Efficacy of Etoricoxib on Peripheral Hyperalgesia
Launched by RUHR UNIVERSITY OF BOCHUM · Mar 16, 2010
Trial Information
Current as of June 28, 2025
Terminated
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients over 18 years 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:
- • signs of peripheral hyperalgesia (that means, pathological decreased heat pain threshold and/or pathological decreased muscle pain threshold)
- • without signs of peripheral hyperalgesia (no pathological decreased heat - and/or muscle pain threshold)
- • Patients of both gender
- • Signed consent form
- • Patients with the ability to understand and follow the instructions of the doctor
- Exclusion Criteria:
- • Excluded will be patients 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:
- • Hypersensitivity to the active substance or to any of the excipients.
- • Active peptic ulceration or active gastrointestinal (GI) bleeding.
- • 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.
- • Pregnancy and lactation
- • Severe hepatic dysfunction (serum albumin \<25 g/l or Child-Pugh score ≥10).
- • Estimated renal creatinine clearance \<30 ml/min.
- • Inflammatory bowel disease.
- • Congestive heart failure (NYHA II-IV).
- • Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled
- • Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
- • Intake of one of the following drugs (current or in the last 3 days)
- • selective-serotonin-reuptake-inhibitor
- • cetoconazole
- • rifampicin
- • phenytoin
- • carbamazepine
- • dexamethasone or other systemic corticoids
- • traditional nonsteroidal antiphlogistics
- • cyclooxygenase-inhibitors
- • immunosuppressives
- • TNF-α-inhibitors
About Ruhr University Of Bochum
Ruhr University Bochum is a prominent research institution located in Germany, renowned for its commitment to advancing medical science and improving healthcare outcomes through innovative clinical research. With a focus on interdisciplinary collaboration, the university actively engages in a range of clinical trials aimed at exploring novel therapeutic approaches and improving patient care. Its dedicated team of researchers and healthcare professionals work together to ensure the highest standards of scientific rigor and ethical conduct, contributing valuable insights to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bochum, Nordrhein Westfalen, Germany
Patients applied
Trial Officials
Christoph Maier, Dr.med
Study Director
University hospital Bergmannsheil department of pain therapy
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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