Knee OsteoarthritisPhase 2NCT01265459
Different Volumes of Durolane in Knee OA
A Phase 2 study testing Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml in people with Knee Osteoarthritis, run by Galderma R&D at 3 sites in Sweden.
Trial summary
The purpose of the study is to assess the safety and efficacy profiles of new single-injection volumes of Durolane in patients with knee OA. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 3 sitesSweden
- Study dates
- Jan 2011to Nov 2011
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject (female or male)
- 40-85 years of age
- Unilateral knee pain fulfilling American College of Rheumatology (ACR) criteria for diagnosis of osteoarthritis(OA)
- Radiographic evidence of OA in the study knee
- WOMAC pain score of 7-17 in the study knee
- WOMAC pain score of 2-3 in the study knee (WOMAC Likert 3.1 A1)
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- Subject normally active
- Subject has attempted but not responded adequately to previous non-pharmacological therapy(ies)and to simple analgetics
- Subject cooperative and able to communicate effectively with the investigators
- Body mass index ≤ 35 kg/m2;
- Signed informed consent obtained
Who cannot join
- Knee effusion
- Contralateral knee OA
- Clinically significant joint pain from joints other than the knee
- Previous intra-articular steroid injection into the study knee within the last 6 months
- Previous intra-articular Hyaluronic Acid (HA) injection into the study knee within the last 9 months
- Previous allergic type reaction to a HA product
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- Treatment with analgesics other than paracetamol (acetaminophen) (including topical agents for the knee) within 5 half lives of the drug prior to the baseline visit
- Use of analgesics 48 hours preceding the baseline visit
- Use of systemic glucocorticosteroids (excluding inhaled steroids) within the last 3 months
- Treatment with glucosamine/chondroitin sulfate initiated within the past 3 months
- Change in physical therapy for the knee within the last three months
- Arthroscopy or other surgical procedure in the study knee within the past 12 months
- Serious injuries to the study knee in the past
- Any planned arthroscopy or other surgical procedure during the study period
- Previous history or presence of active septic arthritis
- Active skin disease or infection in the area of the injection site
- Systemic active inflammatory condition or infection
- Bleeding diathesis or use of anticoagulants
- History of drug or alcohol abuse within 6 months
- Any medical condition that in the opinion of the investigator makes the subject unsuitable for inclusion
- Pregnant or breastfeeding woman or woman of childbearing potential not practicing adequate contraception
- Involvement in other clinical trials
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Torsten Adalberth
Malmö, 211 36
Christian Akermark
Stockholm, 111 35
Johan Isacson
Upplands Vasby, 194 89
About this study
Official title: Double-Blind, Randomized Study of Three Different Volumes of Durolane in Subjects With Osteoarthritis of the Knee
The purpose of the study is to assess the safety and efficacy profiles of new single-injection volumes of Durolane in patients with knee OA.
Read the detailed description
To assess the safety and efficacy profiles of different volumes of Durolane in patients with knee OA and compare with the current standard single-injection of the product. The study aims to investigate whether different volumes of Durolane compared to the standard injection volume will improve the benefit/risk profile.
- Conditions
- Knee Osteoarthritis
- Being tested
- Durolane 3 ml, Durolane 4,5 ml, Durolane 6 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.
Durolane 3 ml, Durolane 4,5 ml, Durolane 6 mlDevice
Durolane is an intraarticular hyaluronic acid preparation
| Study group | Role | What they receive |
|---|---|---|
| Durolane 3ml | Experimental | Durolane 3 ml is an Intraarticular hyaluronic acid Receives: Device: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml |
| Durolane 4.5 | Experimental | Durolane 4.5 is an Intraarticular hyaluronic acid Receives: Device: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml |
| Durolane 6 ml | Experimental | Durolane 6 ml is an Intraarticular hyaluronic acid Receives: Device: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pain Over 26 Weeks (Change From Baseline)
The study aims to compare the change of pain for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score that consists of 5 questions.
It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much pain the subject has experienced during the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question.
Measured: 26 weeks after treatment compared to baseline
Secondary outcomes (4)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability From Baseline to 26 Weeks After Treatment.
