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

Osteoarthritis Clinical Trial

— OANIT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02594176
• Other study ID #: CL-064-IV-01 (IMR-062)
• Status: Recruiting
• Phase: N/A
• First received: October 20, 2015
• Last updated: February 2, 2016
• Start date: October 2015
• Est. completion date: October 2016

Study information

• Verified date: February 2016
• Source: Pro Bono Bio
• Contact: Matthias Rother, MD
• Phone: +49 89 858360925
• Email: m.rother[@]imr-partner.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• FLEXISEQ®
applicable gel
• Placebo
applicable gel

Locations

Country	Name	City	State
Germany	IMR-Site #1-30	Gräfelfing	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Pro Bono Bio	International Medical Research - Partner GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

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® 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events (AE)	Frequency of treatment emergent AEs per treatment group	3 months	Yes
Primary	WOMAC pain score	Change from baseline to final visit of the average of the WOMAC pain subscale scores	3 months	No
Secondary	Patient Global Assessment of Change (PGIC)	PGIC-Score at final visit	3 months	No
Secondary	WOMAC function score	Change from baseline to final visit of the average of the WOMAC function subscale scores	3 months	No
Secondary	WOMAC stiffness score	Change from baseline to final visit of the average of the WOMAC stiffness subscale scores	3 months	No