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Efficacy of Etoricoxib on Peripheral Hyperalgesia

NCT ID: NCT01088256

Last Updated: 2012-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Causalgia Polyneuropathy Postherpetic Neuralgia Peripheral Nerve Injury Radiculopathy

Keywords

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CRPS Morbus Sudeck Causalgia Etoricoxib Polyneuropathy post herpetic neuralgia peripheral nerve injury radiculopathy Nervenverletzung postherpetische Neuralgie COX-2-Inhibitor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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etoricoxib, peripheral hyperalgesia

14 patient with neuropathic pain and peripheral hyperalgesia get etoricoxib 90mg for 8 days

Group Type ACTIVE_COMPARATOR

Etoricoxib

Intervention Type DRUG

the patients get etoricoxib 90mg for 8 days. They get one pill with 90mg per day

etoricoxib, no peripheral hyperalgesia

14 patients with neuropathic pain without peripheral hyperalgesia get etoricoxib 90mg for 8 days

Group Type ACTIVE_COMPARATOR

Etoricoxib

Intervention Type DRUG

the patients get etoricoxib 90mg for 8 days. They get one pill with 90mg per day

placebo, peripheral hyperalgesia

14 patients with neuropathic pain with peripheral hyperalgesia get placebo for 8 days

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

patients get one pill of placebo (sugar-pill) per day for 8 days.

placebo, no peripheral hyperalgesia

14 patients with neuropathic pain without peripheral hyperalgesia get placebo for 8 days

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

patients get one pill of placebo (sugar-pill) per day for 8 days.

Interventions

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Etoricoxib

the patients get etoricoxib 90mg for 8 days. They get one pill with 90mg per day

Intervention Type DRUG

placebo

patients get one pill of placebo (sugar-pill) per day for 8 days.

Intervention Type DRUG

Other Intervention Names

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Arcoxia

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Christoph Maier, Prof. Dr.

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christoph Maier, Dr.med

Role: STUDY_DIRECTOR

University hospital Bergmannsheil department of pain therapy

Locations

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Bergmannsheil department of pain therapy

Bochum, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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2009-015496-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Etoricox09-10

Identifier Type: -

Identifier Source: org_study_id