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)

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.

Study Overview

• Status: No longer available
• Conditions: Causalgia
• Intervention / Treatment: Drug: Parecoxib; Drug: Placebo

• Study Type: Expanded Access

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum

Study record dates

Study Major Dates

• Study Start: December 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: January 31, 2012
• First Submitted That Met QC Criteria: January 31, 2012
• First Posted (Estimate): February 1, 2012

Study Record Updates

• Last Update Posted (Estimate): April 25, 2012
• Last Update Submitted That Met QC Criteria: April 24, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: CRPS; Causalgia; complex regional pain syndrome; Dynastat; Parecoxib
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Autonomic Nervous System Diseases; Complex Regional Pain Syndromes; Causalgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Parecoxib
• Other Study ID Numbers: COX2009; 2009-009433-14 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No