Unilateral Knee OsteoarthritisPhase 4NCT01806207
Durolane Compared to Saline in Patients With Unilateral Knee Osteoarthritis
A Phase 4 study testing Durolane injection and Saline injection in people with Unilateral Knee Osteoarthritis, run by Galderma R&D at 1 site in United Kingdom.
Trial summary
This was a study that compared Durolane injections to saline injections in the treatment of unilateral osteoarthritis of the knee. The patients were randomly assigned one of the two treatments unaware of which treatment they received. The study was conducted at 13 centers in Germany, the United Kingdom and Sweden. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Unilateral Knee Osteoarthritis
- What is being tested?
- Durolane injection and Saline injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2003to Apr 2004
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis according to ACR (American College of Radiology) criteria for the knee
- WOMAC pain score in the range 7 to 17
- Significant knee pain for the majority of days during the past 3 months
- Patient normally active, not bedridden or confined to a wheelchair and able to walk 50 meters without the help of a walker, crutches or a cane
- Patient has attempted but not responded adequately to non-pharmacological therapy(ies)
- Patient co-operative and able to communicate effectively with the investigators
- Signed informed consent obtained
Who cannot join
- Bilateral knee osteoarthritis
- Osteoarthritis or clinically significant pain from other part of the musculoskeletal system than the study knee
- Kellgren Lawrence radiographic score grade IV for the study knee
- Change in physical therapy/occupational therapy for the knee within the last 3 months
- Treatment with nonsteroidal antiinflammatory drugs (NSAIDs) (including topical agents for the study knee) during the last week (or 5 half-lives of the drug, whichever is longer) prior to baseline visit
- Treatment with non-NSAID topicals such as capsaicin for the knee within the last 3 days
Show all 22Show fewer
- Intra-articular injection with corticosteroids in the study knee within the last 3 months
- Use of systemic steroids (excluding inhalation steroids) within the last 3 months
- Intra-articular injections with hyaluronic acid in the study knee within the last 9 months
- Treatment with glucosamine/chondroitin sulfate within the last 3 months
- Treatment with pain relievers except for paracetamol up to 4g/day
- Treatment with anticoagulant (except for acetylsalicylic acid max. 325 mg/day)
- Arthroscopy or any other surgical procedure in the study knee within the last 12 months
- Planned arthroscopy or any other surgical procedure during the study period
- Any medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion (e.g. severe progressive chronic disease, malignancy, bleeding disorder, fibromyalgia)
- Systemic active inflammatory condition or infection, such as Rheumatoid arthritis, inflammatory arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, gout/acute pseudogout or any other connective tissue disease
- Septic arthritis in the study knee within the last 3 months
- Active skin disease or infection in the area of the injection site
- Significant venous or lymphatic stasis present in the legs
- Pregnant or breast-feeding woman or woman of child-bearing potential not practicing adequate contraception
- Subjects that in the opinion of the investigator are unsuitable for inclusion (e.g. subjects not likely to avoid other therapies, subjects not likely to stay in the study during the whole study period, or subjects likely to be unreliable)
- Concurrent participation in any other clinical study or participation within the preceding 30 days
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Southampton General Hospital
Southhampton, Hampshire, SO16 6YD
About this study
Official title: A Double-blind, Randomized, Multi-centre Study of the Efficacy and Safety of a Single Intra-articular Injection With Durolane Compared to Saline in Patients With Unilateral Knee Osteoarthritis
This was a study that compared Durolane injections to saline injections in the treatment of unilateral osteoarthritis of the knee. The patients were randomly assigned one of the two treatments unaware of which treatment they received. The study was conducted at 13 centers in Germany, the United Kingdom and Sweden. Patients were followed for six weeks after study treatment.
- Conditions
- Unilateral Knee Osteoarthritis
- Being tested
- Durolane injection, Saline injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durolane injectionDevice
Saline injectionOther
| Study group | Role | What they receive |
|---|---|---|
| Durolane injection | Active comparator | Intraarticular injection of 3 ml Durolane. Receives: Device: Durolane injection |
| Saline injection | Placebo comparator | Intraarticular injection of physiological sodium chloride (0.9% NaCl) solution pH 7. Receives: Other: Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of responders at 6 weeks.
Proportion of responders was based on the improvement in WOMAC (Western Ontario and McMasters Universities Osteoarthritis Index) pain score.
