Clinical trial NCT02566564: Intra-articular Lopain (MTX-071) Phase I/IIa Study in Chronic Osteoarthritic Knee Joint Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis, Knee
Lead sponsor: Grünenthal GmbH
Sponsor class: INDUSTRY
First posted: 2015-10-02
Enrollment: 23
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Intensity and severity of AES/SAEs potentially causally related with the study medication
timeFrame: up to 6 months
Secondary outcomes:
measure: pain relief response: overall and dose response
timeFrame: up to 6 months
measure: duration of pain relief response: overall and dose response
timeFrame: up to 6 months
measure: Acceptance of / satisfaction with treatment as stated by the patients and physicians. (VAS score)
timeFrame: up to 6 months
measure: Influence of treatment on functionality of the knee joint and patients' general feeling of health and estimation of daily life conditions (VAS scores)
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: SGS Antwerpen
Study officials:
affiliation: SGS Antwerpen, Belgium
name: Steven Ramael
role: PRINCIPAL_INVESTIGATOR
References: