chronic osteoarthritic knee joint pain MedDRA version: 21.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859 MedDRA version: 20.0 Level: LLT Classification code 10003244 Term: Arthritic pains System Organ Class: 100000004859 MedDRA version: 20.0 Level: LLT Classification code 10064238 Term: Gonalgia System Organ Class: 100000004859
Conditions
Interventions
Product Name: Lopain
Product Code: MTX-071
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: resiniferatoxin
CAS Number: 57444-62-9
Current Sponsor code: RTX
Other descr
Sponsors
Grünenthal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •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
Exclusion criteria
Exclusion criteria: •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: after 3 and 6 months after injection;Main Objective: Part 1, 2, 3 The primary exploratory objectives are to compare the pain reduction effects (absolute and relative) at 3 months and 6 months of intraarticular injections of different dose levels of MTX-071 (Lopain) relative to placebo in patients with chronic osteoarthritic knee joint pain Specific to Part 3: Same primary objectives as in Part 1 but in a narrowed patients population having insufficient pain relief and was unsatisfied with optimized Standard of Care (including corticosteroids, hyaluronic acid, NSAIDs, opioids, non-pharmacological treatment).;Secondary Objective: •Pain-relieving effect -To compare the pain-relieving effects (expressed as percentages of patient with = 50 % or = 70 % reduction in VAS score relative to Baseline) at 3months and 6months of intra-articular injections of different dose levels of MTX-071 relative to placebo -To compare the improvements on pain, stiffness, and physical function at 3 months and 6 months of intra-articular injections of different dose levels of MTX-071 relative to placebo •Safety To document the safety of different dose levels of MTX-071 and placebo To compare the pain at injection of different dose levels of MTX-071 relative to placebo Specific Part 3 Documentation of efficacy assessments: patient global impression of change(PGIC) and patient specific functional scale(PSFS) Comparison of the pain-relieving effects after a second injection (MTX- 071 ) to those after the first injection in patients having less than 25% reduction of their baseline VAS score on motion after the 6month time point;Primary end point(s): -Absolute reduction of the Visual Analog Scale (VAS) scores for pain on motion as average of the last two days in the target knee joint between Baseline and at 3 months and 6 months. -Percentage of reduction of the Visual Analog Scale (VAS) scores for pain on motion as average of the last two days in the t | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Pain relieving effect -Percentage of patients with = 50% and = 70% decrease in VAS scores for pain on motion in the target knee joint as average of the last two days between Baseline and at 3 months and 6 months. -Percentage of decrease of the WOMAC scores (pain, stiffness, and physical function) between Baseline and at 3 months and 6 months. Specific to Part 3 - WOMAC score is changed from 5-point Likert scale to NRS 0-10 version. - Percentage of evolution of the patient global impression of change (PGIC) and patient specific functional scale (PSFS) scores. •Safety -Changes in safety parameters between Baseline and at 3 months and 6 months. -Incidence, nature and severity of AES/SAEs potentially causally related with the study medication. -Maximal VAS (current pain) scores relative to Baseline (-0.5h) during the Day 1 assessments period. Specific to Part 3 - Documentation of the injection site pain and wrong injections;Timepoint(s) of evaluation of this end point: after 3 and 6 months of injection | — |
Countries
Croatia, Slovakia
Contacts
Public ContactClinical Trials Information
QPS Austria GmbH
Outcome results
None listed