Efficacy of Etoricoxib on Peripheral Hyperalgesia

Phase 2

Terminated

• Conditions: Causalgia; Polyneuropathy; Postherpetic Neuralgia; Peripheral Nerve Injury; Radiculopathy
• Interventions: Drug: Etoricoxib; Drug: placebo

• Registration Number: NCT01088256
• Lead Sponsor: Ruhr University of Bochum

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.

Study Timeline

• Study First Submitted: 2010-03-16
• Study First Submitted QC: 2010-03-16
• Study First Posted: 2010-03-17
• Study Start: 2011-02
• Status Verified: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2012-08-23
• Last Update Posted: 2012-08-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
etoricoxib, peripheral hyperalgesia	Etoricoxib	14 patient with neuropathic pain and peripheral hyperalgesia get etoricoxib 90mg for 8 days
placebo, peripheral hyperalgesia	placebo	14 patients with neuropathic pain with peripheral hyperalgesia get placebo for 8 days
placebo, no peripheral hyperalgesia	placebo	14 patients with neuropathic pain without peripheral hyperalgesia get placebo for 8 days
etoricoxib, no peripheral hyperalgesia	Etoricoxib	14 patients with neuropathic pain without peripheral hyperalgesia get etoricoxib 90mg for 8 days

Primary Outcome Measures

Name	Time	Method
Superior improvement of peripheral hyperalgesia at day six after initiation of Cox-2-inhibiting-medication in comparison to placebo	12 month

Secondary Outcome Measures

Name	Time	Method
Reduction of the average on-going pain	12 month	reduction of the average on-going pain decrease of the neuropathic symptoms intensity (NPSI score) decrease of the patients global impression of change (PGIC) decrease of the frequency and cumulative 7 day dosage of rescue medication

Trial Locations

Locations (1)

Bergmannsheil department of pain therapy; 🇩🇪 Bochum, Nordrhein-Westfalen, Germany