Validation Study to Investigate the Effect of a New Treatment in Patients With Osteoarthritic Pain

NCT03174145 | Completed

• 1 other identifier: T1010-01
• Study Type: interventional
• Target: 73
• Locations: 3 countries
• Sites: 6

Brief Summary

The purpose of this clinical trial conducted in patients suffering from chronic pain is to study the relationship between individual patients' profile and their analgesic response

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Patient's change from baseline of pain severity, as measured by the weekly means of the daily Average Pain Score (APS) in the last 24 hours during a 12-week treatment therapy period

  11-point Numeric Rating Scale (NRS)

  Time zero equals baseline (Day-28) up to Day 85

Secondary Outcomes (6)

• Patient's change from baseline of pain severity as measured by the weekly means of the worst pain score (WPS) in the last 24 hours

  Time zero equals baseline (Day-28) up to Day 85

• Patient's change from baseline of pain severity as measured by the weekly means of the least pain score (LPS) in the last 24 hours

  Time zero equals baseline (Day-28) up to Day 85

• Patient's change from baseline of condition as measured by the western Ontario and McMaster universities arthritis index (WOMAC)

  From baseline (Day-28) up to Day 85

• Patient's change from baseline of pain severity as measured by the brief pain inventory (BPI)

  From baseline (Day-28) up to Day 85

• Patient's change from baseline of Investigator and Patient Global Assessment of Changes (IGAC and PGAC)

  From baseline (Day-28) up to Day 85

Study Arms (2)

Active group

ACTIVE COMPARATOR

Behavioral: Positive behaviour; Drug: T4P1010 administration; Genetic: Pharmacogenetic; Other: Questionnaires and diary completion

Control group

SHAM COMPARATOR

Genetic: Pharmacogenetic; Other: Questionnaires and diary completion

Interventions

Positive behaviour BEHAVIORAL

Information about T4P1010 treatment

Active group

T4P1010 administration DRUG

Provide treatment to be taken twice a day between Visit 2 and Visit 5 as add-on therapy to patient's regular analgesic treatment

Active group

Pharmacogenetic GENETIC

Blood sample of 10 millilitres maximum

Active group; Control group

Questionnaires and diary completion OTHER

Personality, pain and disease questionnaires completion during the study Diary completion between Visit 1 and Visit 5

Active group; Control group

Eligibility Criteria

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

You may qualify if:

• Men or women of at least 18 years of age.
• Osteoarthritis (OA) of knee or hip diagnosed since at least 6 months.
• Affiliated with national welfare.
• Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
• Have given written informed consent approved by the relevant Ethics Committee governing the study sites.
• Pain scores reported during the baseline period preceding randomization with a mean APS on the last 14 reported values before Visit 2 between 3.6 and 8.4 inclusive and to have completed at least 2/3 of each pain score in their diary between Visit 1 and Visit 2.
• Patient with a unilateral or bilateral OA of the knee or hip diagnosed according to the American College of Rheumatology (ACR) criteria based on clinical and radiographic evidence (Altman et al., 1986) (in case of bilateral OA or OA of both knee and hip, the joint to consider should be the most affected one). The clinical diagnosis of OA will be confirmed by the ACR clinical criteria and medical imaging criteria for classification of OA of the knee or hip based upon the following criteria:
• Knee or hip pain as an average at least half of the time for the last 3 months before screening visit.
• OA of the knee, at least 1 of the following 3 conditions:
• i. age \> 50, ii. morning stiffness \<30 minutes, iii. crepitus on active motion and osteophytes.
• OA of the hip, at least 2 of the following 3 conditions:
• i. erythrocyte sedimentation rate \< 20mm/hour, ii. femoral and/or acetabular osteophytes, iii. joint space narrowing (superior, axial, and/or medial). c. Kellgren and Lawrence grade \> 1 as assessed by a recent medical imaging of the referred joint to confirm the diagnosis. If no imaging available, a new anterior- posterior view will be obtained and reviewed by Investigator or his/her delegate(s) to verify that the patient meets the disease diagnostic criteria.

You may not qualify if:

• Change in the " regular analgesic therapy " or introduction of a " regular analgesic therapy " (if none beforehand) for OA in the last 4 weeks prior to Visit 1 or during the study.
• Invariable pain scores reported between Visit 1 and Visit 2 (systematically the same minimum score reported all along, the same mean score reported all along and the same maximum score reported all along).
• Have initiated (or plan to initiate) a program (or modify an existing program in frequency and/or intensity) of physiotherapy or behavioral therapy such as pain self-management, hypnosis, sophrology, meditation program within 2 weeks prior to Visit 1 or during the study.
• Pregnant, breastfeeding, or willing to be pregnant during the study.
• Patients with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the study.
• Uncontrolled epilepsy.
• Any current primary psychiatric condition, including depression or personality disorders (such as Axe II of Diagnostic and Statistical Manual of Mental Disorders (DSM-V); personality disorders and mental retardation).
• Alcohol dependence or regular use of known drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and phencyclidine).
• Any other relevant medical disorder/acute disease state/pain condition like fibromyalgia, lumbalgia, generalized OA judged by the Investigator as likely to interfere with the trial or represent a risk for the patient.
• Any close relationship with the Investigators or the Sponsor (i.e. belonging to immediate family or subordination link).
• Under legal protection, according to the national law.
• Having completed or withdrawn from this study or any study investigating T4P1001.
• Have planned total knee or hip replacement intervention of the referred joint.
• Reduced mobility due to OA (use of lower extremity assistive devices other than a cane or a knee sleeve such as crutches or walker or a knee brace or a "shoe lift" in relation to OA is not allowed).
• Use or plan to use systemic corticosteroids 4 weeks prior to Visit 1 or during the study; Intra-muscular corticosteroid injections or Intra-articular injection of steroids into the referred knee/hip within 3 months before Visit 1 or during the study; Intra-articular injection of corticosteroids into any other sites than the referred knee/hip within 4 weeks prior to Visit 1 or during the study (corticosteroids in topical use are allowed).

Sponsors & Collaborators

• Tools4Patient: lead

Study Sites (6)

CHU Liège, Médecine de l'appareil locomoteur

Liège, 4000, Belgium

Location

Eurofins Optimed

Gières, 38610, France

Location

Hopital Saint Antoine AP-HP Rhumatologie

Paris, 75012, France

Location

Hopital Cochin AP-HP Evaluation et traitement de la Douleur

Paris, 75014, France

Location

Mac Clinical Research

Cannock, WS11 0BN, United Kingdom

Location

Mac Clinical Research

Liverpool, L34 1BH, United Kingdom

Location

Related Links

• Clinical Trial Results published on EU Clinical Trials Register

MeSH Terms

Conditions

Osteoarthritis

Interventions

Pharmacogenomic Testing; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Alvaro Pereira

  Tools4Patient

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 2, 2017
• Study Start: September 18, 2017
• Primary Completion: August 24, 2018
• Study Completion: August 24, 2018
• Last Updated: December 16, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); FR (3); GB (2)