OsteoarthritisPhase 3GoOn MRINCT00750724
Efficacy Study of "Go On" in Magnetic Resonance Imaging (MRI) Improvement in Osteoarthritis (OA) Knee
A Phase 3 study testing 25 mg sodium hyaluronate "GO ON" and normal saline,2 ml., intraarticular weekly for 5 weeks in people with Osteoarthritis, run by Khon Kaen University at 1 site in Thailand.
Trial summary
OA knee is a common degenerative diseases of the joint. There are many methods to treat this condition. Hyaluronic acid is one of the recomended treatment of OA knee. There is no any study on MRI change after injection hyaluronic acid. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- 25 mg sodium hyaluronate "GO ON" and normal saline,2 ml., intraarticular weekly for 5 weeks
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2008to Oct 2009
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Ambulatory non pregnant females and males 40-<80 years of age.
- Subjects who withdraw pain medication or nutritional supplements for symptom relief for OA hand for a total of at least 30 days before screening visit 0.
- Pain at or below 40 mm on a 100 mm VAS in the index knee joints.
- A documented diagnosis of OA of the knee joint, or meeting American College of Rheumatology (ACR) clinical criteria for classification of idiopathic (primary) OA for at least 6 months prior to screening.
- Subject has been documented radiographic evidence of OA of the knees from the screening Visit radiograph of grade 2 or 3 according to Kellgren and Lawrence Radiographic Grading.
- Subject has no any contraindication for MRI
- Subject is able to understand and complete pain/function, global arthritis evaluation, and health outcome assessment.
Who cannot join
- Subjects with history of hypersensitivity to hyaluronate.
- Subjects with skin lesion at the knee joint.
- A history of knee surgery within 6 months prior to screening V0.
- Significant prior injury to the knee joint within 12 months prior to screening V0.
- Disease of the spine or other lower extremity joints of sufficient degree to affect the knee joint.
- Treatment with other drugs potentially affecting bone or cartilage metabolism as described below:
- chronic systematic corticosteroids
- Diacerin or glucosamine treatment within the last 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Study GoON and MRI Improvement in OA Knee
OA knee is a common degenerative diseases of the joint.
- There are many methods to treat this condition.
- Hyaluronic acid is one of the recomended treatment of OA knee.
- There is no any study on MRI change after injection hyaluronic acid.
- The Hypothesis is 25 mg of sodium hyaluronate (2.5 ml) would preserve the joint space in patient with osteoarthritis of the knee compared to placebo .
Read the detailed description
This will be the phase III randomized, double-blind, placebo-controlled trial of 52 weeks duration designed to evaluate the efficacy of sodium hyaluronate to placebo (saline), in adult with OA of the knee joints. Randomization will be stratified by Kellgren-Lawrence(KL) grade (garde2 or 3), by subjects X-ray. A total of 60 subjects are planed for enrollment in this study. The study will be conducted over approximately 52 weeks.
- Conditions
- Osteoarthritis
- Being tested
- 25 mg sodium hyaluronate "GO ON", normal saline,2 ml., intraarticular weekly for 5 weeks
- Keywords
- Hyaluronic acid,, OA knee,, MRI
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25 mg sodium hyaluronate "GO ON"Drug
25 mg sodium hyaluronate, 2 ml., intraarticular weekly for 5 weeks
normal saline,2 ml., intraarticular weekly for 5 weeksDrug
| Study group | Role | What they receive |
|---|---|---|
| B | Placebo comparator | 2 ml of Normal saline intraarticular injection to the knee joint weekly for 5 weeks Receives: Drug: normal saline,2 ml., intraarticular weekly for 5 weeks |
| A | Experimental | 2 ml of 25 mg sodium hyaluronate intraarticular injection to the knee joint weekly for 5 weeks Receives: Drug: 25 mg sodium hyaluronate "GO ON" |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI will be analysed with semiquantitative whole organ scoring method (WORMS) c
Measured: 6 months
Secondary outcomes (1)
WOMAC, VAS, side effects
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Investigators
- Weerachai Kosuwon, Professor, Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750724
- Sponsor's protocol ID
- Faculty of Medicine, Khon Kaen
- Acronym
- GoOn MRI
- Status last verified
- Jul 2009
- First submitted
- 9 Sep 2008
- Last updated
- 26 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study GoON and MRI Improvement in OA Knee
- ClinicalTrials.gov ID
- NCT00750724
- Acronym / sponsor ID
- GoOn MRI / Faculty of Medicine, Khon Kaen
- Conditions
- Osteoarthritis
- Keywords
- Hyaluronic acid,, OA knee,, MRI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 10 Sep 2008 (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.
OA knee is a common degenerative diseases of the joint.
- There are many methods to treat this condition.
- Hyaluronic acid is one of the recomended treatment of OA knee.
- There is no any study on MRI change after injection hyaluronic acid.
- The Hypothesis is 25 mg of sodium hyaluronate (2.5 ml) would preserve the joint space in patient with osteoarthritis of the knee compared to placebo .
Detailed description
This will be the phase III randomized, double-blind, placebo-controlled trial of 52 weeks duration designed to evaluate the efficacy of sodium hyaluronate to placebo (saline), in adult with OA of the knee joints. Randomization will be stratified by Kellgren-Lawrence(KL) grade (garde2 or 3), by subjects X-ray. A total of 60 subjects are planed for enrollment in this study. The study will be conducted over approximately 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Placebo comparator | Drug: normal saline,2 ml., intraarticular weekly for 5 weeks2 ml of Normal saline intraarticular injection to the knee joint weekly for 5 weeks |
| A | Experimental | Drug: 25 mg sodium hyaluronate "GO ON"2 ml of 25 mg sodium hyaluronate intraarticular injection to the knee joint weekly for 5 weeks |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects who are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Ambulatory non pregnant females and males 40-<80 years of age.
- Subjects who withdraw pain medication or nutritional supplements for symptom relief for OA hand for a total of at least 30 days before screening visit 0.
- Pain at or below 40 mm on a 100 mm VAS in the index knee joints.
- A documented diagnosis of OA of the knee joint, or meeting American College of Rheumatology (ACR) clinical criteria for classification of idiopathic (primary) OA for at least 6 months prior to screening.
Key exclusion criteria (8 listed)
- Subjects with history of hypersensitivity to hyaluronate.
- Subjects with skin lesion at the knee joint.
- A history of knee surgery within 6 months prior to screening V0.
- Significant prior injury to the knee joint within 12 months prior to screening V0.
- Disease of the spine or other lower extremity joints of sufficient degree to affect the knee joint.
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 |
|---|---|---|
| 25 mg sodium hyaluronate "GO ON"25 mg sodium hyaluronate, 2 ml., intraarticular weekly for 5 weeks | Drug | A |
| normal saline,2 ml., intraarticular weekly for 5 weeks | Drug | B |
Primary outcome
MRI will be analysed with semiquantitative whole organ scoring method (WORMS) c
Time frame: 6 months
1 secondary outcome
WOMAC, VAS, side effects
Time frame: 14 months
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 26 May 2010.
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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.
Weerachai Kosuwon, Professor principal investigator
Khon Kaen University
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 25 mg sodium hyaluronate "GO ON" and normal saline,2 ml., intraarticular weekly for 5 weeks in people with Osteoarthritis, run by Khon Kaen University at 1 site in Thailand.
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 8 inclusion and 8 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 26 May 2010. 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 Thailand. 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.
What does the primary outcome measure?
MRI will be analysed with semiquantitative whole organ scoring method (WORMS) c (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2010.