Knee OsteoarthritisPhase 3MOSAICNCT01354145
Study of the Effect of Chondroitin Sulfate on Structural Changes in Knee Osteoarthritis Patients Assessed by MRI
A Phase 3 study testing Chondroitin sulfate and Celecoxib in people with Knee Osteoarthritis, run by Bioiberica at 5 sites in Canada.
Trial summary
The main purpose of this study is to compare the cartilage volume loss at the Baseline visit and after 24 months of treatment in patients treated with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily vs. patients treated with CELECOXIB 200 mg daily. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Chondroitin sulfate and Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 5 sitesCanada
- Study dates
- Jun 2011to Oct 2014
- Phase
- Phase 3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals of either sex, aged 40 years and more
- Subjects presenting primary OA of the knee according to ACR criteria with signs of synovitis (warmth, swelling or effusion
- OA of radiological stages 2 and 3 according to Kellgren-Lawrence;
- Minimum joint space width ≥2 mm in the medial femorotibial compartment on standing knee X-ray
- VAS of pain while walking ≥ 40 mm
Who cannot join
- Known allergy to CHONDROITIN SULPHATE, hypersensitivity to CELECOXIB, demonstrated allergic-type reactions to sulphonamides, experienced asthma, urticaria or allergic-type reactions after taking sulphonamides, aspirin (acetyl salicylic acid [ASA]), lactose or NSAIDs
- Active malignancy of any type or history of a malignancy within the last five years other than basal cell carcinoma
- Increased risk for prostate cancer, with prostate cancer, or with a history of prostate cancer within the last five years
- Subjects with other bone and articular diseases (antecedents and/or current signs) such as chondrocalcinosis, Paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis seronegative spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease
- Isolated knee lateral compartment OA defined by joint space loss in the lateral compartment only
- Class IV functional capacity using the American Rheumatism Association criteria
Show all 22Show fewer
- Have had surgery in any lower limb or arthroscopy, aspiration or lavage in any lower limb joint within 180 days of the Baseline Visit
- History of heart attack or stroke, or experienced serious chest pain related to heart disease, or who have had serious diseases of the heart such as congestive heart failure
- High risk of CV events, according to the AHA assessment of CV risk tables
- History of recurrent UGI ulceration or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), a significant coagulation defect, or any other condition, which in the investigator's opinion might preclude the chronic use of CELECOXIB. Subjects may, at the Investigator's discretion, take a PPI or antacids daily as required
- Have been diagnosed as having or have been treated for oesophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication
- Subjects using corticosteroids (oral, injectable; exception of intraarticular/soft tissue injection at the exclusion of the target knee), indomethacin, tramadol, codeine, empracet, therapeutic dose of glucosamine or CHONDROITIN SULPHATE during the 12 weeks preceding inclusion
- Using hyaluronic acid (intra-articular target knee) during the 26 weeks preceding inclusion
- Using Natural Health Products (e.g. capsaicin, boswellia, willow bark), and creams and analgesic gels (e.g. camphor and alcohol based gels) during one week preceding baseline;
- Using Natural Health Products susceptible to increase the risk of bleeding (e.g. garlic, dong quai, etc.) during one week preceding baseline;
- Receiving radioactive synovectomy (target knee) during the 12 weeks preceding inclusion;
- Subjects who are receiving NSAID and do not want to stop during the study
- If treatment of osteoporosis (biphosphonates, SERMS, THS) is necessary, it will have to be continued, unmodified, for the entire duration of the study
- Have used medications with MMP-inhibitory properties (e.g. tetracycline or structurally related compounds) within 28 days prior to the Baseline Visit
- Are taking lithium carbonate, phenytoin or anticoagulants (with the exception of ASA up to a maximum daily dose of 325 mg)
- Have received chondrocyte transplants in any lower extremity joint
- Use oral or topical COXIBs, calcitonin or immunosuppressive drugs
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Institut de Rhumatologie de Montréal
Montreal, Quebec, H2L-1S6
Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM)
Montreal, Quebec, J1H-5N4
Groupe de Recherche en rhumatologie et maladies osseoues
Québec, Quebec, G1V-3M7
Centre de Rhumatologie St. Louis
Sante Foi, Quebec, G1W-4R4
Centre de Recherche musculo-squellettique
Trois-Rivières, Quebec, G8A-1Y2
About this study
Official title: Twenty-four Month Exploratory Study of the Effect of Chondroitin Sulphate on Structural Changes in Knee Osteoarthritis Patients as Assessed by MRI
The main purpose of this study is to compare the cartilage volume loss at the Baseline visit and after 24 months of treatment in patients treated with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily vs. patients treated with CELECOXIB 200 mg daily.
Read the detailed description
To compare long term disease modifiying and symptomatic effects at the Baseline visit and after 24 months of treatment in patients treated with CHONDROITIN SULPHATE 1200 mg daily vs. patients treated with CELECOXIB 200 mg daily.
