-release long-acting analgesic on the market in Taiwan. At present, it is the only analgesic injection that has an efficacy of up to seven days. The currently approved drug indication is to relieve moderate and severe acute pain after surgery. Pharmacological mechanisms and experiments show that its analgesic effect is equivalent to morphine, but its side effects are much lower than morphine. Because of its special pharmacological mechanism, it has extremely high potential to improve patients undergoing knee replacement surgery. Therefore, this study hopes to use a rigorous double-blind randomized controlled experiment to understand whether the new sustained-release analgesic Naldebain can achieve effective pain relief for patients undergoing knee replacement surgery, and to evaluate the patient's functional recovery status .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Nalbuphine Sebacate (Naldebain)Nalbuphine Sebacate (Naldebain) intramuscular injection |
| Placebo Group | Placebo comparator | Drug: Placebo medicationPlacebo medication intramuscular injection |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age at least 50 years old, not exceed 100 years old
- Diagnosed Primary Knee Osteoarthritis accepted Knee Arthroplasty
Key exclusion criteria (4 listed)
- Diagnosed inflammatory Arthritis、Rheumatoid Arthritis
- Accepted Revision Knee Arthroplasty
- Patients with head injury, intracranial injury, increased intracerebral pressure and liver insufficiency
- Patients who are allergic to nalbuphine sebacate, nalbuphine, sesame oil or benzyl benzoate drugs
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 |
|---|---|---|
| Nalbuphine Sebacate (Naldebain)Nalbuphine Sebacate (Naldebain) 2mL/150mg would be intramuscularly injected during knee arthroplasty surgery. | Drug | Experimental Group |
| Placebo medicationPlacebo medication, Nalbuphine Sebacate not contained | Drug | Placebo Group |
Primary outcome
The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)
Time frame: Post operation Day1
morphine consumption amount
The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)
Time frame: Post operation Day2
morphine consumption amount
The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)
Time frame: Post operation Day3
morphine consumption amount
The level of pain index (Visual Analog Scale)
Time frame: Baseline
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
The level of pain index (Visual Analog Scale)
Time frame: Post operation Day1
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
The level of pain index (Visual Analog Scale)
Time frame: Post operation Day2
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
The level of pain index (Visual Analog Scale)
Time frame: Post operation Day3
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
The level of pain index (Visual Analog Scale)
Time frame: Post operation Day4
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
The level of pain index (Visual Analog Scale)
Time frame: Post operation Day5
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
The level of pain index (Visual Analog Scale)
Time frame: Post operation 2 weeks
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
The level of pain index (Visual Analog Scale)
Time frame: Post operation 6 weeks
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
3 secondary outcomes
knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)
Time frame: Baseline
knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)
Time frame: Post operation 2 weeks
knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)
Time frame: Post operation 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Hsuan-Ti Huang, M.D. study director
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nalbuphine Sebacate (Naldebain) in people with Arthropathy of Knee Joint, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 4 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 27 Mar 2023. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine) (time frame: Post operation Day1). The study lists 11 primary outcomes in all. 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 27 Mar 2023.