Patients suffering from pain due to knee osteoarthritis
Conditions
Interventions
Trade Name: Palexia retard 50 mg
Product Name: Palexia Retard
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Tapentadol Hydrochloride
CAS Number: 175591-09-0
Other descriptive name
Sponsors
MRI Research Unit, Radiology Department. Hospital del Mar.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A diagnosis of knee OA and suitable for the study as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. 2. Have a radiological and clinical diagnosis of knee OA based upon American College of Rheumatology (ACR) criteria (1986) affecting at least one knee of a minimum of 3 months in symptom duration prior to screening. 3. Central sensitization as defined by a positive clinical evidence of pain central sensitization affecting the knee combined with a minimum of 2 tender points around the affected knee experimentally verified using pain thresholds (Arendt-Nielsen et al. 2010, Graven-Nielsen et al. 2010, Woolf 2011, Imamura et al. 2008, Nijs et al. 2010). 4. Patients with Brief Pain Inventory (BPI) item 5 score of 6-10 points 5. Subject is either male or female and at least 45 years of age. 6. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. 7. Patients capable to be treated according to the technical specifications of summary of product characteristics (SmPC). 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 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
Exclusion criteria: 1. A female subject is eligible to participate if she is of non-childbearing potential. 2. Body weight >120kg. 3. Severe or non-stable medical conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study aimed at demonstrating, by means of functional MRI (fMRI), the effect of Tapentadol on brain response to knee painful stimulation in knee osteoarthritis patients with clinical evidence of central sensitization.;Secondary Objective: • To investigate Tapentadol effects on functional connectivity during brain resting-state in centrally sensitized patients. This is a methodologically new exploratory approach under development in the MRI Research Unit of Hospital del Mar in Barcelona. The team has achieved relevant recent results (Pujol et al 2014a,b,c, 2015, 2016; Lopez-Sola et al. 2104, Contreras-Rodríguez et al. 2014, Blanco-Hinojo 2016). • To assess the relationships between Tapentadol effects on brain response to painful stimulation and Tapentadol effects on clinical parameters.;Primary end point(s): Brain response to knee painful stimulation (endpoint) will be obtained by applying direct pulsed pressure stimulation on the painful knee and pulsed pressure stimulation on a non-arthritic hyperalgesic area (i.e., the anterior tibial surface of the leg).;Timepoint(s) of evaluation of this end point: Each patient will participate in a total of 3 treatment conditions: tapentadol, placebo and no treatment, after which an MRI exam will be administered in each case (14-21 days after each treatment condition ends). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pain threshold Temporal summation Brief Pain Inventory (BPI) Hospital Anxiety and Depression (HADS) PainDETECT WOMAC;Timepoint(s) of evaluation of this end point: 14-21 days after each treatment condition ends | — |
Countries
Spain
Contacts
Public ContactJesus Pujol
MRI Research Unit, Radiology Department. Hospital del Mar.
Outcome results
None listed