Intra-articular Lopain (MTX-071) Phase I/IIa Study in Chronic Osteoarthritic Knee Joint Pain (NCT02566564) | Clinical Trial Compass
CompletedPhase 1
Intra-articular Lopain (MTX-071) Phase I/IIa Study in Chronic Osteoarthritic Knee Joint Pain
Belgium23 participantsStarted 2016-04
Plain-language summary
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.
Who can participate
Age range40 Years – 70 Years
SexALL
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Inclusion Criteria:
* Written informed consent
* Written informed consent
* Men or women aged between 40 and 70 years
* At least 40 mm on motion and at least 10 mm at rest on the 100 mm-VAS (Visual Analog Scale) for average arthritic joint pain in the knee to be studied during the last 2 days, with or without pain medication.
* Previously documented radiography showing a Kellgren Lawrence Grade 2 - 4 severity.
* Female patients of childbearing potential or female partners of childbearing potential of male patients must agree to use a reliable contraceptive method for at least one month after the injection of MTX-071.
* Subject is highly likely to comply with the protocol and complete the study.
Exclusion Criteria:
* Knee surgery within 6 months before study start or planned for any time during the next 6 months.
* Any injection into the knee to be studied within the preceding 7 days or trauma to the knee not yet healed.
* History of any clinically significant cardiac, renal, and/or other relevant disease or malignancy.
* History of severe allergic or anaphylactic reactions.
* Pregnancy.
* Major bleeding disorder.
* Clinically significant deviation from the normal laboratory values.
* Clinically significant abnormal ECG
* History of clinically relevant drug/chemical/ substance/alcohol abuse within the past 2 years prior to screening.
* Symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within the past 2 weeks prior to …
What they're measuring
1
Intensity and severity of AES/SAEs potentially causally related with the study medication