Osteoarthritis Of KneePhase 1/2NCT03110172
Short-term Efficacy of Antidepressant in Patients Underwent TKA
A Phase 1/2 study testing Duloxetine Hydrochloride in people with Osteoarthritis Of Knee, run by Dalian Municipal Central Hospital at 1 site in China.
Trial summary
By taking certain antidepressant in early postoperative period，which is supposed to improve the psychological status of patients with osteoarthritis, explore the effect of certain antidepressant on the recovery of the early stage after the operation of knee joint replacement. Read more about this study
- Who is it for?
- Ages 51 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis Of Knee
- What is being tested?
- Duloxetine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Jul 2017
- Phase
- Phase 1/2
- 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 51 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No extra articular malformations are diagnosed and accord with Kellgren-Lawrence criteria
- Primary TKA surgery,Varus is smaller than 20°
- Always there is no history of mental illness, no history of relevant medicine
- Be able to read and understand Chinese, with good communication skills
- Voluntary participation in this clinical study
Who cannot join
- Previous history of mental and psychological illness
- With severe diseases in respiratory system, circulatory system or digestive system
- Allergic to duloxetine and celecoxib
Trial locations and contacts
1 site in 1 country.
About this study
By taking certain antidepressant in early postoperative period，which is supposed to improve the psychological status of patients with osteoarthritis, explore the effect of certain antidepressant on the recovery of the early stage after the operation of knee joint replacement.
Read the detailed description
In this study, the investigators are going to investigate the efficacy of Duloxetine on pain, physical function, mental health and quality of life in patients underwent TKAs.
The control group is going to be given celecoxib 200mg/24h to 2 weeks after operation.On the basis of the above scheme, the treatment group is going to receiving duloxetine 60mg/24h to 8 weeks after operation.HAMD-17 scale, KSS scale, SF-36 scale and WOMAC scale will be used to evaluate the two groups before and after operation for 4 and 8 weeks.
- Conditions
- Osteoarthritis Of Knee
- Being tested
- Duloxetine Hydrochloride
- Keywords
- Osteoarthritis, Depression, Pain
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Depression, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duloxetine HydrochlorideDrug
Also called Cymbalta
The treatment group will receive duloxetine 60mg/24h to 8 weeks after operation
| Study group | Role | What they receive |
|---|---|---|
| KSS scale | Active comparator | Knee Society Score with Duloxetine Hydrochloride Receives: Drug: Duloxetine Hydrochloride |
| HAMD-17 scale | Active comparator | Hamilton Depression Score with Duloxetine Hydrochloride Receives: Drug: Duloxetine Hydrochloride |
| SF-36 scale | Active comparator | Medical Outcomes Study Short Form-36 score with Duloxetine Hydrochloride Receives: Drug: Duloxetine Hydrochloride |
| WOMAC scale | Active comparator | Western Ontario and McMaster Universities Index with Duloxetine Hydrochloride Receives: Drug: Duloxetine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 4 weeks of treatment.
A face-to-face questionnaire will be conducted by two trained interviewers
Measured: up to 6 months
Function score of participants with Duloxetine as assessed by Knee Society Score after 4 weeks of treatment.
A face-to-face questionnaire will be conducted by two trained interviewers
Measured: up to 6 months
Secondary outcomes (2)
Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 8 weeks of treatment.
A face-to-face questionnaire will be conducted by two trained interviewers
Measured: up to 6 months
Function score of participants with Duloxetine as assessed by Knee Society Score after 8 weeks of treatment.
