Osteoarthritis, KneePhase 1NCT02566564
Intra-articular Lopain (MTX-071) Phase I/IIa Study in Chronic Osteoarthritic Knee Joint Pain
A Phase 1 study testing Lopain in people with Osteoarthritis, Knee, run by Grünenthal GmbH at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Lopain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2016to Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Lopain
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LopainDrug
Also called MTX-071
intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| open label, single arm | Experimental | Open label, single arm, dose escalating Receives: Drug: Lopain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity and severity of AES/SAEs potentially causally related with the study medication
overall and per dose level (descriptive statistics) incidence, intensity and severity of AES/SAEs potentially causally related with the study medication
Measured: up to 6 months
Secondary outcomes (4)
pain relief response: overall and dose response
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
Measured: up to 6 months
duration of pain relief response: overall and dose response
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
Measured: up to 6 months
Acceptance of / satisfaction with treatment as stated by the patients and physicians. (VAS score)
per dose level VAS score on acceptance of / satisfaction with treatment as stated by the patients and physicians.
Measured: up to 6 months
Influence of treatment on functionality of the knee joint and patients' general feeling of health and estimation of daily life conditions (VAS scores)
per dose level VAS scores on functionality of the knee joint and patients' general feeling of health and estimation of daily life conditions
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startApr 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Ramael, Principal investigator, SGS Antwerpen, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566564
- Sponsor's protocol ID
- MTX-071-P01
- Status last verified
- Jul 2021
- First submitted
- 22 Sep 2015
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02566564
- Acronym / sponsor ID
- MTX-071-P01
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label, single arm | Experimental | Drug: LopainOpen label, single arm, dose escalating |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LopainAlso: MTX-071intra-articular injection | Drug | open label, single arm |
Primary outcome
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
4 secondary outcomes
pain relief response: overall and dose response
Time frame: up to 6 months
duration of pain relief response: overall and dose response
Time frame: up to 6 months
Acceptance of / satisfaction with treatment as stated by the patients and physicians. (VAS score)
Time frame: up to 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Ramael principal investigator
SGS Antwerpen, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lopain in people with Osteoarthritis, Knee, run by Grünenthal GmbH at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity and severity of AES/SAEs potentially causally related with the study medication (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.