Osteoarthritis of the KneePhase 3NCT01510535
Efficacy and Safety of LBSA0103 Versus Hyruan Plus Injection in Patients With Knee Osteoarthritis
A Phase 3 study testing Hyruan Plus and LBSA0103 in people with Osteoarthritis of the Knee, run by LG Life Sciences at 1 site in South Korea.
Trial summary
The purpose of this study is to compare efficacy and safety of intra-articular LBSA0103 once versus intra-articular hyaluronic acid injections (Hyruan Plus Injection) once weekly for 3 weeks in the treatment of patients with osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Hyruan Plus and LBSA0103
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 287 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Oct 2012
- 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
- Over 40 years of age
- Kellgren \& Lawrence grade I-III
- If there is more than one knee having a weight bearing pain of at least 40mm evaluated by 100mm VAS
- Be willing to discontinue all nonsteroidal anti-inflammatory drugs(NSAIDs), analgesics, condroichin sulfate/glucosamine or physical therapy for the duration of the study
Who cannot join
- Body mass index > 32
- Have rheumarthritis
- Patients who have a weight-bearing pain of less than 40mm on both knees when measured by 100mm-VAS
- Have Sudek's atrophy, Paget's disease, Spinal disc herniation
- Kellgren \& Lawrence Grade IV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Double-blind, Active-controlled, Parallel-group, Randomized, Multi-center Study to Compare Efficacy and Safety of LBSA0103 Once Versus Hyruan Plus Injection Once Weekly for 3weeks in the Treatment of Patients With Osteoarthritis of the Knee
The purpose of this study is to compare efficacy and safety of intra-articular LBSA0103 once versus intra-articular hyaluronic acid injections (Hyruan Plus Injection) once weekly for 3 weeks in the treatment of patients with osteoarthritis of the knee.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Placebo, Hyruan Plus, LBSA0103
- Keywords
- Osteoartritis, Knee, LBSA0103, Hyruan Plus Inj.
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
First 2 weeks Placebo(2ml) once weekly in experimental group
Hyruan PlusDrug
Hyruan Plus Inj. (2ml)once weekly for 3 weeks in control group
LBSA0103Drug
at third week LBSA0103(60mg) once in experimental group
| Study group | Role | What they receive |
|---|---|---|
| Placebo and then LBSA0103 | Experimental | The experimental group receive once weekly for 2 weeks intraarticular injections of Placebo(saline). And then, they receive once intraarticular injections of LBSA0103 into the target knee. Receives: Drug: Placebo; Drug: LBSA0103 |
| Hyruan Plus | Active comparator | The control group received once weekly for 3 weeks intraarticular injections of Hyruan Plus Inj. into the target knee. Receives: Drug: Hyruan Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight-bearing pain
using 100mm-VAS
Measured: 12 weeks after the last injection
Secondary outcomes (4)
Weight-bearing pain
using 100mm-VAS
Measured: 1,6 weeks after the last injection
WOMAC-likert assessment
Pain, Function, Stiffness, Total score
Measured: 1,6,12 weeks after the last injection
Patient Global Assessment
using 100mm-VAS
Measured: 1,6,12 weeks after the last injection
Investigator Global Assessment
using 100mm-VAS
Measured: 1,6,12 weeks after the last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionMar 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510535
- Sponsor's protocol ID
- LG-HACL010
- Status last verified
- Jan 2013
- First submitted
- 6 Jan 2012
- Last updated
- 17 Jan 2013
- Results posted
- No
Publications
Ha CW, Park YB, Choi CH, Kyung HS, Lee JH, Yoo JD, Yoo JH, Choi CH, Kim CW, Kim HC, Oh KJ, Bin SI, Lee MC. Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double-blind, randomized, multi-center, non-inferiority study. BMC Musculoskelet Disord. 2017 May 26;18(1):223. doi: 10.1186/s12891-017-1591-4.
PubMed 28549436
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Double-blind, Active-controlled, Parallel-group, Randomized, Multi-center Study to Compare Efficacy and Safety of LBSA0103 Once Versus Hyruan Plus Injection Once Weekly for 3weeks in the Treatment of Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT01510535
- Acronym / sponsor ID
- LG-HACL010
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoartritis, Knee, LBSA0103, Hyruan Plus Inj.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Jan 2012 (estimated)
- 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 compare efficacy and safety of intra-articular LBSA0103 once versus intra-articular hyaluronic acid injections (Hyruan Plus Injection) once weekly for 3 weeks in the treatment of patients with osteoarthritis of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo and then LBSA0103 | Experimental | Drug: Placebo, Drug: LBSA0103The experimental group receive once weekly for 2 weeks intraarticular injections of Placebo(saline). And then, they receive once intraarticular injections of LBSA0103 into the target knee. |
| Hyruan Plus | Active comparator | Drug: Hyruan PlusThe control group received once weekly for 3 weeks intraarticular injections of Hyruan Plus Inj. into the target knee. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 40 years of age
- Kellgren \& Lawrence grade I-III
- If there is more than one knee having a weight bearing pain of at least 40mm evaluated by 100mm VAS
- Be willing to discontinue all nonsteroidal anti-inflammatory drugs(NSAIDs), analgesics, condroichin sulfate/glucosamine or physical therapy for the duration of the study
Key exclusion criteria (5 listed)
- Body mass index > 32
- Have rheumarthritis
- Patients who have a weight-bearing pain of less than 40mm on both knees when measured by 100mm-VAS
- Have Sudek's atrophy, Paget's disease, Spinal disc herniation
- Kellgren \& Lawrence Grade IV
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 |
|---|---|---|
| PlaceboFirst 2 weeks Placebo(2ml) once weekly in experimental group | Drug | Placebo and then LBSA0103 |
| Hyruan PlusHyruan Plus Inj. (2ml)once weekly for 3 weeks in control group | Drug | Hyruan Plus |
| LBSA0103at third week LBSA0103(60mg) once in experimental group | Drug | Placebo and then LBSA0103 |
Primary outcome
Weight-bearing pain
Time frame: 12 weeks after the last injection
using 100mm-VAS
4 secondary outcomes
Weight-bearing pain
Time frame: 1,6 weeks after the last injection
WOMAC-likert assessment
Time frame: 1,6,12 weeks after the last injection
Patient Global Assessment
Time frame: 1,6,12 weeks after the last injection
Investigator Global Assessment
Time frame: 1,6,12 weeks after the last injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2013.
- Derived from this study: PubMed 28549436Ha CW, Park YB, Choi CH, Kyung HS, Lee JH, Yoo JD, Yoo JH, Choi CH, Kim CW, Kim HC, Oh KJ, Bin SI, Lee MC. Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double-blind, randomized, multi-center, non-inferiority study. BMC Musculoskelet Disord. 2017 May 26;18(1):223. doi: 10.1186/s12891-017-1591-4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyruan Plus and LBSA0103 in people with Osteoarthritis of the 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 4 inclusion and 5 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 17 Jan 2013. 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?
Weight-bearing pain (time frame: 12 weeks after the last injection). 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 NCT01510535, which also lists 1 linked publication.
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 17 Jan 2013.