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Efficacy of Parecoxib on Patients With CRPS

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Christoph Maier, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01523379
First received: January 31, 2012
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

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 Intervention
Causalgia
Drug: Parecoxib
Drug: Placebo

Study Type: Expanded Access     What is 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)

Resource links provided by NLM:


Further study details as provided by Ruhr University of Bochum:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Christoph Maier, Prof. Dr., Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01523379     History of Changes
Other Study ID Numbers: COX2009, 2009-009433-14
Study First Received: January 31, 2012
Last Updated: April 24, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ruhr University of Bochum:
Causalgia
CRPS
complex regional pain syndrome
Dynastat
Parecoxib

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

ClinicalTrials.gov processed this record on November 25, 2014