The pain reduction effects of different doses of Lopain (MTX-071) relative to placebo are evaluated in patients with chronic osteoarthritic knee joint pain.
- Conditions
- chronic osteoarthritic knee joint painMedDRA version: 21.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859MedDRA version: 20.0Level: LLTClassification code 10003244Term: Arthritic painsSystem Organ Class: 100000004859MedDRA version: 20.0Level: LLTClassification code 10064238Term: GonalgiaSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2018-000818-37-HR
- Lead Sponsor
- Mestex AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 156
•Written informed consent
•Otherwise healthy (or with stable medical conditions) men or women
with knee osteoarthritis aged between 40 and 80 years (extremes
included).
•At least 40 mm on motion on the 100 mm-VAS (Visual Analog Scale) for
average osteoarthritic joint pain in the target knee during the last 2
days, with or without pain medication.
• Only for Part 3: Documented history indicating that subject had
insufficient pain relief and was unsatisfied with optimized Standard of
Care, i.e.
a. non-pharmacological treatment, and
b. treatment with oral or topical NSAIDS, and
c. intra-articular treatment with corticosteroids,
d. and where appropriate intra-articular treatment with hyaluronic acid
and/or opioids in combination or as monotherapies,
or subject is unable to take Standard of Care due to contraindication or
intolerability. If this refers only to one of the Standard of Care
treatments the criterion above applies for the other treatment options.
•Previous assessment (e.g. radiography, MRI or arthroscopy, not older
than 3 years) showing a Kellgren Lawrence Grade of 2 – 4.
•Female patients are only eligible for the study if they are either
surgically sterile or at least 2 years postmenopausal.
•Sexually active male patients must agree to use a reliable contraceptive
method for at least one month after the injection of MTX-071/Placebo.
•Patient is highly likely to comply with the protocol and complete the
study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 104
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52
•Previous exposure to the study drug of the target knee.
•Any contra-indication as per summary of product characteristics for the
premedication used.
•Surgery of the target knee within 6 months before study start or
planned surgery for any time during the next 6 months.
•Any injection into the target knee within the previous month or trauma
to the knee not yet healed.
• Only for Part 3: The subject is not able to clearly identify the target
knee (i.e. the more painful knee)
•History of uncontrolled (at the discretion of the investigator)
cardiovascular, renal, and/or other disease or malignancy.
•History of severe allergic or anaphylactic reactions.
•Male patients whose partner is planning to receive a child
•Major bleeding disorder encompassing, but not limited to coagulopathy
and any current antithrombotic and anticoagulant events. Low dose
acetylsalicylic acid for cardiovascular prevention can be allowed in
consultation with the medical monitor.
•Clinically significant (at the discretion of the investigator) deviation
from the normal laboratory values.
•Clinically significant (at the discretion of the investigator) abnormal
ECG.
•History of drug/chemical/substance/alcohol abuse within the past 2
years prior to Screening.
•Significant (at the discretion of the investigator) symptomatic, viral,
bacterial (including upper respiratory infection), or fungal (noncutaneous)
infection within the past 2 weeks prior to study medication administration.
•Patients positive for human immunodeficiency virus (HIV) antibody,
hepatitis C antibody, or for hepatitis B virus surface antigen (HBsAg).
• Patients who had a corticosteroid or hyaluronic acid injection in the
target knee within 3 months prior to Baseline or are planned to get a
corticosteroid injection within 6 months (Part 1, Part 2 and Part 3), any
other such injection within 3 months (Part 1 and Part 2 only) following
the injection of MTX-071/placebo or any other such injection within 6
months (Part 3 only) following the first injection of MTX-071/placebo.
•Systemic (except inhaled) immunosuppressant agent within 6 months
prior to study medication administration.
•Experimental agent within 30 days or ten half-lives, whichever is
longer, prior to study medication administration.
•Any other condition, which in the opinion of the investigator precludes
the patient's participation in the trial.
•Patients who are dependent on the sponsor or investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method