Clinical trial NCT01088256: Efficacy of Etoricoxib on Peripheral Hyperalgesia
Official title: Efficacy of Etoricoxib in Patients With Neuropathic Pain With and Without Peripheral Hyperalgesia - A Prove of Concept Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Causalgia
Polyneuropathy
Postherpetic Neuralgia
Peripheral Nerve Injury
Radiculopathy
Keywords: CRPS
Morbus Sudeck
Causalgia
Etoricoxib
Polyneuropathy
post herpetic neuralgia
peripheral nerve injury
radiculopathy
Nervenverletzung
postherpetische Neuralgie
COX-2-Inhibitor
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2010-03-17
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Superior improvement of peripheral hyperalgesia at day six after initiation of Cox-2-inhibiting-medication in comparison to placebo
timeFrame: 12 month
Secondary outcomes:
measure: Reduction of the average on-going pain
timeFrame: 12 month
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Bergmannsheil department of pain therapy
state: Nordrhein-Westfalen
Study officials:
affiliation: University hospital Bergmannsheil department of pain therapy
name: Christoph Maier, Dr.med
role: STUDY_DIRECTOR
References: