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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
Sponsor:
Collaborator:
International Medical Research - Partner GmbH
Information provided by (Responsible Party):
Pro Bono Bio

Brief 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.

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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
Device: Placebo
applicable gel




Primary Outcome Measures :
  1. WOMAC pain score [ Time Frame: 3 months ]
    Change from baseline to final visit of the average of the WOMAC pain subscale scores


Secondary Outcome Measures :
  1. Patient Global Assessment of Change (PGIC) [ Time Frame: 3 months ]
    PGIC-Score at final visit

  2. WOMAC function score [ Time Frame: 3 months ]
    Change from baseline to final visit of the average of the WOMAC function subscale scores

  3. WOMAC stiffness score [ Time Frame: 3 months ]
    Change from baseline to final visit of the average of the WOMAC stiffness subscale scores


Other Outcome Measures:
  1. Adverse Events (AE) [ Time Frame: 3 months ]
    Frequency of treatment emergent AEs per treatment group



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Signed and dated informed consent prior to any study-mandated procedure
  2. Willing and able to comply with study requirements
  3. Outpatients with an age ≥ 50 (starting from the day after the 50th birthday)
  4. Patient for whom their knee pain is the worst pain in the body and is able to identify the predominantly painful (target) knee
  5. 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
  6. NSAID contraindicated or clinically intolerant
  7. 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
  8. If female and able to conceive, patient has a negative urine pregnancy test at screening

Exclusion Criteria:

  • General exclusion criteria

    1. Planned treatment or treatment with another investigational drug within 30 days prior to randomisation
    2. Patients who are inmates of psychiatric wards, prisons, or other state institutions
    3. Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
    4. Pregnancy or lactation
    5. Any planned or expected hospitalisation within the study period
    6. Patients not able to perform the WOMAC test (physically handicapped or immobile patient, e.g. wheel-chair bound)
    7. 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
    8. Skin lesions or dermatological diseases in the treatment area
    9. Extreme obesity (BMI > 35)
    10. Uncontrolled hypertension
    11. Requiring dialysis
    12. Hepatocellular insufficiency preventing use of paracetamol
    13. Alcohol abuse
    14. Intolerance to paracetamol
    15. Malignancy within the past 2 years
    16. Morbus Meulengracht/Gilbert Syndrome
    17. Neurological or psychiatric disorders compromising pain rating by the patient, such as but not limited to depressive disorders, schizophrenia or epilepsy
    18. Any other pain condition requiring acute or chronic use of pain medication that cannot be discontinued at screening
    19. Inflammatory arthritis including rheumatoid arthritis, psoriatic arthritis, gout, pseudo gout, systemic lupus erythematodes, ankylosing spondylitis, mixed connective tissue disease
    20. Symptomatic hip OA ipsilateral to the target knee
    21. Severe (axial misalignment > 10°), uncorrected genu vara and genu valga
    22. Arthroscopy of the target knee within 6 months prior or during the study

Information from the National Library of Medicine

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


Contacts
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Contact: Matthias Rother, MD +49 89 858360925 m.rother@imr-partner.de
Contact: Ilka Rother, MD +49 89 858360911 i.rother@imr-partner.de

Locations
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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   
Sponsors and Collaborators
Pro Bono Bio
International Medical Research - Partner GmbH
Investigators
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Study Director: Matthias Rother, MD International Medical Research - Partner GmbH
Publications:
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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
Keywords provided by Pro Bono Bio:
Osteoarthritis
Pain
NSAID
Sequessome
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases