Osteoarthritis of the KneeNCT00669032
Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid in Patients With OA of the Knee
A study testing Hyaluronic acid in people with Osteoarthritis of the Knee, run by Tedec-Meiji Farma, S.A..
Trial summary
The main objective is the long-term comparison (3 years and 4 months) of the efficacy and safety of repeated intra-articular administration of hyaluronic acid in the treatment of osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Hyaluronic acid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 446 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient > 45 years of age
- Out-patient diagnosed with primary osteoarthritis of the femorotibial medial joint of the knee with clinical and radiological (Kellgren grade II-III) ACR diagnosis
- Joint Space Width (JSW) > 2mm
- Overall pain greater or equal to 55mm (VAS - Visual Analogue Scale 100mm) recorded in the knee,by the patient at any time during the week prior to the evaluation
Who cannot join
- Overweight patients (body mass index > 32).
- Pregnant and lactating women. Women of child-bearinge age not using effective contraception
- Patients who have received intra-articular hyaluronic acid within the previous year and/or intra-articular steroids or articular lavage in the chosen knee,within the previous 3 months prior to their inclusion in the study.
- AINE administration within the 14 days prior to their inclusion in the study.
- Administration of glucosamine sulphate, chondroitin sulphate and diacerein within the 3 months prior to their inclusion in the study.
- Immunocompromised patients or patients receiving systemic immunosuppressive therapy.
Show all 13Show fewer
- Patients with known sensitivity to HA, parcetamol or AINEs permitted as rescue medication.
- Patients who have received any investigational drug within 30 days prior to visit 1, or who are scheduled for the administration of an investigational drug other than the protocol product during this study.
- Patients with severely impaired central nervous system.
- Patients with coagulation alterations, despite receiving treatment.
- Patients with secondary osteoarthritis of the knee
- Patients having previously received surgery, including arthroscopy
- Patients with articular inflammatory disease
About this study
Official title: Random, Phase IV, Multicentre, Double Blind, Placebo Controlled, Parallel Study to Assess Long-term Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid (ADANT®) in Patients With Knee OA of the Knee
The main objective is the long-term comparison (3 years and 4 months) of the efficacy and safety of repeated intra-articular administration of hyaluronic acid in the treatment of osteoarthritis of the knee.
Read the detailed description
To evaluate the efficacy and safety of repeated injections of hyaluronic acid compared with placebo over a period of 40 months.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Hyaluronic acid, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidDevice
3 cycles of 5 hyaluronic acid injections, with a 6 month interval between each one. A 4th treatment cycle of five injections will be carried out at the end of one year
PlaceboOther
3 cycles of 5 saline solution injections, with a 6 month interval between each one. A 4th treatment cycle of five injections will be carried out at the end of one year
| Study group | Role | What they receive |
|---|---|---|
| hyaluronic acid | Experimental | Cycles of 5 injections of hyaluronic acid at specified intervals Receives: Device: Hyaluronic acid |
| Placebo | Placebo comparator | Cycles of 5 injections of saline at specified intervals Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responders OARSI 2004 at the End of Follow-up
Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at the end of follow-up. Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.
The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome.
Measured: 40 months
Secondary outcomes (11)
Responders OARSI 2004 at 7 Months Follow-up Visit
Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 7 months follow-up visit (6 months after first cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.
The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome.
Measured: 7 months (6 months after first cycle)
Responders OARSI 2004 at 14 Months Follow-up Visit
Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 14 months follow-up visit (6 months after second cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.
The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome.
Measured: 14 months (6 months after second cycle)
Responders OARSI 2004 at 21 Months Follow-up Visit
Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 21 months follow-up visit (6 months after third cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.
The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome.
Measured: 21 months (6 months after third cycle)
Responders OARSI 2004 at 27 Months Follow-up Visit
Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 27 months follow-up visit (12 months after third cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.
The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome.
Measured: 27 months (12 months after third cycle)
Responders OARSI 2004 at 34 Months Follow-up Visit
Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 34 months follow-up visit (6 months after fourth cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.
The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome.
Measured: 34 months (6 months after fourth cycle)
Pain or Function Scores Reduction 50% (20mm) at the End of Follow-up
Percentage of patients with a decrease in pain or physical function score of at least 50% and at least 20mm on the VAS at the end of follow-up.
The VAS is set between 0-100mm, higher values represent a worse outcome.
Measured: 40 months
Overall Pain Reduction 20% (10mm) at the End of Follow-up
Percentage of patients with a decrease in pain score of at least 20% or at least 10mm on the VAS at the end of follow-up.
The VAS is set between 0-100mm, higher values represent a worse outcome.
Measured: 40 months
Function Improvement 20% (10mm) at the End of Follow-up
Percentage of patients with a decrease in physical function score of at least 20% or at least 10mm on the VAS at the end of follow-up.
The VAS is set between 0-100mm, higher values represent a worse outcome.
Measured: 40 months
Patient's Global Assessment Increase 20% (10mm) at the End of Follow-up
Percentage of patients with an increase in the score of patient's global assessment by at least 20% and at least 10mm on the VAS at the end of follow-up.
The VAS is set between 0-100mm, higher values represent a better outcome.