Safety and tolerability will be assessed at each clinic visit (Baseline, 2, 6, 12, 18 and 26 weeks). Standard questions was used, "Since your last clinical visit have you had any health problems?".
Measured: From baseline to 26 weeks after treatment
WOMAC Stiffness Score (Change From Baseline)
The study aims to compare the change of stiffness for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) stiffness score that consists of 2 questions.
It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much stiffness the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question.
Measured: 26 weeks after treatment compared to baseline
WOMAC Physical Function Score (Change From Baseline)
The study aims to compare the physical function for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) physical function score that consists of 17 questions.
It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to performing daily physical activities the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question.
Measured: 26 weeks after treatment compared to baseline
Subject´s Global Assessment of the Status of the Study Knee (Change From Baseline)
The subject will assess his/her global status how the study knee affects them by using a 11-point numerical rating scale, Subject global assessment scale, from "very poor=0" to "excellent=10".
Measured: 26 weeks after treatment compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionNov 2011
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.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per-Erik Melberg, MD, Principal investigator, Kristinelundskliniken, Kristinelundsgatan 13, 411 37 Göteborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265459
- Sponsor's protocol ID
- 35GA1001
- Status last verified
- Mar 2014
- First submitted
- 17 Dec 2010
- Last updated
- 22 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized Study of Three Different Volumes of Durolane in Subjects With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT01265459
- Acronym / sponsor ID
- 35GA1001
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 23 Dec 2010 (estimated)
- Results
- Posted 20 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the safety and efficacy profiles of new single-injection volumes of Durolane in patients with knee OA.
Detailed description
To assess the safety and efficacy profiles of different volumes of Durolane in patients with knee OA and compare with the current standard single-injection of the product. The study aims to investigate whether different volumes of Durolane compared to the standard injection volume will improve the benefit/risk profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Durolane 3ml | Experimental | Device: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 mlDurolane 3 ml is an Intraarticular hyaluronic acid |
| Durolane 4.5 | Experimental | Device: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 mlDurolane 4.5 is an Intraarticular hyaluronic acid |
| Durolane 6 ml | Experimental | Device: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 mlDurolane 6 ml is an Intraarticular hyaluronic acid |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject (female or male)
- 40-85 years of age
- Unilateral knee pain fulfilling American College of Rheumatology (ACR) criteria for diagnosis of osteoarthritis(OA)
- Radiographic evidence of OA in the study knee
- WOMAC pain score of 7-17 in the study knee
Key exclusion criteria (22 listed)
- Knee effusion
- Contralateral knee OA
- Clinically significant joint pain from joints other than the knee
- Previous intra-articular steroid injection into the study knee within the last 6 months
- Previous intra-articular Hyaluronic Acid (HA) injection into the study knee within the last 9 months
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 3 ml, Durolane 4,5 ml, Durolane 6 mlDurolane is an intraarticular hyaluronic acid preparation | Device | Durolane 3ml, Durolane 4.5, Durolane 6 ml |
Primary outcome
Change of Pain Over 26 Weeks (Change From Baseline)
Time frame: 26 weeks after treatment compared to baseline
The study aims to compare the change of pain for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score that consists of 5 questions. It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much pain the subject has experienced during the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question.
4 secondary outcomes
Number of Participants With Adverse Events as a Measure of Safety and Tolerability From Baseline to 26 Weeks After Treatment.
Time frame: From baseline to 26 weeks after treatment
WOMAC Stiffness Score (Change From Baseline)
Time frame: 26 weeks after treatment compared to baseline
WOMAC Physical Function Score (Change From Baseline)
Time frame: 26 weeks after treatment compared to baseline
Subject´s Global Assessment of the Status of the Study Knee (Change From Baseline)
Time frame: 26 weeks after treatment compared to baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Per-Erik Melberg, MD principal investigator
Kristinelundskliniken, Kristinelundsgatan 13, 411 37 Göteborg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml in people with Knee Osteoarthritis, run by Galderma R&D at 3 sites in Sweden.
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 11 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 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
Yes. Results are posted in the registry (first posted 20 Jan 2014). 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?
Change of Pain Over 26 Weeks (Change From Baseline) (time frame: 26 weeks after treatment compared to baseline). 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 22 Sep 2022.