Efficacy of Etoricoxib on Peripheral Hyperalgesia
This study has been terminated.
Sponsor:
Ruhr University of Bochum
Information provided by (Responsible Party):
Christoph Maier, Prof. Dr., Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01088256
First received: March 16, 2010
Last updated: August 23, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Causalgia Polyneuropathy Postherpetic Neuralgia Peripheral Nerve Injury Radiculopathy |
Drug: Etoricoxib Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy of Etoricoxib in Patients With Neuropathic Pain With and Without Peripheral Hyperalgesia - A Prove of Concept Trial |
Resource links provided by NLM:
Further study details as provided by Ruhr University of Bochum:
Primary Outcome Measures:
- Superior improvement of peripheral hyperalgesia at day six after initiation of Cox-2-inhibiting-medication in comparison to placebo [ Time Frame: 12 month ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Reduction of the average on-going pain [ Time Frame: 12 month ] [ Designated as safety issue: No ]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
| Enrollment: | 9 |
| Study Start Date: | February 2011 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: etoricoxib, peripheral hyperalgesia
14 patient with neuropathic pain and peripheral hyperalgesia get etoricoxib 90mg for 8 days
|
Drug: Etoricoxib
the patients get etoricoxib 90mg for 8 days. They get one pill with 90mg per day
Other Name: Arcoxia
|
|
Active Comparator: etoricoxib, no peripheral hyperalgesia
14 patients with neuropathic pain without peripheral hyperalgesia get etoricoxib 90mg for 8 days
|
Drug: Etoricoxib
the patients get etoricoxib 90mg for 8 days. They get one pill with 90mg per day
Other Name: Arcoxia
|
|
Placebo Comparator: placebo, peripheral hyperalgesia
14 patients with neuropathic pain with peripheral hyperalgesia get placebo for 8 days
|
Drug: placebo
patients get one pill of placebo (sugar-pill) per day for 8 days.
|
|
Placebo Comparator: placebo, no peripheral hyperalgesia
14 patients with neuropathic pain without peripheral hyperalgesia get placebo for 8 days
|
Drug: placebo
patients get one pill of placebo (sugar-pill) per day for 8 days.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
- Patients of both gender
- Signed consent form
- Patients with the ability to understand and follow the instructions of the doctor
Exclusion Criteria:
- 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088256
Locations
| Germany | |
| Bergmannsheil department of pain therapy | |
| Bochum, Nordrhein-Westfalen, Germany, 44789 | |
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
| Study Director: | Christoph Maier, Dr.med | University hospital Bergmannsheil department of pain therapy |
More Information
No publications provided
| Responsible Party: | Christoph Maier, Prof. Dr., Prof. Dr., Ruhr University of Bochum |
| ClinicalTrials.gov Identifier: | NCT01088256 History of Changes |
| Other Study ID Numbers: | Etoricox09-10, 2009-015496-27 |
| Study First Received: | March 16, 2010 |
| Last Updated: | August 23, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Ruhr University of Bochum:
|
CRPS Morbus Sudeck Causalgia Etoricoxib Polyneuropathy post herpetic neuralgia |
peripheral nerve injury radiculopathy Nervenverletzung postherpetische Neuralgie COX-2-Inhibitor |
Additional relevant MeSH terms:
|
Causalgia Hyperalgesia Neuralgia Neuralgia, Postherpetic Polyneuropathies Radiculopathy Complex Regional Pain Syndromes Autonomic Nervous System Diseases Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Somatosensory Disorders Sensation Disorders Neurologic Manifestations Signs and Symptoms |
Pain Etoricoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013