Intra-articular Lopain (MTX-071) Phase I/IIa Study in Chronic Osteoarthritic Knee Joint Pain

Grünenthal

Status and phase

Completed

Phase 1

Conditions

Osteoarthritis, Knee

Treatments

Drug: Lopain

Study type

Interventional

Funder types

Industry

Identifiers

NCT02566564

MTX-071-P01

Details and patient eligibility

About

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.

Full description

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.

Enrollment

23 patients

Sex

All

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

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 study medication administration.
Patients positive for human immunodeficiency virus (HIV) antibody, hepatitis C antibody, or for hepatitis B virus surface antigen (HBsAg), tuberculosis.
Patients who had a corticosteroid injection in the knee to be studied within 3 months prior to baseline or are planned to get a corticosteroid injection within 4 weeks following the injection of MTX-071.
Vaccination within 60 days prior to study medication administration.
Systemic 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 subject's participation in the trial.
Patients who are dependent on the sponsor or investigator.