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Knee ArthritisPhase 2/3NCT02967302

NEUROIMPA - Intraarticular Application of Opioids in Chronic Arthritis of the Knee Joint

A Phase 2/3 study testing Morphine Sulfate and Triamcinolone in people with Knee Arthritis, run by Hildrun Haibel at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To investigate pain and inflammatory parameters (cytokines, immune cells) in knee joint tissue of chronic arthritis patients following intraarticular (i.a.) injections of morphine, a standard steroid or placebo. The primary hypothesis is that i.a. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Knee Arthritis
What is being tested?
Morphine Sulfate and Triamcinolone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
112 participants
Where
1 siteGermany
Study dates
Aug 2015to Dec 2021
Phase
Phase 2/3
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinically detectable and/or ultrasound-visible knee ef-fusion as part of spondyloarthritis (Assessments in SpondyloArthritis international Society, ASAS criteria), Rheumatoid Arthritis, RA (according to American Col-lege of Rheumatology, ACR criteria), undifferentiated mono- or oligoarthritis, Osteoarthritis of the knee, OA.
  • baseline pain score (on a 100 mm Visual Analogue Scale, VAS) >40 mm;
  • male and female patients, age ≥18 - 80 years,
  • body weight 50 - 90 kg.
  • Able and willing to give a written informed consent and comply with the requirements of the study protocol. Only patients who give written informed consent will be in-cluded in the trial.
  • If female: either not of child-bearing potential (meno-pausal since 1 year or surgically sterile) or is willing and able to practice a reliable method of contraception throughout the study with a pearl index <1. Reliable methods of contraception are: condoms plus other methods: implants, injecatbles, combined oral contracep-tives, intrauterine devices, initiated at least 90 days prior to screening. Further reliable methods are a vasecto-mised partner (at least 1 year prior to enrolment), sexual-ly abstinent, surgically sterilized (including hysterecto-my), postmenopausal defined as at least 1 year of spon-taneous amenorrhea (in questionable cases a blood sample with simultaneous levels of follicle stimulating hormone (FSH) above 40 U/l and estradiol below 30 nl/l is confirmatory).
  • If male: either not of child-bearing potential (surgically sterilized, e.g. vasectomy) or is willing and able to prac-tice a reliable method of contraception with a pearl index <1 (see inclusion criterium 6) throughout the study.

Who cannot join

  • Severe cardiovascular, respiratory, metabolic, neurologi-cal, psychiatric disorders; current bacterial infection es-pecially of the knee
  • abuse of analgesics, benzodiazepines, alcohol; "hard drugs"
  • pregnancy, lactation
  • before biopsy thrombocyte count < 100/nl, Quick <50%
  • intake of anticoagulants, anti-aggregants as monothera-py such as ASS 100 will be allowed
  • participation in an investigational trial during the last 30 days or 5 HLT whichever is longer
Show all 10Show fewer
  • treatment with intraarticular steroids during the past 4 weeks in the selected joint.
  • Patients with a history of a severe psychiatric illness, which might interfere with the patient's ability to under-stand the requirements of the study and assessment.
  • Patients who are institutionalised due to regulatory or juridical order. Patients who are an employee of the in-vestigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.
  • Known hypersensitivity to any component of the study medication to morphine or triamcinolone, ileus, respira-tory depression, severe chronic obstructive airway dis-eases, acute abdomen, coagulopathy and/ or infections of the injection site, instability of the injected joint, psori-atic skin manifestation at the injection site, periarticular calcification, non-vascularized bone necrosis, tendon rupture, Charcot-joint.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité CBF Rheumatology

    Berlin, 12203

Other trials in Germany

About this study

Official title: NEUROIMPA "Intraarticular Application of Opioids in Chronic Arthritis"

To investigate pain and inflammatory parameters (cytokines, immune cells) in knee joint tissue of chronic arthritis patients following intraarticular (i.a.) injections of morphine, a standard steroid or placebo.

The primary hypothesis is that i.a. morphine results in significantly lower pain scores and supplemental analgesic consumption than placebo during the first week after injection, an efficacy comparable to standard i.a. steroid (triamcinolone) medication.

Read the detailed description

3 arm, double blind, placebo controlled, prospective, mo-nocenter study, which will be conducted in the Department of Rheumatology, Charité University Medicine Berlin, Cam-pus Benjamin Franklin in collaboration with several rheu-matology and orthopedic practices in the Berlin area. Ultra-sound guided synovial needle biopsy and interventions will only be performed at CBF.

