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Osteoarthritis of KneePhase 3NCT02122601

A Clinical Trial to Evaluate the Safety and Efficacy of Retreatment With Intra-articular LBSA0103 Injections in the Patients With Osteoarthritis of the Knee

A Phase 3 study testing LBSA0103 (BDDE cross-linked sodium hyaluronate gel) in people with Osteoarthritis of Knee, run by LG Life Sciences at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the safety and efficacy of LBSA0103 (BDDE cross-linked sodium hyaluronate gel) when it is administered for the second time 26 weeks after its first administration in patients with osteoarthritis of the knee. The Safety and efficacy of 26weeks after its first administration will be also evaluated. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Osteoarthritis of Knee
What is being tested?
LBSA0103 (BDDE cross-linked sodium hyaluronate gel)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
1 siteSouth Korea
Study dates
Apr 2014to May 2015
Phase
Phase 3
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A patient diagnosed with one or both knee osteoarthritis based on the clinical diagnosis criteria of the American College of Rheumatology (ACR) (there should be knee pain and in addition, at least three of the following six conditions have to be satisfied: 1. Over 50 years of age 2. Less than 30 minutes of morning stiffness 3. Crepitus on active motion 4 Bony tenderness 5. Bony enlargement 6. No palpable warmth of synovium)
  • Adult male and female patients of age 40 or above diagnosed with knee osteoarthritis with the Kellgren \& Lawrence Grade of I - III by x-ray within 6 months before the screening visit (based on -2 weeks) or by x-ray at the screening visit
  • A patient who has at least one knee with a weight-bearing pain value of 40 mm or more when weight-bearing pain (100 mm-VAS) is measured
  • A patient taking aspirin at a low dose (300 mg or less per day) who is willing to take aspirin constantly at the same dose until the clinical study is completed and can refrain from taking aspirin within 24 hours before each visit.
  • A patient who can walk without depending on a walking aid such as walker, cane, etc. but if the patient has been using a walking aid on a daily basis from six months ago, the patient assessment can be conducted while including the walking aid and the walking aid must be used in the same way until the study is completed.
  • A patient who can understand the meanings of an efficacy measurement questionnaire well and complete it
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  • A patient who heard an explanation about the purpose, method, effects, etc. of the clinical study and whose informed consent form has been signed by him/herself or subject's representative
  • A patient who falls under one of the following four cases
  • Patients who are surgically infertile
  • Post-menopausal women who are above 45 years of age and 2 years after the last menstruation
  • Fertile premenopausal female patients or male patients without having a surgical sterilization who have agreed to use at least two birth control methods (including one of barrier methods) for at least 13 weeks after the administration of the last investigational product to avoid pregnancy
  • Barrier methods: Condom, Diaphragm, Cervical cap(Pessary), Spermicide
  • Hormonal methods: Pills, Injection(Depot), Skin patch, Hormonal implant(Implanon), Vaginal ring
  • Intrauterine Devices(IUDs): Cooper IUD(Loop), Hormonal IUD(Mirena)
  • Natural methods: Basic body temperature, Ovulation period, Coitus interruptus, Abstinent
  • A patient who discontinued analgesics, NSAIDs, condroichin sulfate/glucosamine and physical therapy or oriental medical treatment (acupuncture, cubbing therapy, moxa treatment) within 2 weeks before the administration (washout period) and has a will to discontinue them from the screening visit of the study to the end (however, 300 mg less per day of aspirin and acetaminophen, a rescue therapy, can be taken)
  • A patient who didn't take any analgesic including aspirin and acetaminophen within 24 hours before the administration

