Study of FLEXISEQ® for Treatment of Osteoarthritis of the Knee in NSAID-compromised Patients (OANIT)

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: FLEXISEQ®; Device: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Gräfelfing, Bavaria, Germany, 82166
      • Recruiting
      • IMR-Site #1-30
      • Contact: Matthias Rother, MD; Phone Number: +49 89 858360925; Email: m.rother@imr-partner.de
      • Contact: Ilka Rother, MD; Phone Number: +49 89 858360911; Email: i.rother@imr-partner.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WOMAC pain score	Change from baseline to final visit of the average of the WOMAC pain subscale scores	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Assessment of Change (PGIC)	PGIC-Score at final visit	3 months
WOMAC function score	Change from baseline to final visit of the average of the WOMAC function subscale scores	3 months
WOMAC stiffness score	Change from baseline to final visit of the average of the WOMAC stiffness subscale scores	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AE)	Frequency of treatment emergent AEs per treatment group	3 months

Collaborators and Investigators

• Sponsor: Pro Bono Bio
• Collaborators: International Medical Research - Partner GmbH
• Investigators: Study Director: Matthias Rother, MD, International Medical Research - Partner GmbH

Publications and helpful links

General 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.
• Rother 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.
• Kneer 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: October 20, 2015
• First Submitted That Met QC Criteria: October 30, 2015
• First Posted (Estimate): November 1, 2015

Study Record Updates

• Last Update Posted (Estimate): February 3, 2016
• Last Update Submitted That Met QC Criteria: February 2, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Osteoarthritis; Pain; NSAID; Sequessome
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CL-064-IV-01 (IMR-062)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided