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Efficacy of Parecoxib on Patients With CRPS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01523379
Expanded Access Status : No longer available
First Posted : February 1, 2012
Last Update Posted : April 25, 2012
Information provided by (Responsible Party):
Christoph Maier, Ruhr University of Bochum

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
Causalgia Drug: Parecoxib Drug: Placebo

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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)

Intervention Details:
  • Drug: Parecoxib
    90mg Parecoxib i.v. two times a day, two days in a row
    Other Name: Dynastat
  • Drug: Placebo
    NaCl i.v. two times a day, two days in an row
    Other Name: sodium chlorid

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

No Contacts or Locations Provided

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Responsible Party: Christoph Maier, Prof. Dr., Ruhr University of Bochum Identifier: NCT01523379     History of Changes
Other Study ID Numbers: COX2009
2009-009433-14 ( EudraCT Number )
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: April 25, 2012
Last Verified: April 2012

Keywords provided by Christoph Maier, Ruhr University of Bochum:
complex regional pain syndrome

Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents