OsteoarthritisPhase 3NCT01319461
Efficacy and Safety of Intraarticular Injections of Hyalgan in the Treatment of Osteoarthritis of the Knee
A Phase 3 study testing Hyalgan and sterile normal saline in people with Osteoarthritis, run by Med Pharma Co., Ltd. at 1 site in Taiwan.
Trial summary
Evaluate the efficacy and safety of Hyalgan, at a dose of 20mg/2ml administered as 5 intraarticular injections at weekly intervals, for the sustained relief of pain and amelioration of joint dysfunction in patients of OA of the knee. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Hyalgan and sterile normal saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2001to Jun 2002
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Male or female patients whose specific ages are > 50 years old, in general health. 2.Must be ambulatory (assistive devices allowed) 3.Patient was diagnosed as OA of knee joint by American College of Rheumatology (ACR) criteria ; [ ie,knee pain, and any one of the following:age>50 years,crepitus, or morning stiffness<30 minutes in duration ] 4.Radiographic confirmation of OA with Kellgren-Lawrence Ⅱ-Ⅲ score (mild to moderate)at the target joint (anterior-posterior views) with predominance in the tibia-femoral compartment 5.VAS score ≧40 mm for 50 foot of walking pain.
Who cannot join
- 1.Patients with severe degeneration of knee joint with marked joint narrowing, marked varus or valgus deformity of the knee greater than 12 o. 2.Patients with hepatic or renal failure, or other chronic severe diseases that can interfere with the outcome. 3.A known history of psychiatric diseases, significant neurological diseases, allergy or sensitivity to hyaluronic acid or avian protein. 4.Patients receive steroid intraarticular injection, anti-inflammatory agents less than two weeks. 5.Patients with joint disorders: inflammatory joint disease, specific arthropathy (chondrocalcinosis, joint effusion >30ml), severe axis deviations or instabilities, joint or skin infections, joint prostheses of the lower limbs, symptomatic hip. 6.Significant alcohol, drug or medication abuse as judged by the investigator. 7.Pregnancy determined by clinical evaluation or urine testing for nursing women and/or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm or Norplant). 8.Patients who have taken any other "investigational" drug within one month prior to the screening visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Intraarticular Injections of Hyalgan in the Treatment of Osteoarthritis of the Knee: a Randomized, Masked Observed, Double Blind, Placebo Controlled, Multicenter Clinical Trial.
Evaluate the efficacy and safety of Hyalgan, at a dose of 20mg/2ml administered as 5 intraarticular injections at weekly intervals, for the sustained relief of pain and amelioration of joint dysfunction in patients of OA of the knee.
- Conditions
- Osteoarthritis
- Being tested
- Hyalgan, sterile normal saline
- Keywords
- Osteoarthritis, Hyalgan
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyalganDevice
Patients will receive intraarticular injection of 20mg /2ml /syringe Hyalgan® once a week for 5 consecutive weeks.
sterile normal salineDevice
Patients will receive intraarticular injection of sterile normal saline once a week for 5 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| sterile normal saline injection | Placebo comparator | Not described Receives: Device: sterile normal saline |
| Hyalgan injection | Experimental | Not described Receives: Device: Hyalgan |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startMay 2001
- Primary completionJun 2002
- Study completionJun 2002
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 OsteoarthritisStudies 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, Care provider
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Med Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fidia Farmaceutici s.p.a.
- Investigators
- Lin Ching Tsai, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319461
- Sponsor's protocol ID
- UH-HYA-01-04
- Status last verified
- Mar 2011
- First submitted
- 18 Mar 2011
- Last updated
- 25 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huang TL, Chang CC, Lee CH, Chen SC, Lai CH, Tsai CL. Intra-articular injections of sodium hyaluronate (Hyalgan(R)) in osteoarthritis of the knee. a randomized, controlled, double-blind, multicenter trial in the Asian population. BMC Musculoskelet Disord. 2011 Oct 6;12:221. doi: 10.1186/1471-2474-12-221.
PubMed 21978211
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intraarticular Injections of Hyalgan in the Treatment of Osteoarthritis of the Knee: a Randomized, Masked Observed, Double Blind, Placebo Controlled, Multicenter Clinical Trial.
- ClinicalTrials.gov ID
- NCT01319461
- Acronym / sponsor ID
- UH-HYA-01-04
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Hyalgan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Med Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Fidia Farmaceutici s.p.a.
- Study start
- May 2001
- Primary completion
- Jun 2002 (actual)
- Study completion
- Jun 2002 (actual)
- First posted
- 21 Mar 2011 (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.
Evaluate the efficacy and safety of Hyalgan, at a dose of 20mg/2ml administered as 5 intraarticular injections at weekly intervals, for the sustained relief of pain and amelioration of joint dysfunction in patients of OA of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sterile normal saline injection | Placebo comparator | Device: sterile normal saline |
| Hyalgan injection | Experimental | Device: Hyalgan |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Male or female patients whose specific ages are > 50 years old, in general health. 2.Must be ambulatory (assistive devices allowed) 3.Patient was diagnosed as OA of knee joint by American College of Rheumatology (ACR) criteria ; [ ie,knee pain, and any one of the following:age>50 years,crepitus, or morning stiffness<30 minutes in duration ] 4.Radiographic confirmation of OA with Kellgren-Lawrence Ⅱ-Ⅲ score (mild to moderate)at the target joint (anterior-posterior views) with predominance in the tibia-femoral compartment 5.VAS score ≧40 mm for 50 foot of walking pain.
Key exclusion criteria (1 listed)
- 1.Patients with severe degeneration of knee joint with marked joint narrowing, marked varus or valgus deformity of the knee greater than 12 o. 2.Patients with hepatic or renal failure, or other chronic severe diseases that can interfere with the outcome. 3.A known history of psychiatric diseases, significant neurological diseases, allergy or sensitivity to hyaluronic acid or avian protein. 4.Patients receive steroid intraarticular injection, anti-inflammatory agents less than two weeks. 5.Patients with joint disorders: inflammatory joint disease, specific arthropathy (chondrocalcinosis, joint effusion >30ml), severe axis deviations or instabilities, joint or skin infections, joint prostheses of the lower limbs, symptomatic hip. 6.Significant alcohol, drug or medication abuse as judged by the investigator. 7.Pregnancy determined by clinical evaluation or urine testing for nursing women and/or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm or Norplant). 8.Patients who have taken any other "investigational" drug within one month prior to the screening visit.
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 |
|---|---|---|
| HyalganPatients will receive intraarticular injection of 20mg /2ml /syringe Hyalgan® once a week for 5 consecutive weeks. | Device | Hyalgan injection |
| sterile normal salinePatients will receive intraarticular injection of sterile normal saline once a week for 5 consecutive weeks. | Device | sterile normal saline injection |
Primary outcome
Not reported in the source record.
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 25 Mar 2011.
- Derived from this study: PubMed 21978211Huang TL, Chang CC, Lee CH, Chen SC, Lai CH, Tsai CL. Intra-articular injections of sodium hyaluronate (Hyalgan(R)) in osteoarthritis of the knee. a randomized, controlled, double-blind, multicenter trial in the Asian population. BMC Musculoskelet Disord. 2011 Oct 6;12:221. doi: 10.1186/1471-2474-12-221.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
Lin Ching Tsai, PhD principal investigator
National Taiwan University Hospital
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 Hyalgan and sterile normal saline in people with Osteoarthritis, run by Med Pharma Co., Ltd. at 1 site in Taiwan.
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 1 inclusion and 1 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 25 Mar 2011. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01319461, 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 25 Mar 2011.