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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02594176

Acronym

OANIT

Enrollment

600

Registered

2015-11-02

Start date

2015-10-31

Completion date

2016-10-31

Last updated

2016-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Osteoarthritis, Pain, NSAID, Sequessome

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.

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.

Interventions

DEVICEFLEXISEQ®

applicable gel

DEVICEPlacebo

applicable gel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

Germany

Contacts

Primary ContactMatthias Rother, MD

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

Backup ContactIlka Rother, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026