Intra-articular Lopain (MTX-071) Phase I/IIa Study in Chronic Osteoarthritic Knee Joint Pain
CompletedPhase 1NCT02566564
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- An Open Label, Single Dose, Dose-escalating Phase I/IIa Study to Determine the Safety and Clinical Effects of Intra-articular Injections of Lopain (MTX-071) in Patients With Chronic Osteoarthritic Knee Joint Pain
- Conditions
- Interventions
- Drug: Lopain
- Sponsor
- Grünenthal GmbH
- Start date
- 2016-04
- Primary completion
- 2017-06
- Sex
- All
- Age range
- from 40 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- Belgium
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02566564