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Osteoarthritis, KneePhase 3MOZArTNCT01887678

Study of Intra-articular Injections vs Placebo in Patients With Pain From Osteoarthritis of the Knee

A Phase 3 study testing Traumeel® / Zeel® Injectable Solution in people with Osteoarthritis, Knee, run by Biologische Heilmittel Heel GmbH at 30 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of this study is to evaluate the effectiveness and safety of a combined Traumeel® / Zeel® injection against placebo (saline) in patients with moderate-to-severe pain associated with osteoarthritis of the knee. Read more about this study

Who is it for?
Ages 45 to 80 years
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Traumeel® / Zeel® Injectable Solution
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
287 participants
Where
30 sitesUnited States
Study dates
Jun 2013to Jan 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Osteoarthritis (OA) of the knee by American College of Rheumatology criteria
  • Men or women between 45-80 years of age.
  • Have documented diagnosis of primary OA of the target knee based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment of the target knee confirmed by standard post-anterior weightbearing X-ray of the knee in full extension taken </= 6 months prior to Visit 1.
  • Currently taking an Nonsteroidal anti-inflammatory drug (NSAID), or acetaminophen on a regular basis (4-7 days/ week) over last 2 weeks prior to Visit 1 and has experienced amelioration of pain on these medications.
  • Must have a 50-foot walk test pain score of less than 40 mm on a 100 mm VAS in the target knee at screening
  • Pain in the non-target (contralateral) knee must not be greater than 30 mm on a 100 mm VAS on 50-foot walk test, and the target knee must be more symptomatic.
Show all 13Show fewer
  • Willingness to stop all OA treatments.
  • Fully informed of the risks of entering the study and willing to provide written consent to enter the study.
  • Able to understand and be willing to comply with all study requirements, particularly the weekly injection regimen for administration of study drug.
  • Primary complaint is pain immediately following an unassisted 50-foot walk. They must show:
  • moderate to severe pain score in the target knee as demonstrated by 40 - 90 mm recorded on a 100 mm VAS, and
  • 20 mm increase in pain from their screening visit pain score (a "flare")
  • pain in the non-target (contralateral) knee must </= 30 mm on a 100 mm VAS

Who cannot join

  • Known hypersensitivity or allergy to any of the components of Traumeel or Zeel
  • Known hypersensitivity or allergy to acetaminophen.
  • Has body mass index (BMI) >38 kg/m2.
  • Avoidance of, or aversion to, nonprescription medications.
  • Clinical symptoms of meniscal instability or significant valgus/ varus that requires corrective osteotomy
  • Any major injury or surgery to the target knee in the prior 12 months.
Show all 41Show fewer
  • One or a combination of the following co-morbidities:
  • other inflammatory arthropathies, gout or pseudogout within previous 6 months
  • avascular necrosis
  • severe bone or joint deformity in target knee
  • osteonecrosis of either knee
  • fibromyalgia
  • pes anserine bursitis
  • lumbar radiculopathy with referred pain to either knee
  • neurogenic or vascular claudication
  • significant anterior knee pain due to diagnosed isolated patella-femoral syndrome in the target knee
  • target knee joint infection or skin disorder/infection to the area surrounding the knee within previous 6 months
  • current treatment or treatment of cancer within the previous 2 years (excluding basal cell or squamous cell carcinoma of the skin)
  • Participated in any experimental drug or device study within the prior one (1) month and/or IA injections six (6) months.
  • Referred pain from other joints
  • Significantly debilitating concurrent infection(s)
  • Significant ligamentous instability
  • Any prior viscosupplementation therapy (in target knee) within 6 months prior to Screening
  • Systemic or IA injection of corticosteroids in any joint within 3 months of enrollment
  • Therapy with oral hyaluronic acid products, and/or oral pharmaceutical products containing glucosamine and/or chondroitin sulphate and/or diacerein
  • Therapy with opioids within the last 90 days including intra-dermal delivery systems (patches)
  • Therapy with autologous stem cells
  • Therapy with coumarins such as warfarin, Coumadin; heparin and derivative substances including low molecular weight heparin, synthetic pentasaccharide inhibitors of factor Xa such as fondaparinux and idraparinux; direct factor Xa inhibitors such as rivaroxaban and apixaban; direct thrombin inhibitors such as hirudin, lepirudin, bivalirudin, argatroban and dabigatran.
  • Concomitant inflammatory or other rheumatologic, neurological or cardiovascular diseases which could affect the evaluation of knee pain
  • Ongoing litigation for workers compensation for musculoskeletal injuries or disorders
  • Use of alcohol of more than 4 drinks per day
  • Clinically important axial deviation (varus, valgus) greater than 15 degrees
  • Concomitant severe OA of the hip or other joints, which might interfere with the assessments required by the study
  • Painful knee conditions other than OA (e.g., Paget's disease)
  • Hemiparesis of lower limbs
  • Significant planned surgery to lower limbs, which might interfere with the patient's ability to comply with study requirements
  • Presence of serious gastrointestinal, renal, hepatic, pulmonary, cardiovascular, neurological disease that might interfere with the outcome of the study or the patient's ability to comply with study requirements
  • Presence of infections and/or skin diseases in the area of the injection site such as psoriasis
  • Females who are pregnant or breast-feeding or not using recognized effective contraceptive measures. Females of childbearing potential (including those less than one year post-menopausal) must agree to maintain reliable birth control throughout the study.
  • Clinically significant abnormal laboratory values.
  • Patients who are likely to be non-compliant or uncooperative during the study.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites

