CausalgiaNCT01523379
Efficacy of Parecoxib on Patients With CRPS
A study testing Parecoxib in people with Causalgia, run by Ruhr University of Bochum.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Causalgia
- What is being tested?
- Parecoxib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 24Show fewer
- 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
About this study
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)
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.
- Conditions
- Causalgia
- Being tested
- Parecoxib, Placebo
- Keywords
- Causalgia, CRPS, complex regional pain syndrome, Dynastat, Parecoxib
- Medical subject headings
- Causalgia, Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParecoxibDrug
Also called Dynastat
90mg Parecoxib i.v. two times a day, two days in a row
PlaceboDrug
Also called sodium chlorid
NaCl i.v. two times a day, two days in an row
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CausalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Maier, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523379
- Sponsor's protocol ID
- COX2009
- Other IDs
- 2009-009433-14, 2009
- Status last verified
- Apr 2012
- First submitted
- 31 Jan 2012
- Last updated
- 25 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01523379
- Acronym / sponsor ID
- COX2009
- Conditions
- Causalgia
- Keywords
- Causalgia, CRPS, complex regional pain syndrome, Dynastat, Parecoxib
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- First posted
- 1 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (24 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParecoxibAlso: Dynastat90mg Parecoxib i.v. two times a day, two days in a row | Drug | – |
| PlaceboAlso: sodium chloridNaCl i.v. two times a day, two days in an row | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Parecoxib in people with Causalgia, run by Ruhr University of Bochum.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2012.