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Efficacy of Parecoxib on Patients With CRPS

Primary Purpose

Causalgia

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Parecoxib
Placebo
Sponsored by
Ruhr University of Bochum
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Causalgia focused on measuring Causalgia, CRPS, complex regional pain syndrome, Dynastat, Parecoxib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 31, 2012
    Last Updated
    April 24, 2012
    Sponsor
    Ruhr University of Bochum
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01523379
    Brief Title
    Efficacy of Parecoxib on Patients With CRPS
    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)
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ruhr University of Bochum

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Causalgia
    Keywords
    Causalgia, CRPS, complex regional pain syndrome, Dynastat, Parecoxib

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Parecoxib
    Other Intervention Name(s)
    Dynastat
    Intervention Description
    90mg Parecoxib i.v. two times a day, two days in a row
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    sodium chlorid
    Intervention Description
    NaCl i.v. two times a day, two days in an row

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of Parecoxib on Patients With CRPS

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