  • Radiant Research Inc. - Akron

    Akron, Ohio, 44311

  • Blair Orthopedic Associates, Inc.

    Altoona, Pennsylvania, 16602

  • Injury Care Medical Center

    Boise, Idaho, 83713

  • PMG Cary Medical Research

    Cary, North Carolina, 27518

  • New Hope Clinical Research

    Charlotte, North Carolina, 28204

  • PMG Research of Charlotte

    Charlotte, North Carolina, 28209

  • Sterling Research Group, Ltd

    Cincinnati, Ohio, 45246

  • Clinical Inquest Center Ltd.

    Dayton, Ohio, 45431

  • Radiant Research Inc. - Denver

    Denver, Colorado, 80239

  • Universal BioPharma Research Inc.

    Dinuba, California, 93618

  • Riverside Clinical Research

    Edgewater, Florida, 32132

  • Global Scientific Innovations

    Evansville, Indiana, 47714

  • Clinical Research Solutions

    Franklin, Tennessee, 37064

  • PMG Research of Knoxville

    Knoxville, Tennessee, 37912

  • PMG Research of Knoxville

    Knoxville, Tennessee, 37938

  • AppleMed Research, Inc.

    Miami, Florida, 33155

  • Manhattan Medical Research

    New York, New York, 10016

  • Research Across America - NY

    New York, New York, 10022

  • Providence Clinical Research

    North Hollywood, California, 91606

  • Hillcrest Clinical Research

    Oklahoma City, Oklahoma, 73119

  • Clinical Research Advantage - Arizona II

    Phoenix, Arizona, 85050

  • Radiant Research Inc.

    Pinellas Park, Florida, 33781

  • PMG Research of Raleigh

    Raleigh, North Carolina, 27609

  • PMG Research of Salisbury

    Salisbury, North Carolina, 28144

  • Radiant Research Inc. - Salt Lake City

    Salt Lake City, Utah, 84123

  • Hans Richard Barthel, M.D., Inc.