- Conditions
- Knee Osteoarthritis
- Being tested
- Chondroitin sulfate, Celecoxib
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chondroitin sulfateDrug
Also called Condrosan
Chondroitin sulphate 1200 mg/day, 24 months treatment period
CelecoxibDrug
Celecoxib 200 mg/day, 24 months treatment period
| Study group | Role | What they receive |
|---|---|---|
| Chondroitin sulfate (Condrosan) | Experimental | CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning Receives: Drug: Chondroitin sulfate |
| Celecoxib | Active comparator | CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cartilage Volume Loss of the Lateral Compartment
To compare the cartilage volume loss of the lateral compartment (femoral condyle and tibial plateau) at the Baseline visit and after 12 and 24 months of treatment either with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily or with CELECOXIB 200 mg daily.
Measured: 12 months (Day 364) and 24 months (Day 728)
Secondary outcomes (13)
Cartilage Volume Loss of the Global Knee
To compare the cartilage volume loss of the global knee at the Baseline visit and after 12 and 24 months.
Measured: 12 months (Day 364) and 24 months (Day 728)
Cartilage Volume in the Medial Compartment
To compare the cartilage volume loss of the medial compartment at the Baseline visit and after 12 and 24 months.
Measured: 12 months (Day 364) and 24 months (Day 728)
Synovial Membrane Thickness
To compare the severity of synovitis score (Thickness of the Synovial Membrane in mm) in Global Knee , at the baseline visit and the follow-up visits in subjects treated either with CHONDROITIN SULPHATE (CONDROSAN) or CELECOXIB.
The severity of synovitis was evaluated through four regions of interest (ROIs) in the images of the axial T1-weighted acquisition complemented with the use of the images of the axial T2-weighted acquisition. The thickness of the synovial membrane was evaluated in the global knee and each of the ROIs and results were expressed in millimetres. The four ROIs were the proximal lateral, distal lateral, proximal medial and distal medial.
Measured: Baseline, 12 months (Day 364) and 24 months (Day 728)
Bone Marrow Lesions Score
To compare the bone marrow lesions (BMLs) score in the global knee and the different sub regions at the baseline visit and the follow-up visits in subjects treated either with CHONDROITIN SULPHATE (CONDROSAN) or CELECOXIB.
The BMLs were assessed in the global knee and the different sub region of the knee (medial trochlea, plateau of the medial femoro-tibial joint, femur of the medial femoro-tibial joint, medial posterior condyle, lateral trochlea, plateau of the lateral femoro-tibial joint, femur of the lateral femoro-tibial joint, lateral posterior femur). The BMLs score was defined as a grade (between 0 and 3) in each knee sub region and summed to derive a global knee score ranging between 0 (absent) and 30 (present). Specifically, each grade was scored as follows:
- Grade 0 = Absence of lesion in the sub region
- Grade 1 = less than 25% of the surface
- Grade 2 = 25-50% of the surface
- Grade 3 = more than 50% of the surface
Measured: Baseline, 12 months (Day 364) and 24 months (Day 728)
Synovial Fluid Volume
To compare the synovial fluid volume of the global knee at the Baseline visit and after 24 months.
Measured: Baseline, 12 months (Day 364) and 24 months (Day 728)
Percentage of Participants With the Presence of Extrusion in the Meniscus
The presence of a meniscal extrusion was assessed in each of sub regions. The absence of a severe extrusion in all the sub regions was considered as an absence (score=0) of a severe extrusion in the meniscus. The presence of a severe extrusion in at least one region of the meniscus was sufficient to consider the presence (score=1) of a severe extrusion in the meniscus.
Measured: Baseline, 12 months (Day 364) and 24 months (Day 728)
Visual Analog Scale (VAS)
Visual Analogue Scale: 0 No Pain 10 Maximum Pain Huskisson's VAS measures global pain intensity. Patients were asked to quantify their disease status on a 10 cm VAS as follows: "Please indicate the severity of knee pain experienced during the last 48 hours by marking a (I) through the line". Left hand marker represents "No pain" and right hand marker represents "The worst pain imaginable".
Measured: Baseline, 12 months (Day 364) and 24 months (Day 728)
WOMAC Pain Subscale
Western Ontario \& McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale Score Range: 0 (no pain) - 50 (maximum pain) The study was designed such that the outcome of primary interest is knee pain related to OA. The measure selected to best evaluate this is an improvement in the WOMAC pain subscales. This subscale consists of 5 items which assesses the pain during walking, using stairs, in bed, sitting or lying, and standing.Each item is a 10 cm VAS with 0 and 10 cm representing no pain and extreme pain respectively.
