CausalgiaPhase 2NCT01088256
Efficacy of Etoricoxib on Peripheral Hyperalgesia
A Phase 2 study testing Etoricoxib in people with Causalgia and Polyneuropathy, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
The purpose of the study is to determine the efficacy of etoricoxib on pain patients. The investigators assume that patients with neuropathic pain will have greater pain relief then patients on placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Causalgia, Polyneuropathy, Postherpetic Neuralgia
- What is being tested?
- Etoricoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to Aug 2012
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years with
- Persistent moderate or severe pain (> 4 on NRS (1..10)) at rest (average of three daily assessments using a diary for at least two days) .
- Neuropathic pain associated with a clinical and neurologically proven peripheral nerve injury, radiculopathy, postherpetic neuralgia or polyneuropathy or CRPS
- One of the two following QST phenotypes at the baseline assessment:
- signs of peripheral hyperalgesia (that means, pathological decreased heat pain threshold and/or pathological decreased muscle pain threshold)
- without signs of peripheral hyperalgesia (no pathological decreased heat - and/or muscle pain threshold)
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- Patients of both gender
- Signed consent form
- Patients with the ability to understand and follow the instructions of the doctor
Who cannot join
- Excluded will be patients Parkinson's disease or a history of cerebral vascular insult or nerve injury.
- Excluded will be also all patients with contradictions for the use of Etoricoxib:
- Hypersensitivity to the active substance or to any of the excipients.
- Active peptic ulceration or active gastrointestinal (GI) bleeding.
- Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetyl-salicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
- Pregnancy and lactation
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- Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10).
- Estimated renal creatinine clearance <30 ml/min.
- Inflammatory bowel disease.
- Congestive heart failure (NYHA II-IV).
- Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled
- Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
- 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
- immunosuppressives
- TNF-α-inhibitors
Trial locations and contacts
1 site in 1 country.
Germany1 site
Bergmannsheil department of pain therapy
Bochum, North Rhine-Westphalia, 44789
About this study
Official title: Efficacy of Etoricoxib in Patients With Neuropathic Pain With and Without Peripheral Hyperalgesia - A Prove of Concept Trial
The purpose of the study is to determine the efficacy of etoricoxib on pain patients. The investigators assume that patients with neuropathic pain will have greater pain relief then patients on placebo.
Read the detailed description
Animal experiments analysing anti-hyperalgesic effects of Coxibs show inconsistent results due to different used dosages and varying different pain models. Theoretical the use of NSAIDs is rational, particularly of Coxibs as a part of the neuropathic pain management. But in the newest topical review, there is no valid information available about the effectiveness of these drugs in human neuropathic pain models or in patients with different underlying mechanism, e.g. with or without hyperalgesia.
- Being tested
- Etoricoxib, placebo
- Keywords
- CRPS, Morbus Sudeck, Causalgia, Etoricoxib, Polyneuropathy, post herpetic neuralgia, peripheral nerve injury, radiculopathy, Nervenverletzung, postherpetische Neuralgie, COX-2-Inhibitor
- Medical subject headings
- Causalgia, Polyneuropathies, Neuralgia, Postherpetic, Peripheral Nerve Injuries, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoricoxibDrug
Also called Arcoxia
the patients get etoricoxib 90mg for 8 days. They get one pill with 90mg per day
placeboDrug
patients get one pill of placebo (sugar-pill) per day for 8 days.
