Efficacy of Parecoxib on Patients With CRPS

Sponsor

Ruhr University of Bochum (Other)

Overall Status

No longer available

CT.gov ID

NCT01523379

Collaborator

(none)

Study Details

Study Description

Brief Summary

The complex regional pain syndrom is a weighty disease that often results in a lifelong disability. Mostly this disease appears unilateral after comparatively mundane fractures or operations. In early stages CRPS shows inflammatory processes. These inflammatory components can be seen as edema and vasodilatation. These inflammatory processes lead us to the hypothesis that selective COX-2-inhibitors might help patients with CRPS.

Condition or Disease	Intervention/Treatment	Phase
Causalgia	Drug: Parecoxib Drug: Placebo

Study Design

Study Type:

Expanded Access

Official Title:

Efficiacy of the Selctive COX-2-inhibitor Parecoxibe on the Pathological Low Pressure Pain Threshold (PPT) of Patients With Complex Regional Pain Syndrome (CRPS)

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Patients with saved diagnosis of CRPS of the upper extremity based on the current used criteria for diagnosis plus a positiv 3-phase-sceletal-scintilgraphy, if they show pathological PPT-values in QST on the ipsilateral site (Z-values > 2 in age- and gender-based Z-transformation of the raw values)• age ≥ 18 years• Existence of an age-based normal creatinin-clearance (calculated with a defined formula)

Exclusion Criteria:

Important cardiovascular illness for the purpose of heart failure (NYHA II - IV), coronary heart disease (CHD), peripheral artery occlusive disease (PAOD) or unstable hypertension (values constantly over 140/90 mm Hg)
Florid kidney disease
Cerebral disease
Neurological systemic disorder (exception: beginning polyneuropathy with normal values of the PPT on the opposite side)
Lesion of the median nerve (ipsi- oder contralateral)
Acute bleeding disease
Known ulcer of the stomach or duodenum
Inflammatory bowel disease
Positive anamnesis of a gastrointestinal bleeding in the last 5 years
Important hepatic dysfunction (Child- pugh > 9)
Hypersensitivity to the agent or to sulfonamides
Known allergy to acetylsalicylic acid, nonsteroidal antiinflammatory drugs or other selectiv cyclooxygenase-inhibitors
Pregnancy and lactation period
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
immunsupressives
TNF-α-inhibitors