Efficacy of Etoricoxib on Peripheral Hyperalgesia

This study has been terminated.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Peripheral Nerve Injuries
Polyneuropathies
Radiculopathy
Autonomic Nervous System Diseases
Complex Regional Pain Syndromes
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Sensation Disorders
Signs and Symptoms
Somatosensory Disorders
Trauma, Nervous System
Wounds and Injuries
Etoricoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 20, 2014