OsteoarthritisOANITNCT02594176
Study of FLEXISEQ® for Treatment of Osteoarthritis of the Knee in NSAID-compromised Patients
A study testing FLEXISEQ® in people with Osteoarthritis, run by Pro Bono Bio at 1 site in Germany.
Trial summary
Primary Objective To substantiate the efficacy of 2.2 g FLEXISEQ® for the treatment of pain related to osteoarthritis (OA) of the knee in patients contraindicated for or with clinical intolerance to NSAIDs. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- FLEXISEQ®
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to Oct 2016
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent prior to any study-mandated procedure
- Willing and able to comply with study requirements
- Outpatients with an age ≥ 50 (starting from the day after the 50th birthday)
- Patient for whom their knee pain is the worst pain in the body and is able to identify the predominantly painful (target) knee
- Patient has a primary diagnosis of Functional Class I-III OA of the target knee and patient meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee
- NSAID contraindicated or clinically intolerant
- Females able to conceive (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate
- If female and able to conceive, patient has a negative urine pregnancy test at screening
Who cannot join
- General exclusion criteria
- Planned treatment or treatment with another investigational drug within 30 days prior to randomisation
- Patients who are inmates of psychiatric wards, prisons, or other state institutions
- Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
- Pregnancy or lactation
- Any planned or expected hospitalisation within the study period
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- Patients not able to perform the WOMAC test (physically handicapped or immobile patient, e.g. wheel-chair bound)
- Any health condition which, in the investigator's opinion means the patient is likely to be unable to complete the 12 week study Medical history related exclusion criteria
- Skin lesions or dermatological diseases in the treatment area
- Extreme obesity (BMI > 35)
- Uncontrolled hypertension
- Requiring dialysis
- Hepatocellular insufficiency preventing use of paracetamol
- Alcohol abuse
- Intolerance to paracetamol
- Malignancy within the past 2 years
- Morbus Meulengracht/Gilbert Syndrome
- Neurological or psychiatric disorders compromising pain rating by the patient, such as but not limited to depressive disorders, schizophrenia or epilepsy
- Any other pain condition requiring acute or chronic use of pain medication that cannot be discontinued at screening
- Inflammatory arthritis including rheumatoid arthritis, psoriatic arthritis, gout, pseudo gout, systemic lupus erythematodes, ankylosing spondylitis, mixed connective tissue disease
- Symptomatic hip OA ipsilateral to the target knee
- Severe (axial misalignment > 10°), uncorrected genu vara and genu valga
- Arthroscopy of the target knee within 6 months prior or during the study
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
IMR-Site #1-30
Gräfelfing, Bavaria, 82166
Matthias Rother, MD, +49 89 858360925, m.rother@imr-partner.de
Ilka Rother, MD, +49 89 858360911, i.rother@imr-partner.de
About this study
Official title: A Randomised, Double-blind, Placebo Controlled Study of Topical FLEXISEQ® for the Treatment of Osteoarthritis of the Knee in Patients Contraindicated for or With Clinical Intolerance to NSAIDs
Primary Objective To substantiate the efficacy of 2.2 g FLEXISEQ® for the treatment of pain related to osteoarthritis (OA) of the knee in patients contraindicated for or with clinical intolerance to NSAIDs.
Secondary Objectives
- To substantiate the efficacy of 2.2 g FLEXISEQ® for the treatment of stiffness and improvement of joint function in patients contraindicated for or with clinical intolerance to NSAIDs and with OA of the knee.
- To substantiate safety and tolerability of 2.2 g FLEXISEQ® in patients contraindicated for or with clinical intolerance to NSAIDs and with OA of the knee.
Read the detailed description
This post marketing clinical follow-up, randomised, double-blind study comparing the efficacy and tolerability of topical FLEXISEQ® with placebo for the treatment of osteoarthritis of the knee in patients contraindicated for or with clinical intolerance to NSAIDs and with OA of the knee will have a total individual treatment period of 12 weeks.
- Conditions
- Osteoarthritis
- Being tested
- FLEXISEQ®, Placebo
- Keywords
- Osteoarthritis, Pain, NSAID, Sequessome
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLEXISEQ®Device
applicable gel
PlaceboDevice
applicable gel
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | 2.2 g FLEXISEQ® twice daily Receives: Device: FLEXISEQ® |
| Placebo | Placebo comparator | 2.2 g placebo twice daily Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC pain score
Change from baseline to final visit of the average of the WOMAC pain subscale scores
Measured: 3 months
Secondary outcomes (3)
Patient Global Assessment of Change (PGIC)
PGIC-Score at final visit
Measured: 3 months
WOMAC function score
Change from baseline to final visit of the average of the WOMAC function subscale scores
Measured: 3 months
WOMAC stiffness score
Change from baseline to final visit of the average of the WOMAC stiffness subscale scores
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pro Bono Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International Medical Research - Partner GmbH
- Responsible party
- Sponsor
- Investigators
- Matthias Rother, MD, Study director, International Medical Research - Partner GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594176
- Sponsor's protocol ID
- CL-064-IV-01 (IMR-062)
- Acronym
- OANIT
- Status last verified
- Feb 2016
- First submitted
- 20 Oct 2015
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Conaghan PG, Dickson J, Bolten W, Cevc G, Rother M. A multicentre, randomized, placebo- and active-controlled trial comparing the efficacy and safety of topical ketoprofen in Transfersome gel (IDEA-033) with ketoprofen-free vehicle (TDT 064) and oral celecoxib for knee pain associated with osteoarthritis. Rheumatology (Oxford). 2013 Jul;52(7):1303-12. doi: 10.1093/rheumatology/ket133. Epub 2013 Mar 28.
