Back to resultsStudy of FLEXISEQ® for Treatment of Osteoarthritis of the Knee in NSAID-compromised Patients (OANIT)
Primary Purpose
Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
FLEXISEQ®
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Pain, NSAID, Sequessome
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
General exclusion criteria
- 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)
- 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
- 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
- Neurological or psychiatric disorders compromising pain rating by the patient, such as but not limited to depressive disorders, schizophrenia or epilepsy
- Any other pain condition requiring acute or chronic use of pain medication that cannot be discontinued at screening
- Inflammatory arthritis including rheumatoid arthritis, psoriatic arthritis, gout, pseudo gout, systemic lupus erythematodes, ankylosing spondylitis, mixed connective tissue disease
- Symptomatic hip OA ipsilateral to the target knee
- Severe (axial misalignment > 10°), uncorrected genu vara and genu valga
- Arthroscopy of the target knee within 6 months prior or during the study
Sites / Locations
- IMR-Site #1-30Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Test Product
Placebo
Arm Description
2.2 g FLEXISEQ® twice daily
2.2 g placebo twice daily
Outcomes
Primary Outcome Measures
WOMAC pain score
Change from baseline to final visit of the average of the WOMAC pain subscale scores
Secondary Outcome Measures
Patient Global Assessment of Change (PGIC)
PGIC-Score at final visit
WOMAC function score
Change from baseline to final visit of the average of the WOMAC function subscale scores
WOMAC stiffness score
Change from baseline to final visit of the average of the WOMAC stiffness subscale scores
Full Information
NCT ID
NCT02594176
First Posted
October 20, 2015
Last Updated
February 2, 2016
Sponsor
Pro Bono Bio
Collaborators
International Medical Research - Partner GmbH
1. Study Identification
Unique Protocol Identification Number
NCT02594176
Brief Title
Study of FLEXISEQ® for Treatment of Osteoarthritis of the Knee in NSAID-compromised Patients
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pro Bono Bio
Collaborators
International Medical Research - Partner GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Pain, NSAID, Sequessome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test Product
Arm Type
Experimental
Arm Description
2.2 g FLEXISEQ® twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2.2 g placebo twice daily
Intervention Type
Device
Intervention Name(s)
FLEXISEQ®
Intervention Description
applicable gel
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
applicable gel
Primary Outcome Measure Information:
Title
WOMAC pain score
Description
Change from baseline to final visit of the average of the WOMAC pain subscale scores
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Patient Global Assessment of Change (PGIC)
Description
PGIC-Score at final visit
Time Frame
3 months
Title
WOMAC function score
Description
Change from baseline to final visit of the average of the WOMAC function subscale scores
Time Frame
3 months
Title
WOMAC stiffness score
Description
Change from baseline to final visit of the average of the WOMAC stiffness subscale scores
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Adverse Events (AE)
Description
Frequency of treatment emergent AEs per treatment group
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
General exclusion criteria
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)
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
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
Neurological or psychiatric disorders compromising pain rating by the patient, such as but not limited to depressive disorders, schizophrenia or epilepsy
Any other pain condition requiring acute or chronic use of pain medication that cannot be discontinued at screening
Inflammatory arthritis including rheumatoid arthritis, psoriatic arthritis, gout, pseudo gout, systemic lupus erythematodes, ankylosing spondylitis, mixed connective tissue disease
Symptomatic hip OA ipsilateral to the target knee
Severe (axial misalignment > 10°), uncorrected genu vara and genu valga
Arthroscopy of the target knee within 6 months prior or during the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthias Rother, MD
Phone
+49 89 858360925
Email
m.rother@imr-partner.de
First Name & Middle Initial & Last Name or Official Title & Degree
Ilka Rother, MD
Phone
+49 89 858360911
Email
i.rother@imr-partner.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Rother, MD
Organizational Affiliation
International Medical Research - Partner GmbH
Official's Role
Study Director
Facility Information:
Facility Name
IMR-Site #1-30
City
Gräfelfing
State/Province
Bavaria
ZIP/Postal Code
82166
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Rother, MD
Phone
+49 89 858360925
Email
m.rother@imr-partner.de
First Name & Middle Initial & Last Name & Degree
Ilka Rother, MD
Phone
+49 89 858360911
Email
i.rother@imr-partner.de
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23542612
Citation
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.
Results Reference
background
PubMed Identifier
23996292
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.
Results Reference
background
PubMed Identifier
24187510
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(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.
Results Reference
background
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Study of FLEXISEQ® for Treatment of Osteoarthritis of the Knee in NSAID-compromised Patients
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