Efficacy of Etoricoxib on Peripheral Hyperalgesia

NCT01088256 | Terminated Phase 2

• 2 other identifiers: Etoricox09-102009-015496-27
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Causalgia; Polyneuropathy; Postherpetic Neuralgia; Peripheral Nerve Injury; Radiculopathy

Keywords

CRPS; Morbus Sudeck; Causalgia; Etoricoxib; Polyneuropathy; post herpetic neuralgia; peripheral nerve injury; radiculopathy; Nervenverletzung; postherpetische Neuralgie; COX-2-Inhibitor

Outcome Measures

Primary Outcomes (1)

• Superior improvement of peripheral hyperalgesia at day six after initiation of Cox-2-inhibiting-medication in comparison to placebo

  12 month

Secondary Outcomes (1)

• Reduction of the average on-going pain

  12 month

Study Arms (4)

etoricoxib, peripheral hyperalgesia

ACTIVE COMPARATOR

14 patient with neuropathic pain and peripheral hyperalgesia get etoricoxib 90mg for 8 days

Drug: Etoricoxib

etoricoxib, no peripheral hyperalgesia

ACTIVE COMPARATOR

14 patients with neuropathic pain without peripheral hyperalgesia get etoricoxib 90mg for 8 days

Drug: Etoricoxib

placebo, peripheral hyperalgesia

PLACEBO COMPARATOR

14 patients with neuropathic pain with peripheral hyperalgesia get placebo for 8 days

Drug: placebo

placebo, no peripheral hyperalgesia

PLACEBO COMPARATOR

14 patients with neuropathic pain without peripheral hyperalgesia get placebo for 8 days

Drug: placebo

Interventions

Etoricoxib DRUG

the patients get etoricoxib 90mg for 8 days. They get one pill with 90mg per day

Also known as: Arcoxia

etoricoxib, no peripheral hyperalgesia; etoricoxib, peripheral hyperalgesia

placebo DRUG

patients get one pill of placebo (sugar-pill) per day for 8 days.

placebo, no peripheral hyperalgesia; placebo, peripheral hyperalgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Bergmannsheil department of pain therapy

Bochum, North Rhine-Westphalia, 44789, Germany

Location

MeSH Terms

Conditions

Causalgia; Polyneuropathies; Neuralgia, Postherpetic; Peripheral Nerve Injuries; Radiculopathy

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Complex Regional Pain Syndromes; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Christoph Maier, Dr.med

  University hospital Bergmannsheil department of pain therapy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: March 17, 2010
• Study Start: February 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 24, 2012

Record last verified: 2012-08

Locations

DE (1)