Osteoarthritis of the KneePhase 4NCT01290497
Efficacy and Safety of 3 Different Dosage Regimens of Hyaluronic Acid in Patients With Knee Osteoarthritis (OA)
A Phase 4 study testing Hyaluronic acid 5 x 2.5 ml, Hyaluronic acid 1 x 5 ml and Hyaluronic acid 2 x 5 ml in people with Osteoarthritis of the Knee, run by Tedec-Meiji Farma, S.A. at 1 site in Spain.
Trial summary
The main objective is the comparison of three different dosage regimens 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 5 x 2.5 ml, Hyaluronic acid 1 x 5 ml and Hyaluronic acid 2 x 5 ml
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2010to Nov 2011
- Phase
- Phase 4
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient>45 years of age diagnosed with primary osteoarthritis according to ACR and Kellgren criteria
- Knee pain ≥ 55 mm and ≤90 mm measured by Visual Analogue Scale (VAS) 100 mm
- Ability to understand and follow study procedures
- Written informed consent
Who cannot join
- Patients with secondary osteoarthritis of the knee according to ACR criteria.
- Severe inflammation of the knee diagnosed by physical examination or a sedimentation speed rate < 40 mm/h and serum rheumatoid factor titre < 1:40
- Patients having previously received surgery, including arthroscopy
- Patients with joint inflammatory disease (spondilitis, systemic rheumatoid arthritis), microcrystalline arthropathies (chondrocalcinosis, gout, fibromyalgia) and significant osteoarthritis symptoms in other joints apart from the knee, and which require pharmacological treatment
- Previous administration of any of the following treatments: hyaluronic acid ia (last year); steroids i.a. or joint lavage (last 3 months), glucosamine sulfate, chondroitin sulfate or diacerein (last 3 months), NSAIDs (last 14 days), any investigational drug (last month) or its administration during this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot, Unicentre, Randomized, Parallel, Controlled Study to Evaluate the Efficacy and Safety of Three Different Intraarticular Dosage Regimens of Adant® in Patients With Osteoarthritis of the Knee
The main objective is the comparison of three different dosage regimens of hyaluronic acid in the treatment of osteoarthritis of the knee.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Hyaluronic acid 5 x 2.5 ml, Hyaluronic acid 1 x 5 ml, Hyaluronic acid 2 x 5 ml
- 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 acid 5 x 2.5 mlDrug
5 intraarticular administration of Adant® 2.5ml with one week interval between administrations (standard treatment)
Hyaluronic acid 1 x 5 mlDrug
1 intraarticular administration of Adant® 5ml
Hyaluronic acid 2 x 5 mlDrug
2 intraarticular administration of Adant® 5ml with a two-week interval between administrations.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid 5 x 2.5 ml | Active comparator | Not described Receives: Drug: Hyaluronic acid 5 x 2.5 ml |
| Hyaluronic acid 1 X 5 ml | Experimental | Not described Receives: Drug: Hyaluronic acid 1 x 5 ml |
| Hyaluronic acid 2 x 5 ml | Experimental | Not described Receives: Drug: Hyaluronic acid 2 x 5 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective is to evaluate the efficacy of different dosage regimens of intraarticular Hyaluronic Acid 5 ml (Adant®)compared to a standard treatment (2.5ml X 5 i.a) in patients with osteoarthritis of the knee.
Primary endpoint: Pain, Function and patient's assessment according to OARSI 2004 responder criteria.
Every patient who has received 100% of injections by the end of the study and has fulfilled the follow-up visits will be considered evaluable.
The percentage of patients in each group who do not complete the study due to lack of efficacy will be evaluated.