| Study group | Role | What they receive |
|---|---|---|
| etoricoxib, peripheral hyperalgesia | Active comparator | 14 patient with neuropathic pain and peripheral hyperalgesia get etoricoxib 90mg for 8 days Receives: Drug: Etoricoxib |
| etoricoxib, no peripheral hyperalgesia | Active comparator | 14 patients with neuropathic pain without peripheral hyperalgesia get etoricoxib 90mg for 8 days Receives: Drug: Etoricoxib |
| placebo, peripheral hyperalgesia | Placebo comparator | 14 patients with neuropathic pain with peripheral hyperalgesia get placebo for 8 days Receives: Drug: placebo |
| placebo, no peripheral hyperalgesia | Placebo comparator | 14 patients with neuropathic pain without peripheral hyperalgesia get placebo for 8 days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superior improvement of peripheral hyperalgesia at day six after initiation of Cox-2-inhibiting-medication in comparison to placebo
Measured: 12 month
Secondary outcomes (1)
Reduction of the average on-going pain
reduction of the average on-going pain decrease of the neuropathic symptoms intensity (NPSI score) decrease of the patients global impression of change (PGIC) decrease of the frequency and cumulative 7 day dosage of rescue medication
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startFeb 2011
- Primary completionAug 2012
- Study completionAug 2012
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Maier, Prof. Dr., Ruhr University of Bochum
- Investigators
- Christoph Maier, Dr.med, Study director, University hospital Bergmannsheil department of pain therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088256
- Sponsor's protocol ID
- Etoricox09-10
- Other IDs
- 2009-015496-27, 2009
- Status last verified
- Aug 2012
- First submitted
- 16 Mar 2010
- Last updated
- 24 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Etoricoxib in Patients With Neuropathic Pain With and Without Peripheral Hyperalgesia - A Prove of Concept Trial
- ClinicalTrials.gov ID
- NCT01088256
- Acronym / sponsor ID
- Etoricox09-10
- Keywords
- CRPS, Morbus Sudeck, Causalgia, Etoricoxib, Polyneuropathy, post herpetic neuralgia, peripheral nerve injury, radiculopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 17 Mar 2010 (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 purpose of the study is to determine the efficacy of etoricoxib on pain patients. The investigators assume that patients with neuropathic pain will have greater pain relief then patients on placebo.
Detailed description
Animal experiments analysing anti-hyperalgesic effects of Coxibs show inconsistent results due to different used dosages and varying different pain models. Theoretical the use of NSAIDs is rational, particularly of Coxibs as a part of the neuropathic pain management. But in the newest topical review, there is no valid information available about the effectiveness of these drugs in human neuropathic pain models or in patients with different underlying mechanism, e.g. with or without hyperalgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| etoricoxib, peripheral hyperalgesia | Active comparator | Drug: Etoricoxib14 patient with neuropathic pain and peripheral hyperalgesia get etoricoxib 90mg for 8 days |
| etoricoxib, no peripheral hyperalgesia | Active comparator | Drug: Etoricoxib14 patients with neuropathic pain without peripheral hyperalgesia get etoricoxib 90mg for 8 days |
| placebo, peripheral hyperalgesia | Placebo comparator | Drug: placebo14 patients with neuropathic pain with peripheral hyperalgesia get placebo for 8 days |
| placebo, no peripheral hyperalgesia | Placebo comparator | Drug: placebo14 patients with neuropathic pain without peripheral hyperalgesia get placebo for 8 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients over 18 years with
- Persistent moderate or severe pain (> 4 on NRS (1..10)) at rest (average of three daily assessments using a diary for at least two days) .
- Neuropathic pain associated with a clinical and neurologically proven peripheral nerve injury, radiculopathy, postherpetic neuralgia or polyneuropathy or CRPS
- One of the two following QST phenotypes at the baseline assessment:
- Patients of both gender
Key exclusion criteria (23 listed)
- Excluded will be patients Parkinson's disease or a history of cerebral vascular insult or nerve injury.
- Hypersensitivity to the active substance or to any of the excipients.
- Active peptic ulceration or active gastrointestinal (GI) bleeding.
- Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetyl-salicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
- Pregnancy and lactation
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 |
|---|---|---|
| EtoricoxibAlso: Arcoxiathe patients get etoricoxib 90mg for 8 days. They get one pill with 90mg per day | Drug | etoricoxib, no peripheral hyperalgesia, etoricoxib, peripheral hyperalgesia |
| placebopatients get one pill of placebo (sugar-pill) per day for 8 days. | Drug | placebo, no peripheral hyperalgesia, placebo, peripheral hyperalgesia |
Primary outcome
Superior improvement of peripheral hyperalgesia at day six after initiation of Cox-2-inhibiting-medication in comparison to placebo
Time frame: 12 month
1 secondary outcome
Reduction of the average on-going pain
Time frame: 12 month
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 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.
Christoph Maier, Dr.med study director
University hospital Bergmannsheil department of pain therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etoricoxib in people with Causalgia and Polyneuropathy, run by Ruhr University of Bochum at 1 site in Germany.
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 9 inclusion and 23 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: stopped early, as of the sponsor's last update on 24 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. 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.
What does the primary outcome measure?
Superior improvement of peripheral hyperalgesia at day six after initiation of Cox-2-inhibiting-medication in comparison to placebo (time frame: 12 month). It is what the study was designed to measure, not a finding.
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 24 Aug 2012.