Clinical Trials/NCT03174145

NCT03174145

Completed

Not Applicable

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

Tools4Patient5 sites in 3 countries73 target enrollmentSeptember 18, 2017

ConditionsOsteoarthritis

InterventionsPositive behaviour T4P1010 administration Pharmacogenetic Questionnaires and diary completion

DrugsT4P1010 administration

Overview

Phase: Not Applicable
Intervention: Positive behaviour
Conditions: Osteoarthritis
Sponsor: Tools4Patient
Enrollment: 73
Locations: 5
Primary Endpoint: 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
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

September 18, 2017

End Date

August 24, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tools4Patient

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•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.

Exclusion Criteria

•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).

Arms & Interventions

Active group

Intervention: Positive behaviour

Active group

Intervention: T4P1010 administration

Active group

Intervention: Pharmacogenetic

Active group

Intervention: Questionnaires and diary completion

Control group

Intervention: Pharmacogenetic

Control group

Intervention: Questionnaires and diary completion

Outcomes

Primary Outcomes

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

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

11-point Numeric Rating Scale (NRS)

Secondary Outcomes

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 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 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)
Cronbach alpha assessment of MPSQ(Day 1 and Day 85)