Overview

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:
GrĂ¼nenthal 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.