Wirksamkeit von Etoricoxib bei Patienten mit neuropathischen Schmerzen mit und ohne peripherer Hyperalgesie(Efficacy of etoricoxibe in patients with neuropathic pain with and without peripheral hyperalgesia)

• Conditions: 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.; MedDRA version: 12.1Level: LLTClassification code 10007825Term: Causalgia; MedDRA version: 12.1Level: LLTClassification code 10036105Term: Polyneuropathy; MedDRA version: 12.1Level: LLTClassification code 10036376Term: Post herpetic neuralgia; MedDRA version: 12.1Level: LLTClassification code 10037779Term: Radiculopathy; MedDRA version: 12.1Level: LLTClassification code 10034586Term: Peripheral nerve injury

• Registration Number: EUCTR2009-015496-27-DE
• Lead Sponsor: BG university hospital Bergmannsheil GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 65

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified