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

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ClinicalTrials.gov Identifier: NCT02566564
Recruitment Status : Completed
First Posted : October 2, 2015
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Mestex AG

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Lopain Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : April 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: open label, single arm
Open label, single arm, dose escalating
Drug: Lopain
intra-articular injection
Other Name: MTX-071




Primary Outcome Measures :
  1. Intensity and severity of AES/SAEs potentially causally related with the study medication [ Time Frame: up to 6 months ]
    overall and per dose level (descriptive statistics) incidence, intensity and severity of AES/SAEs potentially causally related with the study medication


Secondary Outcome Measures :
  1. pain relief response: overall and dose response [ Time Frame: up to 6 months ]
    overall and per dose level percentage of patients overall percentage of patients with pain relief response to single intraarticular administration of Lopain (MTX-071) defined as more than a 20% decrease from baseline in mm on the VAS for pain on motion without increase in pain medication

  2. duration of pain relief response: overall and dose response [ Time Frame: up to 6 months ]
    overall and per dose level intra-patients maintenance at 7 days, 1, 3 and 6 months of the pain relief response defined as more than a 20% decrease from baseline in mm on the VAS for pain on motion without increase in pain medication

  3. Acceptance of / satisfaction with treatment as stated by the patients and physicians. (VAS score) [ Time Frame: up to 6 months ]
    per dose level VAS score on acceptance of / satisfaction with treatment as stated by the patients and physicians.

  4. Influence of treatment on functionality of the knee joint and patients' general feeling of health and estimation of daily life conditions (VAS scores) [ Time Frame: up to 6 months ]
    per dose level VAS scores on functionality of the knee joint and patients' general feeling of health and estimation of daily life conditions



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02566564


Locations
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Belgium
SGS Antwerpen
Antwerpen, Belgium
Sponsors and Collaborators
Mestex AG
Investigators
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Principal Investigator: Steven Ramael SGS Antwerpen, Belgium

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Responsible Party: Mestex AG
ClinicalTrials.gov Identifier: NCT02566564     History of Changes
Other Study ID Numbers: MTX-071-P01
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthralgia
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Signs and Symptoms