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

NCT02967302 | Unknown Phase 2 DMC

• 1 other identifier: NEUROIMPA2015
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Knee Arthritis

Keywords

knee arthritis, morphine, local injection, pain

Outcome Measures

Primary Outcomes (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

  1 week

Secondary Outcomes (8)

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

  1 week

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

  2 weeks

• daily activities at baseline, week 1 and 2

  2 weeks

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

  2 weeks

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

  2 weeks

Study Arms (3)

Morphine Sulfate

EXPERIMENTAL

Morphine 3 mg intraarticular once at baseline

Drug: Morphine Sulfate

Triamcinolone

ACTIVE COMPARATOR

Triamcinolone 40 mg intraarticular once at baseline

Drug: Triamcinolone

Placebo

PLACEBO COMPARATOR

NaCl 0,9% 5 ml intraarticular at baseline

Drug: placebo

Interventions

Morphine Sulfate DRUG

active intervention

Also known as: Morphin Hexal

Morphine Sulfate

Triamcinolone DRUG

active control

Also known as: Triamcinolon Liechtenstein

Triamcinolone

placebo DRUG

placebo control

Also known as: NaCl 0.9%

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Hildrun Haibel: lead
• DLR German Aerospace Center: collaborator

Study Sites (1)

Charité CBF Rheumatology

Berlin, 12203, Germany

Location

MeSH Terms

Conditions

Pain

Interventions

Morphine; Triamcinolone; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Hildrun Haibel, PD Dr

  Charité CBF, Rheumatology, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Priv. Doz. Dr. med. Hildrun Haibel

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: November 18, 2016
• Study Start: August 1, 2015
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)