Phase I/IIa study to determine the safety and clinical effects of intra-articular injections of MTX-071 (Lopain) in patients with chronic osteoarthritic knee-joint pain.
Open label, single-dose, dose-escalating phase I/IIa study to determine the safety and clinical effects of intra-articular injections of MTX-071 (Lopain) in patients with chronic osteoarthritic knee-joint pain.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
23
intra-articular injection
SGS Antwerpen
Antwerp, Belgium
Intensity and severity of AES/SAEs potentially causally related with the study medication
overall and per dose level (descriptive statistics) incidence, intensity and severity of AES/SAEs potentially causally related with the study medication
Time frame: up to 6 months
pain relief response: overall and dose response
overall and per dose level percentage of patients overall percentage of patients with pain relief response to single intraarticular administration of Lopain (MTX-071) defined as more than a 20% decrease from baseline in mm on the VAS for pain on motion without increase in pain medication
Time frame: up to 6 months
duration of pain relief response: overall and dose response
overall and per dose level intra-patients maintenance at 7 days, 1, 3 and 6 months of the pain relief response defined as more than a 20% decrease from baseline in mm on the VAS for pain on motion without increase in pain medication
Time frame: up to 6 months
Acceptance of / satisfaction with treatment as stated by the patients and physicians. (VAS score)
per dose level VAS score on acceptance of / satisfaction with treatment as stated by the patients and physicians.
Time frame: up to 6 months
Influence of treatment on functionality of the knee joint and patients' general feeling of health and estimation of daily life conditions (VAS scores)
per dose level VAS scores on functionality of the knee joint and patients' general feeling of health and estimation of daily life conditions
Time frame: up to 6 months
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