Measured: Baseline, 12 months (Day 364) and 24 months (Day 728)
WOMAC Stiffness Subscale
Western Ontario \& McMaster Universities Osteoarthritis Index, from 0 No Stiffness to 20 Maximum Stiffness WOMAC stiffness subscale was used to measure the stiffness of the knee with pain. Two items are used to assess stiffness grade: after first waking and later in the day.Each item is a 10 cm VAS with 0 and 10 cm representing no difficulty and extreme difficulty respectively.
Measured: Baseline, 12 months (Day 364) and 24 months (Day 728)
WOMAC Function Subscale
Western Ontario \& McMaster Universities Osteoarthritis Index, from 0 No Function to 170 Maximum Function WOMAC functional limitation subscale was used to measure the functionality of the knee with pain. Seventeen items are used to assess functionality of the knee: tair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. Each item is a 10 cm VAS with 0 and 10 cm representing no difficulty and extreme difficulty respectively.
Measured: Baseline, 12 months (Day 364) and 24 months (Day 728)
Short Form (SF-36) Health Survey
The SF-36 is composed of 35 items measuring:
- 8 health concepts (or dimensions), [(Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE) and Mental Health (MH)]
- and 1 reported health transition item.
The 8 health concepts are summarized in 1 physical (PCS) and 1 mental (MCS) component summary measures. PCS is represented by physical function, role limitations-physical, pain, and general health perception. MCS is represented by vitality, social function, role limitations-emotional, and mental health. Subscale items are summed and scaled from 0-100 to give subscale scores; 0= worst health related quality of life (HRQL), 100=best HRQL. PCS and MCS summary scores are constructed as T-scores (mean =50, standard deviation=10) with no minimum or maximum score; higher scores indicate better health status.
Measured: Baseline, 12 months (Day 364) and 24 months (Day 728)
Percentage of Participants With Presence of Joint Swelling and Effusion
Study knees were evaluated at each visit for the presence or absence of swelling and effusion.
Measured: Baseline, 12 months (Day 364) and 24 months (Day 728)
Use of Acetaminophen
Consumption of Acetaminophen: At each post-baseline visit, the investigator had to assess the consumption of acetaminophen, rescue analgesic authorised throughout the study, by reporting the number of caplets dispensed/retrieved since the previous visit.
Daily consumption of acetaminophen was calculated as an average.
Measured: 3 months (Day 91), 6 momnths (Day 182), 12 months (Day 364), 18 monts (Day 546) and 24 months (Day 728)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2014
- Study completionOct 2014
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 (2)Papers the sponsor has linked to this study.
- Other trials for Knee 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioiberica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre Pelletier, MD, Study chair, Principal Author
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354145
- Sponsor's protocol ID
- CS/III-DMOAD-02
- Acronym
- MOSAIC
- Status last verified
- Jul 2016
- First submitted
- 13 May 2011
- Last updated
- 19 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Martel-Pelletier J, Raynauld JP, Mineau F, Abram F, Paiement P, Delorme P, Pelletier JP. Levels of serum biomarkers from a two-year multicentre trial are associated with treatment response on knee osteoarthritis cartilage loss as assessed by magnetic resonance imaging: an exploratory study. Arthritis Res Ther. 2017 Jul 20;19(1):169. doi: 10.1186/s13075-017-1377-y.
PubMed 28728606Pelletier JP, Raynauld JP, Beaulieu AD, Bessette L, Morin F, de Brum-Fernandes AJ, Delorme P, Dorais M, Paiement P, Abram F, Martel-Pelletier J. Chondroitin sulfate efficacy versus celecoxib on knee osteoarthritis structural changes using magnetic resonance imaging: a 2-year multicentre exploratory study. Arthritis Res Ther. 2016 Nov 3;18(1):256. doi: 10.1186/s13075-016-1149-0.
PubMed 27809891
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twenty-four Month Exploratory Study of the Effect of Chondroitin Sulphate on Structural Changes in Knee Osteoarthritis Patients as Assessed by MRI
- ClinicalTrials.gov ID
- NCT01354145
- Acronym / sponsor ID
- MOSAIC / CS/III-DMOAD-02
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- BioibericaIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 16 May 2011 (estimated)
- Results
- Posted 19 Aug 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 purpose of this study is to compare the cartilage volume loss at the Baseline visit and after 24 months of treatment in patients treated with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily vs. patients treated with CELECOXIB 200 mg daily.
