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

NCT02122601 | Completed Phase 3

• 1 other identifier: LG-HACL013
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis of Knee

Outcome Measures

Primary Outcomes (1)

• Adverse events for 13 weeks after the first and second administration

  Week 13 from each baseline

Secondary Outcomes (15)

• Local reactions at injection site after the first and second administration

  Week 13 from each baseline

• Adverse Events during total clinical study period

  0, 13, 26, 39 weeks

• Vital signs

  0, 13, 26, 39 weeks

• Laboratory exam

  0, 13, 26, 39 weeks

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

  0, 13, 26, 39 weeks

Study Arms (1)

LBSA0103

OTHER

single arm , LBSA0103 only

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

Interventions

LBSA0103 (BDDE cross-linked sodium hyaluronate gel) DRUG

LBSA0103

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• LG Life Sciences: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 24, 2014
• Study Start: April 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: September 9, 2015

Record last verified: 2015-09

Locations

KR (1)