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Efficacy of Etoricoxib on Peripheral Hyperalgesia | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Efficacy of Etoricoxib on Peripheral Hyperalgesia

Efficacy of Etoricoxib in Patients With Neuropathic Pain With and Without Peripheral Hyperalgesia - A Prove of Concept Trial

NCT01088256•Ruhr University of Bochum

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).
+13 more criteria

Locations (1)

Bergmannsheil department of pain therapy

Bochum, North Rhine-Westphalia, Germany

Key Dates

Start Date

February 1, 2011

Primary Completion Date

August 1, 2012

Completion Date

August 1, 2012

Last Updated

August 24, 2012

Enrollment

ACTUAL participants

Conditions

CausalgiaPolyneuropathyPostherpetic NeuralgiaPeripheral Nerve InjuryRadiculopathy

Interventions

Etoricoxib

DRUG

placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 24, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy of Etoricoxib on Peripheral Hyperalgesia

Inclusion Criteria

Exclusion Criteria

A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP

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