Detailed description
To compare long term disease modifiying and symptomatic effects at the Baseline visit and after 24 months of treatment in patients treated with CHONDROITIN SULPHATE 1200 mg daily vs. patients treated with CELECOXIB 200 mg daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chondroitin sulfate (Condrosan) | Experimental | Drug: Chondroitin sulfateCHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning |
| Celecoxib | Active comparator | Drug: CelecoxibCELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals of either sex, aged 40 years and more
- Subjects presenting primary OA of the knee according to ACR criteria with signs of synovitis (warmth, swelling or effusion
- OA of radiological stages 2 and 3 according to Kellgren-Lawrence;
- Minimum joint space width ≥2 mm in the medial femorotibial compartment on standing knee X-ray
- VAS of pain while walking ≥ 40 mm
Key exclusion criteria (22 listed)
- Known allergy to CHONDROITIN SULPHATE, hypersensitivity to CELECOXIB, demonstrated allergic-type reactions to sulphonamides, experienced asthma, urticaria or allergic-type reactions after taking sulphonamides, aspirin (acetyl salicylic acid [ASA]), lactose or NSAIDs
- Active malignancy of any type or history of a malignancy within the last five years other than basal cell carcinoma
- Increased risk for prostate cancer, with prostate cancer, or with a history of prostate cancer within the last five years
- Subjects with other bone and articular diseases (antecedents and/or current signs) such as chondrocalcinosis, Paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis seronegative spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease
- Isolated knee lateral compartment OA defined by joint space loss in the lateral compartment only
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 |
|---|---|---|
| Chondroitin sulfateAlso: CondrosanChondroitin sulphate 1200 mg/day, 24 months treatment period | Drug | Chondroitin sulfate (Condrosan) |
| CelecoxibCelecoxib 200 mg/day, 24 months treatment period | Drug | Celecoxib |
Primary outcome
Cartilage Volume Loss of the Lateral Compartment
Time frame: 12 months (Day 364) and 24 months (Day 728)
To compare the cartilage volume loss of the lateral compartment (femoral condyle and tibial plateau) at the Baseline visit and after 12 and 24 months of treatment either with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily or with CELECOXIB 200 mg daily.
13 secondary outcomes
Cartilage Volume Loss of the Global Knee
Time frame: 12 months (Day 364) and 24 months (Day 728)
Cartilage Volume in the Medial Compartment
Time frame: 12 months (Day 364) and 24 months (Day 728)
Synovial Membrane Thickness
Time frame: Baseline, 12 months (Day 364) and 24 months (Day 728)
Bone Marrow Lesions Score
Time frame: Baseline, 12 months (Day 364) and 24 months (Day 728)
Synovial Fluid Volume
Time frame: Baseline, 12 months (Day 364) and 24 months (Day 728)
Percentage of Participants With the Presence of Extrusion in the Meniscus
Time frame: Baseline, 12 months (Day 364) and 24 months (Day 728)
Visual Analog Scale (VAS)
Time frame: Baseline, 12 months (Day 364) and 24 months (Day 728)
WOMAC Pain Subscale
Time frame: Baseline, 12 months (Day 364) and 24 months (Day 728)
WOMAC Stiffness Subscale
Time frame: Baseline, 12 months (Day 364) and 24 months (Day 728)
WOMAC Function Subscale
Time frame: Baseline, 12 months (Day 364) and 24 months (Day 728)
Short Form (SF-36) Health Survey
Time frame: Baseline, 12 months (Day 364) and 24 months (Day 728)
Percentage of Participants With Presence of Joint Swelling and Effusion
Time frame: Baseline, 12 months (Day 364) and 24 months (Day 728)
Use of Acetaminophen
Time frame: 3 months (Day 91), 6 momnths (Day 182), 12 months (Day 364), 18 monts (Day 546) and 24 months (Day 728)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28728606Martel-Pelletier J, Raynauld JP, Mineau F, Abram F, Paiement P, Delorme P, Pelletier JP. Levels of serum biomarkers from a two-year multicentre trial are associated with treatment response on knee osteoarthritis cartilage loss as assessed by magnetic resonance imaging: an exploratory study. Arthritis Res Ther. 2017 Jul 20;19(1):169. doi: 10.1186/s13075-017-1377-y.
- Derived from this study: PubMed 27809891Pelletier JP, Raynauld JP, Beaulieu AD, Bessette L, Morin F, de Brum-Fernandes AJ, Delorme P, Dorais M, Paiement P, Abram F, Martel-Pelletier J. Chondroitin sulfate efficacy versus celecoxib on knee osteoarthritis structural changes using magnetic resonance imaging: a 2-year multicentre exploratory study. Arthritis Res Ther. 2016 Nov 3;18(1):256. doi: 10.1186/s13075-016-1149-0.
- Individual participant dataSharing planned: No
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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.
Jean-Pierre Pelletier, MD study chair
Principal Author
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chondroitin sulfate and Celecoxib in people with Knee Osteoarthritis, run by Bioiberica at 5 sites in Canada.
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 5 inclusion and 22 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 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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 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?
Yes. Results are posted in the registry (first posted 19 Aug 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?
Cartilage Volume Loss of the Lateral Compartment (time frame: 12 months (Day 364) and 24 months (Day 728)). 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 NCT01354145, which also lists 2 linked publications.
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 19 Aug 2016.