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

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grünenthal GmbH; Mestex AG

Criteria

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.