Efficacy of Parecoxib on Patients With CRPS

NCT ID: NCT01523379

Last Updated: 2012-04-25

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.

Conditions

Causalgia

Interventions

Parecoxib

90mg Parecoxib i.v. two times a day, two days in a row

Intervention Type: DRUG

Placebo

NaCl i.v. two times a day, two days in an row

Intervention Type: DRUG

Other Intervention Names

Dynastat; sodium chlorid

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruhr University of Bochum

OTHER

Sponsor Role: lead

Responsible Party

Christoph Maier

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2009-009433-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

COX2009

Identifier Type: -

Identifier Source: org_study_id