Animal experiments analysing anti-hyperalgesic effects of Coxibs show inconsistent results due to different used dosages and varying different pain models. Theoretical the use of NSAIDs is rational, particularly of Coxibs as a part of the neuropathic pain management. But in the newest topical review, there is no valid information available about the effectiveness of these drugs in human neuropathic pain models or in patients with different underlying mechanism, e.g. with or without hyperalgesia.
Conditions
Interventions
Trade Name: Arcoxia
Pharmaceutical Form: Tablet
INN or Proposed INN: etoricoxibe
CAS Number: 202409-33-4
Other descriptive name: 5-chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Concent
Sponsors
BG university hospital Bergmannsheil GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Included will be patients 18 years or older either genera with - persistent moderate or severe pain (> 4 on NRS (1..10)) at rest (average of three daily assessments using a diary for at least two days) . - neuropathic pain associated with a clinical and neurologically proven peripheral nerve injury, radiculopathy, postherpetic neuralgia or polyneuropathy or CRPS - one of the two following QST phenotypes at the baseline assessment: A. signs of peripheral hyperalgesia (that means, pathological decreased heat pain threshold and/or pathological decreased muscle pain threshold) B. without signs of peripheral hyperalgesia (no pathological decreased heat - and/or muscle pain threshold) Each diagnosis will be confirmed by a pain specialist and a neurologists with clinical and neurographic measuring, including standardized QST 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: Excluded will be patients with central pain, Parkinson’s disease or a history of cerebral vascular insult or nerve injury. Excluded will be also all patients with contradictions for the use of Etoricoxib: 1. Hypersensitivity to the active substance or to any of the excipients. 2. Active peptic ulceration or active gastrointestinal (GI) bleeding. 3. Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetyl-salicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors. 4. Pregnancy and lactation 5. Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score =10). 6. Estimated renal creatinine clearance <30 ml/min. 7. Inflammatory bowel disease. 8. Congestive heart failure (NYHA II-IV). 9. Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled 10. Established ischemic heart disease, peripheral arterial disease, and/or cere-bro-vascular disease. • Intake of one of the following drugs (current or in the last 3 days) o selective-serotonin-reuptake-inhibitor o cetoconazole o rifampicin o phenytoin o carbamazepine o dexamethasone or other systemic corticoids o traditional nonsteroidal antiphlogistics o cyclooxygenase-inhibitors o immunsupressives o TNF-a-inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Superior improvement of peripheral hyperalgesia at day six after initiation of Cox-2-inhibiting-medicationin comparison to placebo.;Secondary Objective: (at day 6-8) - the reduction of the average on-going pain - decrease of the neuropathic symptoms intensity (NPSI score) - patients global impression of change (PGIC) - frequency and cumulative 7 day dosage of rescue medication ;Primary end point(s): Worsening of hyperalgesia on the ill hand measured by QST heat pain treshold. | — |
Countries
Germany
Outcome results
None listed