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

NCT02594176 | Unknown

• 1 other identifier: CL-064-IV-01 (IMR-062)
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Osteoarthritis; Pain; NSAID; Sequessome

Outcome Measures

Primary Outcomes (1)

• WOMAC pain score

  Change from baseline to final visit of the average of the WOMAC pain subscale scores

  3 months

Secondary Outcomes (3)

• Patient Global Assessment of Change (PGIC)

  3 months

• WOMAC function score

  3 months

• WOMAC stiffness score

  3 months

Other Outcomes (1)

• Adverse Events (AE)

  3 months

Study Arms (2)

Test Product

EXPERIMENTAL

2.2 g FLEXISEQ® twice daily

Device: FLEXISEQ®

Placebo

PLACEBO COMPARATOR

2.2 g placebo twice daily

Device: Placebo

Interventions

FLEXISEQ® DEVICE

applicable gel

Test Product

Placebo DEVICE

applicable gel

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Pro Bono Bio: lead
• International Medical Research - Partner GmbH: collaborator

Study Sites (1)

IMR-Site #1-30

Gräfelfing, Bavaria, 82166, Germany

RECRUITING

Related 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.

  PMID: 23542612 BACKGROUND

• 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.

  PMID: 23996292 BACKGROUND

• 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.

  PMID: 24187510 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthias Rother, MD

  International Medical Research - Partner GmbH

  STUDY DIRECTOR

Central Study Contacts

Matthias Rother, MD

CONTACT

+49 89 858360925; m.rother@imr-partner.de

Ilka Rother, MD

CONTACT

+49 89 858360911; i.rother@imr-partner.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: November 2, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 3, 2016

Record last verified: 2016-02

Locations

DE (1)