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

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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Behavioral: Positive behaviour; Drug: T4P1010 administration; Genetic: Pharmacogenetic; Other: Questionnaires and diary completion

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • CHU Liège, Médecine de l'appareil locomoteur
• France
  • Gières, France, 38610
    • Eurofins Optimed
  • Paris, France, 75012
    • Hopital Saint Antoine AP-HP Rhumatologie
  • Paris, France, 75014
    • Hopital Cochin AP-HP Evaluation et traitement de la Douleur
• United Kingdom
  • Cannock, United Kingdom, WS11 0BN
    • MAC Clinical Research
  • Liverpool, United Kingdom, L34 1BH
    • MAC Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Men or women of at least 18 years of age.
2. Osteoarthritis (OA) of knee or hip diagnosed since at least 6 months.
3. Affiliated with national welfare.
4. Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
5. Have given written informed consent approved by the relevant Ethics Committee governing the study sites.
6. 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.

7. 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:

   1. Knee or hip pain as an average at least half of the time for the last 3 months before screening visit.
   2. 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.

   Exclusion Criteria:

8. 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.
9. 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).
10. 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.
11. Pregnant, breastfeeding, or willing to be pregnant during the study.
12. 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.
13. Uncontrolled epilepsy.
14. 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).
15. Alcohol dependence or regular use of known drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and phencyclidine).
16. 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.
17. Any close relationship with the Investigators or the Sponsor (i.e. belonging to immediate family or subordination link).
18. Under legal protection, according to the national law.
19. Having completed or withdrawn from this study or any study investigating T4P1001.
20. Patient currently enrolled in a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or in an exclusion period according to the national law.
21. Have planned total knee or hip replacement intervention of the referred joint.
22. 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).
23. 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).
24. Have used viscosupplementation or intra articular injection of hyaluronic acid in the referred joint within 3 months prior to Visit 1 or plan to use during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control group	Genetic: Pharmacogenetic; Blood sample of 10 millilitres maximum; Other: Questionnaires and diary completion; Personality, pain and disease questionnaires completion during the study Diary completion between Visit 1 and Visit 5
Active Comparator: Active group	Behavioral: Positive behaviour; Information about T4P1010 treatment; Drug: T4P1010 administration; Provide treatment to be taken twice a day between Visit 2 and Visit 5 as add-on therapy to patient's regular analgesic treatment; Genetic: Pharmacogenetic; Blood sample of 10 millilitres maximum; Other: Questionnaires and diary completion; Personality, pain and disease questionnaires completion during the study Diary completion between Visit 1 and Visit 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	11-point NRS	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	11-point NRS	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)	Scales	From baseline (Day-28) up to Day 85
Patient's change from baseline of pain severity as measured by the brief pain inventory (BPI)	Scales	From baseline (Day-28) up to Day 85
Patient's change from baseline of Investigator and Patient Global Assessment of Changes (IGAC and PGAC)	11-point NRS	From baseline (Day-28) up to Day 85
Cronbach alpha assessment of MPSQ		Day 1 and Day 85

Collaborators and Investigators

• Sponsor: Tools4Patient
• Investigators: Study Director: Alvaro Pereira, Tools4Patient

Publications and helpful links

Helpful Links

• Clinical Trial Results published on EU Clinical Trials Register

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2017
• Primary Completion (Actual): August 24, 2018
• Study Completion (Actual): August 24, 2018

Study Registration Dates

• First Submitted: May 29, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: T1010-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No