    Santa Barbara, California, 93108

  • Clinical Research Solutions

    Smyrna, Tennessee, 37167

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141

  • Tucson Orthopaedic Institute

    Tucson, Arizona, 85712

  • Westlake Medical Research

    Westlake Village, California, 91361

Other trials in United States

About this study

Official title: Multi-center Double-blind Randomized Controlled Trial to Evaluate Effectiveness and Safety of Co-administered Traumeel® / Zeel® Intra-articular Injections vs Placebo in Patients With Moderate-to-Severe Pain With Osteoarthritis of the Knee

The aim of this study is to evaluate the effectiveness and safety of a combined Traumeel® / Zeel® injection against placebo (saline) in patients with moderate-to-severe pain associated with osteoarthritis of the knee.

Read the detailed description

The primary objective is to demonstrate the superiority of Traumeel® and Zeel® co-administered intra-articular (IA) injections vs placebo IA injections on the change in knee pain in patients with moderate to severe knee pain associated with osteoarthritis.

The secondary objectives are to evaluate reduction of pain and stiffness and change in physical function.

Safety is evaluated by the incidence of treatment emergent adverse events during the treatment period and follow up period for all randomized patients.

Being tested
Traumeel® / Zeel® Injectable Solution, Placebo
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Traumeel® / Zeel® Injectable SolutionDrug

    Also called Traumeel, Zeel

    Injection volume is 4.2 mL for active study medication (2.0 mL Zeel plus 2.2 mL Traumeel in one IA injection) on treatment days 1, 8 and 15.

  • PlaceboDrug

    Also called Saline

    Placebo is an injection of Saline

Study groups in NCT01887678
Study groupRoleWhat they receive
Traumeel® / Zeel® Injectable SolutionExperimentalInjection volume is 4.2 mL for active study medication (2.0 mL Zeel plus 2.2 mL Traumeel in one intra articular (IA) injection) on treatment days 1, 8 and 15.
Receives: Drug: Traumeel® / Zeel® Injectable Solution
Placebo injectable solutionPlacebo comparatorInjection volume of placebo is 4.2 mL as well (taken from the 10.0 mL vial by unblinded staff member, rest to be kept for drug accountability)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Knee Pain as Measured by the WOMAC Osteoarthritis (OA) Index Pain Subscale (Section A, Items #1-5) Measured by 100 mm VAS

    Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed 24 parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'. To assess pain, scores from WOMAC Section A, items 1 to 5 are averaged to yield the Pain Subscale total score. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. A two-sided test of equality of the study drug (Traumeel®-Zeel®) and Placebo at level 0.05 was computed using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and the corresponding Baseline value of the primary efficacy variable as a covariate. The test decision was based on the (two-sided) p-value for the corresponding test of no treatment difference.

    Measured: from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)

Secondary outcomes (14)

  1. Pain Subscore (WOMAC Section A, Items #1-5) Measured by 100 mm VAS

    Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed 24 parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'. To assess pain, scores from WOMAC Section A, items 1 to 5 are averaged to yield the Pain Subscale total score. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. Changes in pain subscore were analyzed by using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and Baseline value as a covariate.

    Measured: from Baseline to post-Baseline visits except End of Study Visit (up to day 105)

  2. Stiffness Subscore (WOMAC Section B, Items #6-7) Measured by 100 mm VAS

    Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'. To assess stiffness, scores from WOMAC Section B, items 6 to 7 are averaged to yield the Stiffness Subscale total score. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. Changes in stiffness score were analyzed by using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and Baseline value as a covariate.

    Measured: from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)

  3. Physical Function Bubscore (WOMAC Section C, Items #8-24) Recorded on 100 mm VAS

    Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed 24 parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'. To assess physical function, scores from WOMAC Section C, items 8 to 24 are averaged to yield the Physical Function Subscale total score. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. Changes in Physical Function subscore were analyzed by using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and Baseline value as a covariate.

    Measured: from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)

  4. Total WOMAC Score (All Subscales) Recorded on 100 mm VAS

    Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed 24 parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'. A total WOMAC score was computed by averaging all 24 possible responses. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. Changes in total WOMAC score were analyzed by using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and Baseline value as a covariate.

    Measured: from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)

  5. Patient Global Assessment (PGA)

    Patients made an overall Global Assessment of the knee osteoarthritis with the assessment stages "Very good", "Good", "Fair", "Poor" and "Very poor".

