Study of FLEXISEQ® for Treatment of Osteoarthritis of the Knee in NSAID-compromised Patients (OANIT)
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ClinicalTrials.gov Identifier: NCT02594176 |
Recruitment Status : Unknown
Verified February 2016 by Pro Bono Bio.
Recruitment status was: Recruiting
First Posted : November 1, 2015
Last Update Posted : February 3, 2016
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis | Device: FLEXISEQ® Device: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 600 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | October 2015 |
Estimated Primary Completion Date : | March 2016 |
Estimated Study Completion Date : | October 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Test Product
2.2 g FLEXISEQ® twice daily
|
Device: FLEXISEQ®
applicable gel |
Placebo Comparator: Placebo
2.2 g placebo twice daily
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Device: Placebo
applicable gel |
- WOMAC pain score [ Time Frame: 3 months ]Change from baseline to final visit of the average of the WOMAC pain subscale scores
- Patient Global Assessment of Change (PGIC) [ Time Frame: 3 months ]PGIC-Score at final visit
- WOMAC function score [ Time Frame: 3 months ]Change from baseline to final visit of the average of the WOMAC function subscale scores
- WOMAC stiffness score [ Time Frame: 3 months ]Change from baseline to final visit of the average of the WOMAC stiffness subscale scores
- Adverse Events (AE) [ Time Frame: 3 months ]Frequency of treatment emergent AEs per treatment group

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
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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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594176
Contact: Matthias Rother, MD | +49 89 858360925 | m.rother@imr-partner.de | |
Contact: Ilka Rother, MD | +49 89 858360911 | i.rother@imr-partner.de |
Germany | |
IMR-Site #1-30 | Recruiting |
Gräfelfing, Bavaria, Germany, 82166 | |
Contact: Matthias Rother, MD +49 89 858360925 m.rother@imr-partner.de | |
Contact: Ilka Rother, MD +49 89 858360911 i.rother@imr-partner.de |
Study Director: | Matthias Rother, MD | International Medical Research - Partner GmbH |
Responsible Party: | Pro Bono Bio |
ClinicalTrials.gov Identifier: | NCT02594176 |
Other Study ID Numbers: |
CL-064-IV-01 (IMR-062) |
First Posted: | November 1, 2015 Key Record Dates |
Last Update Posted: | February 3, 2016 |
Last Verified: | February 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Osteoarthritis Pain NSAID Sequessome |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |