Efficacy of Parecoxib on Patients With CRPS

Causalgia Clinical Trial

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)

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT01523379
• Other study ID #: COX2009
• Secondary ID: 2009-009433-14
• Status: No longer available
• Phase: N/A
• First received: January 31, 2012
• Last updated: April 24, 2012

Study information

• Verified date: April 2012
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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-a-inhibitors

Study Design

N/A

Related Conditions & MeSH terms

• Causalgia
• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy

Intervention

Drug:
• Parecoxib
90mg Parecoxib i.v. two times a day, two days in a row
• Placebo
NaCl i.v. two times a day, two days in an row

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum