Osteoarthritis PatientPhase 2NCT01288001
Study of Evaluating the Duration of Efficacy of One Intra Articular Injection of Sodium Hyaluronate 2.0% in Patients With Painful Osteoarthritis of the Knee
A Phase 2 study testing Ostenil plus in people with Osteoarthritis Patient, run by TRB Chemedica at 1 site in Thailand.
Trial summary
A pilot, open, randomised, controlled, add-on study evaluating the duration of efficacy of one intra articular injection of sodium hyaluronate 2.0% in patients with painful osteoarthritis of the knee Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteoarthritis Patient
- What is being tested?
- Ostenil plus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2011to Jul 2012
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both genders between 40 and 70 years of age;
- Primary tibiofemoral osteoarthritis of the knee according to American College of Rheumatology criteria;
- Pain ≥ 4 on a 10 point scale for at least two out of five subscores of the WOMAC Section A at baseline;
- Radiologically ascertained grade II or III severity knee osteoarthritis on the Kellgren-Lawrence scale;
- Having given signed informed consent.
Who cannot join
- Secondary knee osteoarthritis, including:
- septic arthritis;
- inflammatory joint disease;
- gout;
- recurrent episodes of pseudogout;
- Paget's disease of bone;
Show all 48Show fewer
- articular fracture;
- ochronosis;
- acromegaly;
- haemochromatosis;
- Wilson's disease;
- primary osteochondromatosis.
- Clinical signs of acute flare (pain, warm, erythema, effusion of signal knee) at baseline;
- Axial deviation > 15 degrees in valgus or varus on a standing X-ray;
- Clinically significant medio-lateral or antero-posterior instability;
- Rapid destructive arthritis, evolving arthritis requiring surgery within the coming year;
- Significant injury to the signal knee within 6 months prior to baseline;
- Complete loss of range of motion;
- Painful knee conditions other than osteoarthritis (e.g., Sudeck's atrophy, intra-articular neoplasm, villonodular synovitis);
- Necrosis of one of the femur condyles;
- History or evidence of gout, chondrocalcinosis;
- Peripheral neuropathy;
- Concomitant rheumatic disease:
- fibromyalgia;
- rheumatoid arthritis;
- collagen diseases;
- psoriatic arthritis and other seronegative spondylarthropathies (e.g., ankylosing spondylitis);
- metabolic and crystal-induced arthropathies;
- other osteopathies.
- Contraindications to intra-articular injection according to investigator's judgement (e.g., local infection at injection site, generalised infection with possible bacteraemia);
- Skin disease in the area of injection;
- Severe coagulopathy, ongoing anticoagulation therapy;
- Accompanying OA of the hip of sufficient severity to interfere with the assessment of the signal knee;
- Disease of spine, hip or other lower extremity joints of sufficient degree to affect assessment of the signal knee;
- Poor general health interfering with compliance or assessment;
- Concomitant disease/ailment other than knee OA requiring the regular use of the patient's normal analgesic medicine;
- Initiation of chronic treatment with antihistaminics, glucocorticoids, antidepressants or tranquilisers, within less than 3 months prior to baseline;
- Use of assistive devices other than a cane (walking stick);
- Surgery of the signal knee other than arthroscopy;
- Arthroscopy of the signal knee within one year prior to baseline;
- Treatment with symptomatic slow acting drug for OA (SYSADOA, i.e., chondroitin sulfate, diacerein, glucosamine, piascledine), unless the patient has been on a stable dose for at least 4 months prior to baseline;
- Intra-articular depocorticosteroid injection into the signal knee within 3 months prior to baseline;
- Intra-articular SH injection into the signal knee within 6 months prior to baseline;
- Ascertained hypersensitivity to any product used in the study (SH, paracetamol, diclofenac, omeprazole) or to similar compounds;
- Pregnant or lactating female;
- Female of childbearing potential without adequate contraceptive methods;
- Participation in a drug clinical trial within 3 months prior screening;
- Patients who, in the judgement of the investigator, will not comply with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Open, Randomised, Controlled, add-on Study Evaluating the Duration of Efficacy of One Intra Articular Injection of Sodium Hyaluronate 2.0% in Patients With Painful Osteoarthritis of the Knee
A pilot, open, randomised, controlled, add-on study evaluating the duration of efficacy of one intra articular injection of sodium hyaluronate 2.0% in patients with painful osteoarthritis of the knee
- Conditions
- Osteoarthritis Patient
- Being tested
- Ostenil plus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ostenil plusDrug
2% Sodium Hyaluronate plus Mannitol injection
| Study group | Role | What they receive |
|---|---|---|
| Ostenil plus | Experimental | Patient will get Ostenil plus injection and standard treatment of Osteoarthritis Receives: Drug: Ostenil plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the duration of efficacy of one intra articular injection of Ostenil® Plus in patients with painful osteoarthritis of the knee.