Eligible patients will be treated with either morphine 3 mg i.a., NaCl 0.9% i.a. or triamcinolone 40 mg i.a. at Baseline. The entire study period will be 2 weeks per patient.

Assessment of the primary outcome parameter will be at week 1. The patients will be monitored closely throughout the entire study period with a total of 4 visits (screening, baseline, week 1, week 2).

Safety data will be collected in the adverse events form, vital parameters, physical examination and laboratory tests dur-ing the whole study.

Conditions
Knee Arthritis
Being tested
Morphine Sulfate, Triamcinolone, placebo
Keywords
knee arthritis, morphine, local injection, pain
Medical subject headings
Pain

What participants receive

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

  • Morphine SulfateDrug

    Also called Morphin Hexal

    active intervention

  • TriamcinoloneDrug

    Also called Triamcinolon Liechtenstein

    active control

  • placeboDrug

    Also called NaCl 0.9%

    placebo control

Study groups in NCT02967302
Study groupRoleWhat they receive
Morphine SulfateExperimentalMorphine 3 mg intraarticular once at baseline
Receives: Drug: Morphine Sulfate
TriamcinoloneActive comparatorTriamcinolone 40 mg intraarticular once at baseline
Receives: Drug: Triamcinolone
PlaceboPlacebo comparatorNaCl 0,9% 5 ml intraarticular at baseline
Receives: Drug: placebo

What is being measured

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

  1. Reduction of pain intensity (on a 100mm VAS) at 8 a.m. on day 7 compared to baseline

    Reduction of pain intensity (on a 100mm VAS) at 8 a.m. on day 7 compared to baseline

    Measured: 1 week

Secondary outcomes (8)

  1. Area under the VAS curve (AUC) of VAS pain during the first week until 8 p.m. on day 7

    Area under the VAS curve (AUC) of VAS pain during the first week until 8 p.m. on day 7

    Measured: 1 week

  2. Pain intensity on McGill pain questionnaire (MPQ) at baseline, week 1 and 2

    Pain intensity on McGill pain questionnaire (MPQ) at baseline, week 1 and 2

    Measured: 2 weeks

  3. daily activities at baseline, week 1 and 2

    daily activities at baseline, week 1 and 2

    Measured: 2 weeks

  4. activity and mobility of the knee joint (Lysholm Gilquist-Score) at baseline, week 1 and 2

    activity and mobility of the knee joint (Lysholm Gilquist-Score) at baseline, week 1 and 2

    Measured: 2 weeks

  5. WOMAC scale (before i.a. injections at baseline, week 1 and 2)

    WOMAC scale (before i.a. injections and at the end of each week)

    Measured: 2 weeks

  6. nflammatory parameters (cellular infiltrate, opioid receptors and peptides, IL-17, TNFα) in synovial biopsies and fluid (before i.a. medication at baseline and week 1),

    nflammatory parameters (cellular infiltrate, opioid receptors and peptides, IL-17, TNFα) in synovial biopsies and fluid (before and 7 days af-ter i.a. medication),

    Measured: 1 weeks

  7. supplementary analgesic consumption continuously in the patients diary, recorded at week 1 and 2

    supplementary analgesic consumption continuously in the patients diary, recorded at week 1 and 2

    Measured: 2 weeks

  8. Any systemic (e.g. nausea, sedation) and local side effects (infection, tissue injury) will be recorded continuously in the patients diary, recorded at week 1 and week 2.

    Any systemic (e.g. nausea, sedation) and local side effects (infection, tissue injury) will be recorded continuously in the patients diary, recorded at week 1 and 2.

    Measured: Screening, Baseline, week 1, week 2

Timeline

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

  1. First posted18 Nov 2016 (estimated)
  2. Study startAug 2015
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02967302
Sponsor's protocol ID
NEUROIMPA2015
Status last verified
Aug 2021
First submitted
10 Nov 2016
Last updated
3 Aug 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: no plan

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Morphine Sulfate and Triamcinolone in people with Knee Arthritis, run by Hildrun Haibel at 1 site in Germany.

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 10 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: status not confirmed, as of the sponsor's last update on 3 Aug 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 Germany. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Results are not available in the source record.

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?

Reduction of pain intensity (on a 100mm VAS) at 8 a.m. on day 7 compared to baseline (time frame: 1 week). 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 NCT02967302.

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 3 Aug 2021.

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