Hip OsteoarthritisNCT05938088
Mirogabalin for Total Hip Arthroplasty
A study testing Arm I (mirogabalin group) in people with Hip Osteoarthritis, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to confirm the analgesic effect of mirogabalin in patients undergoing unilateral hip arthroplasty. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Arm I (mirogabalin group)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jul 2023to 28 Jun 2025
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty
- American Society of Anesthesiologists class 1-3
Who cannot join
- Major prior ipsilateral open hip surgery
- Allergies to drugs used in research
- Difficult to manage diabetes mellitus (including insulin dependence)
- Chronic use of gabapentin or pregabalin (regular use for more than 3 months)
- Patients taking cimetidine, probenecid, or lorazepam
- Patients with moderate or severe hepatic impairment (AST/ALT 2.5 times or more of the upper limit of normal)
Show all 9Show fewer
- Estimated glomerular filtration rate < 60 mL/min/1.73m2
- Dependence on opioids
- In the case of subjects who cannot read the consent form (e.g. illiterate, foreigners, etc.)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital
Seoul
Ji Yeong Kim, 82-2-2019-4601
About this study
Official title: Mirogabalin and Pain After Total Hip Arthroplasty: a Double-blind, Randomized, Placebo-controlled Trial
The purpose of this study is to confirm the analgesic effect of mirogabalin in patients undergoing unilateral hip arthroplasty.
- Conditions
- Hip Osteoarthritis
- Being tested
- Arm I (mirogabalin group), Arm II (placebo group)
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm I (mirogabalin group)Drug
Take two capsules of Mirogabalin 5 mg within 30 minutes before going to the operating room. Patients take 5 mg of mirogabalin twice daily at 12-hour intervals until POD 7 days.
Arm II (placebo group)Drug
It is performed in the same way as Arm l.
| Study group | Role | What they receive |
|---|---|---|
| mirogabalin group | Experimental | perioperative mirogabalin Receives: Drug: Arm I (mirogabalin group) |
| placebo group | Sham comparator | placebo Receives: Drug: Arm II (placebo group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
numeric rating scale at flexion
A score of 0 indicates no pain and a score of 10 indicates maximum pain.
Measured: postoperative day 1
Secondary outcomes (1)
numeric rating scale at flexion
A score of 0 indicates no pain and a score of 10 indicates maximum pain.
Measured: up to 3 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start20 Jul 2023
- Primary completion28 Jun 2025 (estimated)
- Study completion28 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do-Hyeong Kim, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938088
- Sponsor's protocol ID
- 3-2023-0151
- Status last verified
- Aug 2023
- First submitted
- 29 Jun 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirogabalin and Pain After Total Hip Arthroplasty: a Double-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05938088
- Acronym / sponsor ID
- 3-2023-0151
- Conditions
- Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 28 Jun 2025 (estimated)
- Study completion
- 28 Jun 2025 (estimated)
- First posted
- 10 Jul 2023 (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.
The purpose of this study is to confirm the analgesic effect of mirogabalin in patients undergoing unilateral hip arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mirogabalin group | Experimental | Drug: Arm I (mirogabalin group)perioperative mirogabalin |
| placebo group | Sham comparator | Drug: Arm II (placebo group)placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty
- American Society of Anesthesiologists class 1-3
Key exclusion criteria (9 listed)
- Major prior ipsilateral open hip surgery
- Allergies to drugs used in research
- Difficult to manage diabetes mellitus (including insulin dependence)
- Chronic use of gabapentin or pregabalin (regular use for more than 3 months)
- Patients taking cimetidine, probenecid, or lorazepam
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 |
|---|---|---|
| Arm I (mirogabalin group)Take two capsules of Mirogabalin 5 mg within 30 minutes before going to the operating room. Patients take 5 mg of mirogabalin twice daily at 12-hour intervals until POD 7 days. | Drug | mirogabalin group |
| Arm II (placebo group)It is performed in the same way as Arm l. | Drug | placebo group |
Primary outcome
numeric rating scale at flexion
Time frame: postoperative day 1
A score of 0 indicates no pain and a score of 10 indicates maximum pain.
1 secondary outcome
numeric rating scale at flexion
Time frame: up to 3 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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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?
A study testing Arm I (mirogabalin group) in people with Hip Osteoarthritis, run by Gangnam Severance 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 2 inclusion and 9 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 Aug 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 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. 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.
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 Do-Hyeong Kim (02-2019-3555, BREADFANS@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numeric rating scale at flexion (time frame: postoperative day 1). 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 Aug 2023; AzTrials last refreshed its copy on 29 Oct 2026.