Efficacy of Etoricoxib on Peripheral Hyperalgesia (NCT01088256) | Clinical Trial Compass
TerminatedPhase 2
Efficacy of Etoricoxib on Peripheral Hyperalgesia
Germany9 participantsStarted 2011-02
Plain-language summary
The purpose of the study is to determine the efficacy of etoricoxib on pain patients. The investigators assume that patients with neuropathic pain will have greater pain relief then patients on placebo.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
* …
What they're measuring
1
Superior improvement of peripheral hyperalgesia at day six after initiation of Cox-2-inhibiting-medication in comparison to placebo