NCT01523379

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.

Trial Health

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
Last Updated

April 25, 2012

Status Verified

April 1, 2012

First QC Date

January 31, 2012

Last Update Submit

April 24, 2012

Conditions

Causalgia

Keywords

CausalgiaCRPScomplex regional pain syndromeDynastatParecoxib

Interventions

ParecoxibDRUG

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

Also known as: Dynastat
PlaceboDRUG

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

Also known as: sodium chlorid

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CausalgiaComplex Regional Pain Syndromes

Interventions

parecoxib

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNeuralgia

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 1, 2012

Last Updated

April 25, 2012

Record last verified: 2012-04