Measured: At 6 weeks after treatment
Secondary outcomes (5)
WOMAC pain score
Measured: 2 and 4 weeks after treatment
Safety of intraarticular injections of 3 ml Durolane
Safety was assessed by adverse event soliciting.
Measured: Through 6 weeks after treatment
WOMAC stiffness score
Measured: 2, 4 and 6 weeks after treatment
WOMAC physical function score
Measured: 2, 4 and 6 weeks after treatment
Patient assessed global status
Measured: 2, 4 and 6 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startFeb 2003
- Primary completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unilateral Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nigel Arden, MD, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806207
- Sponsor's protocol ID
- 35GA0301
- Status last verified
- Mar 2013
- First submitted
- 5 Mar 2013
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Arden NK, Akermark C, Andersson M, Todman MG, Altman RD. A randomized saline-controlled trial of NASHA hyaluronic acid for knee osteoarthritis. Curr Med Res Opin. 2014 Feb;30(2):279-86. doi: 10.1185/03007995.2013.855631. Epub 2013 Nov 5.
PubMed 24168077
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Multi-centre Study of the Efficacy and Safety of a Single Intra-articular Injection With Durolane Compared to Saline in Patients With Unilateral Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01806207
- Acronym / sponsor ID
- 35GA0301
- Conditions
- Unilateral Knee Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Apr 2004 (actual)
- First posted
- 7 Mar 2013 (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.
This was a study that compared Durolane injections to saline injections in the treatment of unilateral osteoarthritis of the knee. The patients were randomly assigned one of the two treatments unaware of which treatment they received. The study was conducted at 13 centers in Germany, the United Kingdom and Sweden. Patients were followed for six weeks after study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Durolane injection | Active comparator | Device: Durolane injectionIntraarticular injection of 3 ml Durolane. |
| Saline injection | Placebo comparator | Other: Saline injectionIntraarticular injection of physiological sodium chloride (0.9% NaCl) solution pH 7. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Osteoarthritis according to ACR (American College of Radiology) criteria for the knee
- WOMAC pain score in the range 7 to 17
- Significant knee pain for the majority of days during the past 3 months
- Patient normally active, not bedridden or confined to a wheelchair and able to walk 50 meters without the help of a walker, crutches or a cane
- Patient has attempted but not responded adequately to non-pharmacological therapy(ies)
Key exclusion criteria (22 listed)
- Bilateral knee osteoarthritis
- Osteoarthritis or clinically significant pain from other part of the musculoskeletal system than the study knee
- Kellgren Lawrence radiographic score grade IV for the study knee
- Change in physical therapy/occupational therapy for the knee within the last 3 months
- Treatment with nonsteroidal antiinflammatory drugs (NSAIDs) (including topical agents for the study knee) during the last week (or 5 half-lives of the drug, whichever is longer) prior to baseline visit
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 |
|---|---|---|
| Durolane injection | Device | Durolane injection |
| Saline injection | Other | Saline injection |
Primary outcome
Proportion of responders at 6 weeks.
Time frame: At 6 weeks after treatment
Proportion of responders was based on the improvement in WOMAC (Western Ontario and McMasters Universities Osteoarthritis Index) pain score.
5 secondary outcomes
WOMAC pain score
Time frame: 2 and 4 weeks after treatment
Safety of intraarticular injections of 3 ml Durolane
Time frame: Through 6 weeks after treatment
WOMAC stiffness score
Time frame: 2, 4 and 6 weeks after treatment
WOMAC physical function score
Time frame: 2, 4 and 6 weeks after treatment
Patient assessed global status
Time frame: 2, 4 and 6 weeks after treatment
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 25 Aug 2022.
- Derived from this study: PubMed 24168077Arden NK, Akermark C, Andersson M, Todman MG, Altman RD. A randomized saline-controlled trial of NASHA hyaluronic acid for knee osteoarthritis. Curr Med Res Opin. 2014 Feb;30(2):279-86. doi: 10.1185/03007995.2013.855631. Epub 2013 Nov 5.
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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.
Nigel Arden, MD principal investigator
University Hospital Southampton NHS Foundation Trust
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 Durolane injection and Saline injection in people with Unilateral Knee Osteoarthritis, run by Galderma R&D at 1 site in United Kingdom.
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 7 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 25 Aug 2022. 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 United Kingdom. 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.
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?
Proportion of responders at 6 weeks. (time frame: At 6 weeks after treatment). 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 NCT01806207, 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 25 Aug 2022.