Osteoarthritic pain of knee or hip. MedDRA version: 20.0 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859 MedDRA version: 20.0 Level: LLT Classification code 10020108 Term: Hips osteoarthritis System Organ Class: 100000004859
Conditions
Interventions
Product Name: T4P1010
Pharmaceutical Form: Capsule
Sponsors
Tools4Patient
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Men or women of at least 18 years of age. • OA of knee or hip diagnosed since at least 6 months. • 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: a. Knee or hip pain as an average at least half of the time for the last 3 months before screening visit. b. OA of the knee, at least 1 of the following 3 conditions: i. age > 50, ii. morning stiffness 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
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. • Pregnant, breastfeeding, or willing to be pregnant during the study. • Patients with a current or recent history, as determined by the Investigator, a. of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease; b. any known hypersensitivity to corn and/or corn-derived products; which would interfere with the patient's participation in the study. • Any other relevant medical disorder/acute disease state/pain condition like fibromyalgia, lombalgia, generalized OA judged by the Investigator as likely to interfere with the trial or represent a risk for the patient. • 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). • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the relationship between the patient’s profile (as defined by his/her disease history, personality characteristics, expectations, genetic profile and demographic characteristics) and his/her placebo response, as defined by the analgesic effect measured by Average Pain Score (APS) reduction after a placebo treatment on osteoarthritic (OA) pain of knee or hip.;Secondary Objective: • To investigate the placebo effect compare to the control group. • To assess the predictability of placebo response based upon draft algorithm developed in previous study. • To study the relationship between the genetic variation of dopamine, serotonin, opioid and endocannabinoid pathways and the analgesic effect measured by APS reduction after T4P1010 treatment: o Single nucleotide polymorphisms (SNPs) variation of catechol-O- methyltransferase (COMT); monoamine oxidase; dopamine B hydroxylase; dopamine receptor 3 and brain-derived neurotropic factor genes; o SNPs variation of tryptophan hydroxylase-2, 5-Hydroxytryptamine transporter and 5-Hydroxytryptamine receptor 2A; o SNP variation of opioid receptor mu 1 gene; o SNP variation of fatty acid amide hydrolase gene. • To assess the stability of the MPSQ over trial duration.;Primary end point(s): Patient’s change from baseline of pain severity, as measured by the weekly means of the daily APS in the last 24 hours in patients with OA pain of knee or hip during a 12-week treatment therapy period.;Timepoint(s) of evaluation of this end point: APS: from Visit 1 to Visit 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Analgesic outcomes: o The 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; o The 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; o The patient’s change from baseline of condition as measured by the western Ontario and McMaster universities arthritis index (WOMAC); o The patient’s change from baseline of pain severity as measured by the brief pain inventory (BPI); o The patient’s change from baseline of pain severity as measured by the intermittent and constant osteoarthritis pain (ICOAP) questionnaire; o The patient’s change from baseline of patient and Investigator global assessment of changes (PGAC and IGAC). • Personality characteristics outcomes: o To assess the Crombach a of the MPSQ between the end and the start of study.;Timepoint(s) of evaluation of this end point: • Analgesic outcomes: o WPS: daily between Visit 1 and Visit 5; o LPS: daily between Visit 1 and Visit 5; o WOMAC: at each visit; o BPI: at each visit; o ICOAP: at Visit 2, 3, 4 and 5; o PGAC and IGAC: at each visit. • Personality characteristics outcomes: o MPSQ: at Visit 2 and Visit 5. | — |
Countries
Belgium
Contacts
Public ContactClinical Trial Information
Tools4Patient SA
Outcome results
None listed