Chronic pain patients/ mhealthy volunteers MedDRA version: 12.1 Level: LLT Classification code 10049475 Term: Chronic pain
Conditions
Interventions
Trade Name: Tapentadol
Product Name: Tapentadol
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Trade Name: morphine
Product
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient inclusion criteria. (i) Patients diagnosed with small-fiber neuropathy or according to the guidelines of the IASP or other professional pain societies (eg., Netherlands Society of Anesthesiologists); (ii) a pain score of 5 or higher; (iii) age between 18 and 75 years; (iv) being able to give written informed consent. Volunteer inclusion criteria. Healthy volunteers in the age range 18-75 years of either sex. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient and volunteer exclusion criteria. (i) Unable to give written informed consent; (ii) medical disease such as pulmonary, renal, liver, cardiac, gastro-intestinal, vascular (incl. hypertension) disease; (iii) allergy to study medication; (iv) use of strong opioids; (v) use of benzodiazepines; (vi) history of illicit drug abuse or alcohol abuse; (vii) history of psychosis; (viii) epilepsy; (ix) raised intracranial pressure;(x) pregnancy and/or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effectivess of tepantadol vs morphien vs placebo on endogenous pain modulation;Secondary Objective: -;Primary end point(s): Endogenous modulation of pain. Pain perception is modulated via facilitatory and inhibitory control systems. Inhibitory control is most important to chronic pain patients as there are strong indications that failed inhibition constitutes a predisposition to acquired chronic pain. Various systems involved in inhibitory control have been demonstrated over the years. Two systems seem important: (1) top-down inhibition of afferent noxious information by endogenous analgesia originating in the periaquaductal grey (PAG) and affecting pain perception via descending pathways; (2) bottom-up activation of pain modulatory systems via activation of spino-bulbo-spinal loops originating in the dorsal horn of the spinal cord. The effect that the latter system has on pain perception is called Diffuse Noxious Inhibitory Control (DNIC). The two systems are interconnected and DNIC is considered a bottom-up activation of the pain modulatory mechanism, as part of the descending endogenous analgesia system. DNIC dysfunctions or is less efficacious in various complex chronic pain states, such as irritable bowel syndrome, chronic headache, fibromyalgia and temporomandibular disorder. Offset analgesia (OA) is another expression of the endogenous analgesia system and is evoked by noxious stimulation, in order to reduce (or control) the perception of the noxious event. Offset analgesia becomes apart when an even more painful stimulus occurs briefly during prolonged painful stimulation. Due to activation of the endogenous opioid system the prolonged stimulation is perceived less painful after the intense noxious stimulus than therefore. In a current study (P09.107) we observed that patients with neuropathic pain have a delayed OA or sometimes even absent OA, suggesting a crucial role of pain pathways involved in OA in the development of chro | — |
Countries
Netherlands
Outcome results
None listed