OsteoarthritisNCT00665574
ActaVisc and ActaVisc Mx Intra-articular Injection for Pain Associated With Osteoarthritis in the Knee
A study testing ActaVisc and ActaVisc Mx Intra-articular Injection in people with Osteoarthritis, run by Carbylan Therapeutics, Inc. at 2 sites in Latvia.
Trial summary
To evaluate the safety and performance of ActaVisc™ intra-articular injection (ActaVisc) and ActaVisc Mx, for management of pain associated with osteoarthritis in the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- ActaVisc and ActaVisc Mx Intra-articular Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 2 sitesLatvia
- Study dates
- Mar 2008to Jun 2009
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis (OA) grade 2 or 3.
- Symptoms in the treatment knee for at least 12 months.
- Fully ambulatory patient.
Who cannot join
- Secondary OA resulting from rheumatoid arthritis, chondrocalcinosis, osteonecrosis, chronic fibromyalgia or other autoimmune disease.
- Generalized symptomatic OA in lower extremity joints other than the knees, inflammatory joint disease, bursitis, OA in the hips, or other condition that may interfere with study assessments.
Trial locations and contacts
2 sites in 1 country.
Latvia2 sites
Daugavpils Pilsetas Centrala Slimnica
Daugavpils
State Hospital of Traumatology and Orthopaedics
Riga
About this study
Official title: A Prospective, Multi-center, Randomized, Double-blind Feasibility Study to Evaluate the Safety and Performance of ActaVisc and ActaVisc Mx Intra-articular Injection for Management of Pain Associated With Osteoarthritis in the Knee.
To evaluate the safety and performance of ActaVisc™ intra-articular injection (ActaVisc) and ActaVisc Mx, for management of pain associated with osteoarthritis in the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics
- Conditions
- Osteoarthritis
- Being tested
- ActaVisc and ActaVisc Mx Intra-articular Injection
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActaVisc and ActaVisc Mx Intra-articular InjectionOther
ActaVisc is a hyaluronan based device intended to alleviate the pain associated with osteoarthritis of the knee with a single injection and ActaVisc Mx is the same material combined with a corticosteroid.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ActaVisc Receives: Other: ActaVisc and ActaVisc Mx Intra-articular Injection |
| 2 | Experimental | ActaVisc Mx Intra-articular Injection Receives: Other: ActaVisc and ActaVisc Mx Intra-articular Injection |
| 3 | Placebo comparator | Saline Receives: Other: ActaVisc and ActaVisc Mx Intra-articular Injection |
| 4 | Active comparator | Corticosteroid Receives: Other: ActaVisc and ActaVisc Mx Intra-articular Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the WOMAC Pain subscale average score for the treatment knee.
Measured: 26 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2009
- Study completionJun 2009
Why it stopped: Business decision
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carbylan Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665574
- Sponsor's protocol ID
- AIM 1.0
- Status last verified
- Jul 2009
- First submitted
- 22 Apr 2008
- Last updated
- 14 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, Double-blind Feasibility Study to Evaluate the Safety and Performance of ActaVisc and ActaVisc Mx Intra-articular Injection for Management of Pain Associated With Osteoarthritis in the Knee.
- ClinicalTrials.gov ID
- NCT00665574
- Acronym / sponsor ID
- AIM 1.0
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Carbylan Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 24 Apr 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.
To evaluate the safety and performance of ActaVisc™ intra-articular injection (ActaVisc) and ActaVisc Mx, for management of pain associated with osteoarthritis in the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: ActaVisc and ActaVisc Mx Intra-articular InjectionActaVisc |
| 2 | Experimental | Other: ActaVisc and ActaVisc Mx Intra-articular InjectionActaVisc Mx Intra-articular Injection |
| 3 | Placebo comparator | Other: ActaVisc and ActaVisc Mx Intra-articular InjectionSaline |
| 4 | Active comparator | Other: ActaVisc and ActaVisc Mx Intra-articular InjectionCorticosteroid |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Osteoarthritis (OA) grade 2 or 3.
- Symptoms in the treatment knee for at least 12 months.
- Fully ambulatory patient.
Key exclusion criteria (2 listed)
- Secondary OA resulting from rheumatoid arthritis, chondrocalcinosis, osteonecrosis, chronic fibromyalgia or other autoimmune disease.
- Generalized symptomatic OA in lower extremity joints other than the knees, inflammatory joint disease, bursitis, OA in the hips, or other condition that may interfere with study assessments.
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 |
|---|---|---|
| ActaVisc and ActaVisc Mx Intra-articular InjectionActaVisc is a hyaluronan based device intended to alleviate the pain associated with osteoarthritis of the knee with a single injection and ActaVisc Mx is the same material combined with a corticosteroid. | Other | 1, 2, 3, 4 |
Primary outcome
Change from Baseline in the WOMAC Pain subscale average score for the treatment knee.
Time frame: 26 weeks post treatment
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActaVisc and ActaVisc Mx Intra-articular Injection in people with Osteoarthritis, run by Carbylan Therapeutics, Inc. at 2 sites in Latvia.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 14 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Latvia. 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.
Are results available for this study?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
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?
Change from Baseline in the WOMAC Pain subscale average score for the treatment knee. (time frame: 26 weeks post treatment). 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 14 Jul 2009.