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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

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

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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