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Efficacy of Parecoxib on Patients With CRPS

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

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT01523379
Enrollment
Unknown
Registered
2012-02-01
Start date
Unknown
Completion date
Unknown
Last updated
2012-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Causalgia

Keywords

Causalgia, CRPS, complex regional pain syndrome, Dynastat, Parecoxib

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.

Interventions

DRUGParecoxib

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

DRUGPlacebo

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

Sponsors

Ruhr University of Bochum
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026