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
About this trial
This is an expanded access trial for Causalgia focused on measuring Causalgia, CRPS, complex regional pain syndrome, Dynastat, Parecoxib
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01523379
First Posted
January 31, 2012
Last Updated
April 24, 2012
Sponsor
Ruhr University of Bochum
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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