Measured: 1 year
Secondary outcomes (1)
To evaluate the safety of the different dosage regimens
Safety endpoints: Recording of adverse events and physical examination
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionOct 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tedec-Meiji Farma, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alejandro Escudero, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290497
- Sponsor's protocol ID
- TM-ME3710/403
- Other IDs
- 2010-021633-31
- Status last verified
- Feb 2014
- First submitted
- 2 Feb 2011
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Unicentre, Randomized, Parallel, Controlled Study to Evaluate the Efficacy and Safety of Three Different Intraarticular Dosage Regimens of Adant® in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT01290497
- Acronym / sponsor ID
- TM-ME3710/403
- Conditions
- Osteoarthritis of the Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Tedec-Meiji Farma, S.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 7 Feb 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.
The main objective is the comparison of three different dosage regimens of hyaluronic acid in the treatment of osteoarthritis of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid 5 x 2.5 ml | Active comparator | Drug: Hyaluronic acid 5 x 2.5 ml |
| Hyaluronic acid 1 X 5 ml | Experimental | Drug: Hyaluronic acid 1 x 5 ml |
| Hyaluronic acid 2 x 5 ml | Experimental | Drug: Hyaluronic acid 2 x 5 ml |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Outpatient>45 years of age diagnosed with primary osteoarthritis according to ACR and Kellgren criteria
- Knee pain ≥ 55 mm and ≤90 mm measured by Visual Analogue Scale (VAS) 100 mm
- Ability to understand and follow study procedures
- Written informed consent
Key exclusion criteria (5 listed)
- Patients with secondary osteoarthritis of the knee according to ACR criteria.
- Severe inflammation of the knee diagnosed by physical examination or a sedimentation speed rate < 40 mm/h and serum rheumatoid factor titre < 1:40
- Patients having previously received surgery, including arthroscopy
- Patients with joint inflammatory disease (spondilitis, systemic rheumatoid arthritis), microcrystalline arthropathies (chondrocalcinosis, gout, fibromyalgia) and significant osteoarthritis symptoms in other joints apart from the knee, and which require pharmacological treatment
- Previous administration of any of the following treatments: hyaluronic acid ia (last year); steroids i.a. or joint lavage (last 3 months), glucosamine sulfate, chondroitin sulfate or diacerein (last 3 months), NSAIDs (last 14 days), any investigational drug (last month) or its administration during this 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 acid 5 x 2.5 ml5 intraarticular administration of Adant® 2.5ml with one week interval between administrations (standard treatment) | Drug | Hyaluronic acid 5 x 2.5 ml |
| Hyaluronic acid 1 x 5 ml1 intraarticular administration of Adant® 5ml | Drug | Hyaluronic acid 1 X 5 ml |
| Hyaluronic acid 2 x 5 ml2 intraarticular administration of Adant® 5ml with a two-week interval between administrations. | Drug | Hyaluronic acid 2 x 5 ml |
Primary outcome
The main objective is to evaluate the efficacy of different dosage regimens of intraarticular Hyaluronic Acid 5 ml (Adant®)compared to a standard treatment (2.5ml X 5 i.a) in patients with osteoarthritis of the knee.
Time frame: 1 year
Primary endpoint: Pain, Function and patient's assessment according to OARSI 2004 responder criteria. Every patient who has received 100% of injections by the end of the study and has fulfilled the follow-up visits will be considered evaluable. The percentage of patients in each group who do not complete the study due to lack of efficacy will be evaluated.
1 secondary outcome
To evaluate the safety of the different dosage regimens
Time frame: 1 year
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 3 Mar 2014.
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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.
Alejandro Escudero principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyaluronic acid 5 x 2.5 ml, Hyaluronic acid 1 x 5 ml and Hyaluronic acid 2 x 5 ml in people with Osteoarthritis of the Knee, run by Tedec-Meiji Farma, S.A. at 1 site in Spain.
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 3 Mar 2014. 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 Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The main objective is to evaluate the efficacy of different dosage regimens of intraarticular Hyaluronic Acid 5 ml (Adant®)compared to a standard treatment (2.5ml X 5 i.a) in patients with osteoarthritis of the knee. (time frame: 1 year). 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 3 Mar 2014.