PubMed 23542612Rother M, Conaghan PG. A randomized, double-blind, phase III trial in moderate osteoarthritis knee pain comparing topical ketoprofen gel with ketoprofen-free gel. J Rheumatol. 2013 Oct;40(10):1742-8. doi: 10.3899/jrheum.130192. Epub 2013 Sep 1.
PubMed 23996292Kneer W, Rother M, Mazgareanu S, Seidel EJ; European IDEA-033 study group. A 12-week randomized study of topical therapy with three dosages of ketoprofen in Transfersome(R) gel (IDEA-033) compared with the ketoprofen-free vehicle (TDT 064), in patients with osteoarthritis of the knee. J Pain Res. 2013 Oct 25;6:743-53. doi: 10.2147/JPR.S51054. eCollection 2013.
PubMed 24187510
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo Controlled Study of Topical FLEXISEQ® for the Treatment of Osteoarthritis of the Knee in Patients Contraindicated for or With Clinical Intolerance to NSAIDs
- ClinicalTrials.gov ID
- NCT02594176
- Acronym / sponsor ID
- OANIT / CL-064-IV-01 (IMR-062)
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Pain, NSAID, Sequessome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Pro Bono BioIndustry (pharma, biotech, devices)
- Collaborators
- International Medical Research - Partner GmbH
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 2 Nov 2015 (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.
Primary Objective To substantiate the efficacy of 2.2 g FLEXISEQ® for the treatment of pain related to osteoarthritis (OA) of the knee in patients contraindicated for or with clinical intolerance to NSAIDs.
Secondary Objectives
- To substantiate the efficacy of 2.2 g FLEXISEQ® for the treatment of stiffness and improvement of joint function in patients contraindicated for or with clinical intolerance to NSAIDs and with OA of the knee.
- To substantiate safety and tolerability of 2.2 g FLEXISEQ® in patients contraindicated for or with clinical intolerance to NSAIDs and with OA of the knee.
Detailed description
This post marketing clinical follow-up, randomised, double-blind study comparing the efficacy and tolerability of topical FLEXISEQ® with placebo for the treatment of osteoarthritis of the knee in patients contraindicated for or with clinical intolerance to NSAIDs and with OA of the knee will have a total individual treatment period of 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Device: FLEXISEQ®2.2 g FLEXISEQ® twice daily |
| Placebo | Placebo comparator | Device: Placebo2.2 g placebo twice daily |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed and dated informed consent prior to any study-mandated procedure
- Willing and able to comply with study requirements
- Outpatients with an age ≥ 50 (starting from the day after the 50th birthday)
- Patient for whom their knee pain is the worst pain in the body and is able to identify the predominantly painful (target) knee
- Patient has a primary diagnosis of Functional Class I-III OA of the target knee and patient meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee
Key exclusion criteria (23 listed)
- General exclusion criteria
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 |
|---|---|---|
| FLEXISEQ®applicable gel | Device | Test Product |
| Placeboapplicable gel | Device | Placebo |
Primary outcome
WOMAC pain score
Time frame: 3 months
Change from baseline to final visit of the average of the WOMAC pain subscale scores
3 secondary outcomes
Patient Global Assessment of Change (PGIC)
Time frame: 3 months
WOMAC function score
Time frame: 3 months
WOMAC stiffness score
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Background: PubMed 23542612Conaghan PG, Dickson J, Bolten W, Cevc G, Rother M. A multicentre, randomized, placebo- and active-controlled trial comparing the efficacy and safety of topical ketoprofen in Transfersome gel (IDEA-033) with ketoprofen-free vehicle (TDT 064) and oral celecoxib for knee pain associated with osteoarthritis. Rheumatology (Oxford). 2013 Jul;52(7):1303-12. doi: 10.1093/rheumatology/ket133. Epub 2013 Mar 28.
- Background: PubMed 23996292Rother M, Conaghan PG. A randomized, double-blind, phase III trial in moderate osteoarthritis knee pain comparing topical ketoprofen gel with ketoprofen-free gel. J Rheumatol. 2013 Oct;40(10):1742-8. doi: 10.3899/jrheum.130192. Epub 2013 Sep 1.
- Background: PubMed 24187510Kneer W, Rother M, Mazgareanu S, Seidel EJ; European IDEA-033 study group. A 12-week randomized study of topical therapy with three dosages of ketoprofen in Transfersome(R) gel (IDEA-033) compared with the ketoprofen-free vehicle (TDT 064), in patients with osteoarthritis of the knee. J Pain Res. 2013 Oct 25;6:743-53. doi: 10.2147/JPR.S51054. eCollection 2013.
- Individual participant dataSharing planned: Undecided
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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.
Matthias Rother, MD study director
International Medical Research - Partner GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLEXISEQ® in people with Osteoarthritis, run by Pro Bono Bio at 1 site in Germany.
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 8 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 3 Feb 2016. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias Rother, MD (+49 89 858360925, m.rother@imr-partner.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC pain score (time frame: 3 months). 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 NCT02594176, which also lists 3 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 3 Feb 2016.