Mirogabalin for Total Hip Arthroplasty | NCT05938088

Studies
Mirogabalin for Total Hip Arthroplasty

NCT05938088

Sponsor

Gangnam Severance Hospital

Status

Unknown status

Last Update Posted

Aug 14, 2023Actual

Enrollment

56Estimated

Phase

Not Applicable

Conditions

Hip Osteoarthritis

Interventions

Arm I (mirogabalin group)
Arm II (placebo group)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2023Actual

Primary Completion Date

Jun 28, 2025Estimated

Completion Date

Jun 28, 2025Estimated

First Submitted Date

Jun 29, 2023

First Submission Date that Met QC Criteria

Jun 29, 2023

First Posted Date

Jul 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2023

Last Update Posted Date

Aug 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to confirm the analgesic effect of mirogabalin in patients undergoing unilateral hip arthroplasty.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mirogabalin group	Experimental	perioperative mirogabalin	Drug: Arm I (mirogabalin group)
placebo group	Sham Comparator	placebo	Drug: Arm II (placebo group)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
numeric rating scale at flexion	A score of 0 indicates no pain and a score of 10 indicates maximum pain.	postoperative day 1

Secondary Outcomes

Measure	Description	Time Frame
numeric rating scale at flexion	A score of 0 indicates no pain and a score of 10 indicates maximum pain.	up to 3 month after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty
American Society of Anesthesiologists class 1-3

Exclusion Criteria:

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)
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.)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Do-Hyeong Kim	Contact	02-2019-3555		BREADFANS@yuhs.ac

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gangnam Severance Hospital	Recruiting	Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D015207	Osteoarthritis, Hip

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided