NCT05266027

Brief 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. 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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 6, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2022

Completed
Last Updated

March 27, 2023

Status Verified

November 1, 2022

Enrollment Period

8 months

First QC Date

February 20, 2022

Last Update Submit

March 23, 2023

Conditions

Arthropathy of Knee Joint

Outcome Measures

Primary Outcomes (11)

  • The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)

    morphine consumption amount

    Post operation Day1

  • The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)

    morphine consumption amount

    Post operation Day2

  • The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)

    morphine consumption amount

    Post operation Day3

  • The level of pain index (Visual Analog Scale)

    pain level, Visual Analog Scale higher scores mean a worse outcome, 0\~10

    Baseline

  • The level of pain index (Visual Analog Scale)

    pain level, Visual Analog Scale higher scores mean a worse outcome, 0\~10

    Post operation Day1

  • The level of pain index (Visual Analog Scale)

    pain level, Visual Analog Scale higher scores mean a worse outcome, 0\~10

    Post operation Day2

  • The level of pain index (Visual Analog Scale)

    pain level, Visual Analog Scale higher scores mean a worse outcome, 0\~10

    Post operation Day3

  • The level of pain index (Visual Analog Scale)

    pain level, Visual Analog Scale higher scores mean a worse outcome, 0\~10

    Post operation Day4

  • The level of pain index (Visual Analog Scale)

    pain level, Visual Analog Scale higher scores mean a worse outcome, 0\~10

    Post operation Day5

  • The level of pain index (Visual Analog Scale)

    pain level, Visual Analog Scale higher scores mean a worse outcome, 0\~10

    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

    Post operation 6 weeks

Secondary Outcomes (3)

  • knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)

    Baseline

  • knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)

    Post operation 2 weeks

  • knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)

    Post operation 6 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Nalbuphine Sebacate (Naldebain) intramuscular injection

Drug: Nalbuphine Sebacate (Naldebain)

Placebo Group

PLACEBO COMPARATOR

Placebo medication intramuscular injection

Drug: Placebo medication

Interventions

Nalbuphine Sebacate (Naldebain)DRUG

Nalbuphine Sebacate (Naldebain) 2mL/150mg would be intramuscularly injected during knee arthroplasty surgery.

Experimental Group
Placebo medicationDRUG

Placebo medication, Nalbuphine Sebacate not contained

Placebo Group

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age at least 50 years old, not exceed 100 years old
  • Diagnosed Primary Knee Osteoarthritis accepted Knee Arthroplasty

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

Location

Study Officials

  • Hsuan-Ti Huang, M.D.

    Kaohsiung Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2022

First Posted

March 4, 2022

Study Start

April 6, 2022

Primary Completion

November 28, 2022

Study Completion

November 28, 2022

Last Updated

March 27, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)