Measured: 40 months
Percentage of Patients Who Consumed Rescue Medication for Osteoarthritis
Consumption of rescue medication (paracetamol/NSAID) for osteoarthritis throughout the study, an average of 40 months
Measured: Throughout the study, an average of 40 months
Mean Daily Dose of Paracetamol Consumption
Mean daily dose of paracetamol consumption throughout the study, an average of 40 months
Measured: Throughout the study, an average of 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startOct 2003
- Primary completionJul 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tedec-Meiji Farma, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Federico Navarro Sarabia, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669032
- Sponsor's protocol ID
- TM-ME3710/304
- Other IDs
- 2006-001854-28
- Status last verified
- Aug 2023
- First submitted
- 25 Apr 2008
- Last updated
- 28 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Navarro-Sarabia F, Coronel P, Collantes E, Navarro FJ, de la Serna AR, Naranjo A, Gimeno M, Herrero-Beaumont G; AMELIA study group. A 40-month multicentre, randomised placebo-controlled study to assess the efficacy and carry-over effect of repeated intra-articular injections of hyaluronic acid in knee osteoarthritis: the AMELIA project. Ann Rheum Dis. 2011 Nov;70(11):1957-62. doi: 10.1136/ard.2011.152017. Epub 2011 Aug 17.
PubMed 21852252
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Random, Phase IV, Multicentre, Double Blind, Placebo Controlled, Parallel Study to Assess Long-term Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid (ADANT®) in Patients With Knee OA of the Knee
- ClinicalTrials.gov ID
- NCT00669032
- Acronym / sponsor ID
- TM-ME3710/304
- Conditions
- Osteoarthritis of the Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- Tedec-Meiji Farma, S.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 29 Apr 2008 (estimated)
- Results
- Posted 15 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is the long-term comparison (3 years and 4 months) of the efficacy and safety of repeated intra-articular administration of hyaluronic acid in the treatment of osteoarthritis of the knee.
Detailed description
To evaluate the efficacy and safety of repeated injections of hyaluronic acid compared with placebo over a period of 40 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyaluronic acid | Experimental | Device: Hyaluronic acidCycles of 5 injections of hyaluronic acid at specified intervals |
| Placebo | Placebo comparator | Other: PlaceboCycles of 5 injections of saline at specified intervals |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient > 45 years of age
- Out-patient diagnosed with primary osteoarthritis of the femorotibial medial joint of the knee with clinical and radiological (Kellgren grade II-III) ACR diagnosis
- Joint Space Width (JSW) > 2mm
- Overall pain greater or equal to 55mm (VAS - Visual Analogue Scale 100mm) recorded in the knee,by the patient at any time during the week prior to the evaluation
Key exclusion criteria (13 listed)
- Overweight patients (body mass index > 32).
- Pregnant and lactating women. Women of child-bearinge age not using effective contraception
- Patients who have received intra-articular hyaluronic acid within the previous year and/or intra-articular steroids or articular lavage in the chosen knee,within the previous 3 months prior to their inclusion in the study.
- AINE administration within the 14 days prior to their inclusion in the study.
- Administration of glucosamine sulphate, chondroitin sulphate and diacerein within the 3 months prior to their inclusion in the study.
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 |
|---|---|---|
| Hyaluronic acid3 cycles of 5 hyaluronic acid injections, with a 6 month interval between each one. A 4th treatment cycle of five injections will be carried out at the end of one year | Device | hyaluronic acid |
| Placebo3 cycles of 5 saline solution injections, with a 6 month interval between each one. A 4th treatment cycle of five injections will be carried out at the end of one year | Other | Placebo |
Primary outcome
Responders OARSI 2004 at the End of Follow-up
Time frame: 40 months
Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at the end of follow-up. Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS. The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome.
11 secondary outcomes
Responders OARSI 2004 at 7 Months Follow-up Visit
Time frame: 7 months (6 months after first cycle)
Responders OARSI 2004 at 14 Months Follow-up Visit
Time frame: 14 months (6 months after second cycle)
Responders OARSI 2004 at 21 Months Follow-up Visit
Time frame: 21 months (6 months after third cycle)
Responders OARSI 2004 at 27 Months Follow-up Visit
Time frame: 27 months (12 months after third cycle)
Responders OARSI 2004 at 34 Months Follow-up Visit
Time frame: 34 months (6 months after fourth cycle)
Pain or Function Scores Reduction 50% (20mm) at the End of Follow-up
Time frame: 40 months
Overall Pain Reduction 20% (10mm) at the End of Follow-up
Time frame: 40 months
Function Improvement 20% (10mm) at the End of Follow-up
Time frame: 40 months
Patient's Global Assessment Increase 20% (10mm) at the End of Follow-up
Time frame: 40 months
Percentage of Patients Who Consumed Rescue Medication for Osteoarthritis
Time frame: Throughout the study, an average of 40 months
Mean Daily Dose of Paracetamol Consumption
Time frame: Throughout the study, an average of 40 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21852252Navarro-Sarabia F, Coronel P, Collantes E, Navarro FJ, de la Serna AR, Naranjo A, Gimeno M, Herrero-Beaumont G; AMELIA study group. A 40-month multicentre, randomised placebo-controlled study to assess the efficacy and carry-over effect of repeated intra-articular injections of hyaluronic acid in knee osteoarthritis: the AMELIA project. Ann Rheum Dis. 2011 Nov;70(11):1957-62. doi: 10.1136/ard.2011.152017. Epub 2011 Aug 17.
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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.
Federico Navarro Sarabia principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid in people with Osteoarthritis of the Knee, run by Tedec-Meiji Farma, S.A..
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 13 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 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Responders OARSI 2004 at the End of Follow-up (time frame: 40 months). 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 NCT00669032, 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 28 Aug 2023.