WOMAC score
Measured: 6 months
Secondary outcomes (1)
to evaluate the effects of the study treatment on pain, joint stiffness, joint function and need for analgesic consumption.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis PatientStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- TRB Chemedica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288001
- Sponsor's protocol ID
- OSTP-THA-10-01
- Status last verified
- Nov 2012
- First submitted
- 31 Jan 2011
- Last updated
- 21 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Open, Randomised, Controlled, add-on Study Evaluating the Duration of Efficacy of One Intra Articular Injection of Sodium Hyaluronate 2.0% in Patients With Painful Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT01288001
- Acronym / sponsor ID
- OSTP-THA-10-01
- Conditions
- Osteoarthritis Patient
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- TRB ChemedicaIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 2 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.
A pilot, open, randomised, controlled, add-on study evaluating the duration of efficacy of one intra articular injection of sodium hyaluronate 2.0% in patients with painful osteoarthritis of the knee
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ostenil plus | Experimental | Drug: Ostenil plusPatient will get Ostenil plus injection and standard treatment of Osteoarthritis |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of both genders between 40 and 70 years of age;
- Primary tibiofemoral osteoarthritis of the knee according to American College of Rheumatology criteria;
- Pain ≥ 4 on a 10 point scale for at least two out of five subscores of the WOMAC Section A at baseline;
- Radiologically ascertained grade II or III severity knee osteoarthritis on the Kellgren-Lawrence scale;
- Having given signed informed consent.
Key exclusion criteria (48 listed)
- Secondary knee osteoarthritis, including:
- Clinical signs of acute flare (pain, warm, erythema, effusion of signal knee) at baseline;
- Axial deviation > 15 degrees in valgus or varus on a standing X-ray;
- Clinically significant medio-lateral or antero-posterior instability;
- Rapid destructive arthritis, evolving arthritis requiring surgery within the coming year;
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 |
|---|---|---|
| Ostenil plus2% Sodium Hyaluronate plus Mannitol injection | Drug | Ostenil plus |
Primary outcome
to evaluate the duration of efficacy of one intra articular injection of Ostenil® Plus in patients with painful osteoarthritis of the knee.
Time frame: 6 months
WOMAC score
1 secondary outcome
to evaluate the effects of the study treatment on pain, joint stiffness, joint function and need for analgesic consumption.
Time frame: 6 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 21 Nov 2012.
Related trials for Osteoarthritis Patient
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
Recruiting
Three Variants of the PENG Block With and Without Perineural Adjuvants in Older Adults
Hip Osteoarthritis
Recruiting
Aquatic Exercise in Patients With Knee Osteoarthritis
Central Sensitization, Knee Osteoarthristis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ostenil plus in people with Osteoarthritis Patient, run by TRB Chemedica 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 5 inclusion and 48 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 21 Nov 2012. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
to evaluate the duration of efficacy of one intra articular injection of Ostenil® Plus in patients with painful osteoarthritis of the knee. (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 21 Nov 2012.