    Measured: from Baseline (Day 1, predose)

  6. Patient Global Assessment (PGA)

    Patients made an overall Global Assessment of the knee osteoarthritis with the assessment stages "Very good", "Good", "Fair", "Poor" and "Very poor".

    Measured: End of Study Visit (up to Day 119)

  7. Physician Global Assessment (PhGA)

    Study Physicians made an overall Global Assessment of the knee osteoarthritis with the assessment stages "Very good", "Good", "Fair", "Poor" and "Very poor".

    Measured: Baseline (Day 1, predose)

  8. Physician Global Assessment (PhGA)

    Study Physicians made an overall Global Assessment of the knee osteoarthritis with the assessment stages "Very good", "Good", "Fair", "Poor" and "Very poor".

    Measured: End of Study Visit (up to Day 119)

  9. Pain Immediately Following the 50-foot Walk (100 mm VAS)

    Changes of the target (treated) knee pain following a 50 feet walk self-assessed by the patients on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'.

    Measured: Baseline (Day 1, predose) to post-Baseline visits (up to day 119)

  10. Time to Walking (50-foot Walk Test)

    Changes in time to walk 50 feet (seconds)

    Measured: Baseline (Day 1, predose) to post-Baseline visits (up to day 119)

  11. Time to 50% Pain Relief (Study Population Measure Statistically Derived)

    Changes of the target (treated) knee pain following a 50 feet walk self-assessed by the patients on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'. The time to 50% pain relief were statistical exercises and were analyzed for each individual patient from their self-assessment.

    Measured: Statistically derived

  12. Patients Achieving 100% Pain Relief

    Changes of the target (treated) knee pain following a 50 feet walk self-assessed by the patients on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'. The time to 100% pain relief were statistical exercises and were analyzed for each individual patient from their self-assessment, however, the prevalence of 100% pain relief did not support an estimate for the median time. The number of patients who reached 100% pain relief is reported and the log rank test for difference in time to 100% pain relief was calculated for each injection.

    Measured: Statistically derived

  13. Time to and Use of Rescue Medication (Acetaminophen up to 3000 mg Per Day for Breakthrough Pain) (Study Population Measure Statistically Derived) - Patients Use

    Time to and use of rescue medication (acetaminophen up to 3000 mg per day for breakthrough pain) as reported by the patients. Patients who used any rescue medication during the study.

    Measured: Statistically derived

  14. Time to and Use of Rescue Medication (Acetaminophen up to 3000 mg Per Day for Breakthrough Pain) (Study Population Measure Statistically Derived). Tablets Taken.

    Time to and use of rescue medication (acetaminophen up to 3000 mg per day for breakthrough pain) (study population measure statistically derived). Total number of tablets taken as reported by patient.

    Measured: Statistically derived

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
287 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01887678
Sponsor's protocol ID
C1301
Acronym
MOZArT
Status last verified
Mar 2018
First submitted
14 Jun 2013
Last updated
2 Apr 2018
Data monitoring committee
No

Publications

  • Lozada CJ, del Rio E, Reitberg DP, Smith RA, Kahn CB, Moskowitz RW. A double-blind, randomized, saline-controlled study of the efficacy and safety of co-administered intra-articular injections of Tr14 and Ze14 for treatment of painful osteoarthritis of the knee: The MOZArT trial. Eur J Integr Med 2017;13:54-63. DOI: 10.1016/j.eujim.2017.07.005;

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Traumeel® / Zeel® Injectable Solution in people with Osteoarthritis, Knee, run by Biologische Heilmittel Heel GmbH at 30 sites in United States.

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 13 inclusion and 41 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 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Knee Pain as Measured by the WOMAC Osteoarthritis (OA) Index Pain Subscale (Section A, Items #1-5) Measured by 100 mm VAS (time frame: from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01887678, which also lists 1 linked publication.

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 2 Apr 2018.

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