Who cannot join

  • Body mass index > 32
  • A patient with rheumatoid arthritis, or other inflammatory or metabolic arthritis
  • A patient with infection or severe inflammation at the joint like septic arthritis
  • A patient with infection or skin disease at the site of administration
  • A patient with secondary knee osteoarthritis caused by ochronosis, hemochromatosis, systemic disease, etc.
  • A patient with a very painful musculoskeletal disease such as Sudek's atrophy, Paget's disease, or spinal disc herniation
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  • A poly-artricular patient with a severe osteoarthritis symptom at other site (e.g., hip joint, etc.) which can have an effect on the assessment of the pain for knee joint
  • Patients diagnosed with knee osteoarthritis with the Kellgren \& Lawrence Grade of IV in X-ray within 6 months before the screening visit (based on -2 weeks) or X-ray at the screening visit
  • A patient showing a clear loss in the joint space of patello-femoral joint (PFJ) in X-ray
  • A patient who took following drug before the administration of investigational product (baseline visit):
  • A patient who had HA at the target knee joint within the last 6 months
  • A patient who was given an intra-articular knee joint injection with steroidal agent within the last 3 months
  • A patient who used steroidal agent systemically by oral administration within the last 1 month (However, except for inhalant)
  • A patient with moderate to severe joint effusion which was found to be positive through patella tap test, etc.
  • A patient with alcoholism and alcoholic liver disease
  • A patient with a serious heart disease or hepatic and renal dysfunction or a patient who showed the following laboratory test value:
  • AST, ALT ≥ 3 times the upper limit of normal range
  • Serum creatinine > 2mg/dl
  • A patient who had a surgical procedure including arthroscopy on the target knee within the last 1 year (In case of a patient who had a history of joint surgery on other knee or hip joint, the patient shall be excluded if the assessment of the target knee is likely to be affected by that. )
  • A patient who has a history of knee replacement surgery on the target knee joint
  • A patient who does highly intensive aerobic exercise or heavy anaerobic exercise such as running or weight training which can have an effect on knee joint.
  • A patient who needs to use an anticoagulant agent concurrently (However, except for aspirin of 300 mg or less per day)
  • A patient who is mentally ill or can't understand the purpose and method of this clinical study
  • A patient who shows hypersensitivity reaction to the investigational product of this clinical study
  • A patient who is participating in other clinical study after having enrolled in this study, or participated in other clinical study within 1 month before the enrollment in this clinical study
  • A patient who is considered to have a difficulty undergoing the clinical study at the discretion of the Principal Investigator
  • A patient who was given one of the following drugs based on the day of administration:
  • A patient who was given anesthetic within the last 48 hours
  • A patient who took analgesics including acetaminophen and aspirin within the last 24 hour

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

Official title: An Open-label, Single Arm, Multi-center, Phase 3 Study to Evaluate the Safety and Efficacy of Retreatment With Intra-articular LBSA0103 Injections in the Patients With Osteoarthritis of the Knee

To assess the safety and efficacy of LBSA0103 (BDDE cross-linked sodium hyaluronate gel) when it is administered for the second time 26 weeks after its first administration in patients with osteoarthritis of the knee.

The Safety and efficacy of 26weeks after its first administration will be also evaluated.

Being tested
LBSA0103 (BDDE cross-linked sodium hyaluronate gel)
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LBSA0103 (BDDE cross-linked sodium hyaluronate gel)Drug

Study groups in NCT02122601
Study groupRoleWhat they receive
LBSA0103Othersingle arm , LBSA0103 only
Receives: Drug: LBSA0103 (BDDE cross-linked sodium hyaluronate gel)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events for 13 weeks after the first and second administration

    Measured: Week 13 from each baseline

Secondary outcomes (15)

  1. Local reactions at injection site after the first and second administration

    Measured: Week 13 from each baseline

  2. Adverse Events during total clinical study period

    Measured: 0, 13, 26, 39 weeks

  3. Vital signs

    Measured: 0, 13, 26, 39 weeks

  4. Laboratory exam

    Measured: 0, 13, 26, 39 weeks

  5. Change of Weight-bearing pain (100mm-VAS) from baseline

    Measured: 0, 13, 26, 39 weeks

  6. Change of WOMAC-likert assessment: Pain, Function, stiffness, Total score from baseline

    Measured: 0, 13, 26, 39 weeks

  7. Change of Patient Global Assessment (100mm-VAS) from baseline

    Measured: 0, 13, 26, 39 weeks

  8. Change of Investigator Global Assessment (100mm-VAS) from baseline

    Measured: 0, 13, 26, 39 weeks

  9. Change of rest pain(100mm-VAS) from baseline

    Measured: 0, 13, 26, 39 weeks

  10. Change of night pain(100mm-VAS) from baseline

    Measured: 0, 13, 26, 39 weeks

  11. Change of motion pain(100mm-VAS) from baseline

    Measured: 0, 13, 26, 39 weeks

  12. Physical assessment: swelling on knee joint, tenderness on pressure and the range of motion of knee joint

    Measured: 0, 13, 26, 39 weeks

  13. The Percentage of Subjects who took the Rescue Medicine (ACETAMINOPHEN REGIMEN) and Total Consumption

    Measured: 0, 13, 26, 39 weeks

  14. Responder Rate of subjects who showed a reduction by at least 20 mm or an improvement by at least 40% in the Weight-bearing pain (100 mmVAS)

    Measured: 13, 26, 39 weeks

  15. OMERACT-OARSI responder rate

    Measured: 13, 26, 39 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02122601
Sponsor's protocol ID
LG-HACL013
Status last verified
Sep 2015
First submitted
16 Apr 2014
Last updated
9 Sep 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LBSA0103 (BDDE cross-linked sodium hyaluronate gel) in people with Osteoarthritis of Knee, run by LG Life Sciences 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 17 inclusion and 29 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 9 Sep 2015. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Adverse events for 13 weeks after the first and second administration (time frame: Week 13 from each baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02122601.

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 9 Sep 2015.

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