A face-to-face questionnaire will be conducted by two trained interviewers
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study startJan 2017
- Primary completionJun 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis Of KneeStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients will be randomly divided into two groups. The control group is going to be given celecoxib 200mg/24h to 2 weeks after operation. On the basis of the above scheme, the The treatment group will receive duloxetine 60mg/24h to 8 weeks after operation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalian Municipal Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Bin, Dalian Municipal Central Hospital
- Investigators
- QI Zhiming, MD, Study director, Dalian Municipal Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110172
- Sponsor's protocol ID
- I84412001
- Status last verified
- Apr 2017
- First submitted
- 3 Apr 2017
- Last updated
- 14 Apr 2017
- Results posted
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Efficacy of Antidepressant in Patients Underwent TKA
- ClinicalTrials.gov ID
- NCT03110172
- Acronym / sponsor ID
- I84412001
- Conditions
- Osteoarthritis Of Knee
- Keywords
- Osteoarthritis, Depression, Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Dalian Municipal Central HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 12 Apr 2017 (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.
By taking certain antidepressant in early postoperative period，which is supposed to improve the psychological status of patients with osteoarthritis, explore the effect of certain antidepressant on the recovery of the early stage after the operation of knee joint replacement.
Detailed description
In this study, the investigators are going to investigate the efficacy of Duloxetine on pain, physical function, mental health and quality of life in patients underwent TKAs.
The control group is going to be given celecoxib 200mg/24h to 2 weeks after operation.On the basis of the above scheme, the treatment group is going to receiving duloxetine 60mg/24h to 8 weeks after operation.HAMD-17 scale, KSS scale, SF-36 scale and WOMAC scale will be used to evaluate the two groups before and after operation for 4 and 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- All patients will be randomly divided into two groups. The control group is going to be given celecoxib 200mg/24h to 2 weeks after operation. On the basis of the above scheme, the The treatment group will receive duloxetine 60mg/24h to 8 weeks after operation.
| Arm | Type | Receives |
|---|---|---|
| KSS scale | Active comparator | Drug: Duloxetine HydrochlorideKnee Society Score with Duloxetine Hydrochloride |
| HAMD-17 scale | Active comparator | Drug: Duloxetine HydrochlorideHamilton Depression Score with Duloxetine Hydrochloride |
| SF-36 scale | Active comparator | Drug: Duloxetine HydrochlorideMedical Outcomes Study Short Form-36 score with Duloxetine Hydrochloride |
| WOMAC scale | Active comparator | Drug: Duloxetine HydrochlorideWestern Ontario and McMaster Universities Index with Duloxetine Hydrochloride |
Who may qualify
- Ages
- 51 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- No extra articular malformations are diagnosed and accord with Kellgren-Lawrence criteria
- Primary TKA surgery,Varus is smaller than 20°
- Always there is no history of mental illness, no history of relevant medicine
- Be able to read and understand Chinese, with good communication skills
- Voluntary participation in this clinical study
Key exclusion criteria (3 listed)
- Previous history of mental and psychological illness
- With severe diseases in respiratory system, circulatory system or digestive system
- Allergic to duloxetine and celecoxib
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 |
|---|---|---|
| Duloxetine HydrochlorideAlso: CymbaltaThe treatment group will receive duloxetine 60mg/24h to 8 weeks after operation | Drug | HAMD-17 scale, KSS scale, SF-36 scale, WOMAC scale |
Primary outcome
Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 4 weeks of treatment.
Time frame: up to 6 months
A face-to-face questionnaire will be conducted by two trained interviewers
Function score of participants with Duloxetine as assessed by Knee Society Score after 4 weeks of treatment.
Time frame: up to 6 months
A face-to-face questionnaire will be conducted by two trained interviewers
2 secondary outcomes
Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 8 weeks of treatment.
Time frame: up to 6 months
Function score of participants with Duloxetine as assessed by Knee Society Score after 8 weeks of treatment.
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Individual participant dataSharing planned: Yes
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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.
QI Zhiming, MD study director
Dalian Municipal Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Duloxetine Hydrochloride in people with Osteoarthritis Of Knee, run by Dalian Municipal Central 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 5 inclusion and 3 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 14 Apr 2017. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 4 weeks of treatment. (time frame: up to 6 months). 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?
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 14 Apr 2017.