search
Back to results

Efficacy of Etoricoxib on Peripheral Hyperalgesia

Primary Purpose

Causalgia, Polyneuropathy, Postherpetic Neuralgia

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Etoricoxib
placebo
Sponsored by
Ruhr University of Bochum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Causalgia focused on measuring CRPS, Morbus Sudeck, Causalgia, Etoricoxib, Polyneuropathy, post herpetic neuralgia, peripheral nerve injury, radiculopathy, Nervenverletzung, postherpetische Neuralgie, COX-2-Inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bergmannsheil department of pain therapy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

etoricoxib, peripheral hyperalgesia

etoricoxib, no peripheral hyperalgesia

placebo, peripheral hyperalgesia

placebo, no peripheral hyperalgesia

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 16, 2010
Last Updated
August 23, 2012
Sponsor
Ruhr University of Bochum
search

1. Study Identification

Unique Protocol Identification Number
NCT01088256
Brief Title
Efficacy of Etoricoxib on Peripheral Hyperalgesia
Official Title
Efficacy of Etoricoxib in Patients With Neuropathic Pain With and Without Peripheral Hyperalgesia - A Prove of Concept Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
etoricoxib, peripheral hyperalgesia
Arm Type
Active Comparator
Arm Description
14 patient with neuropathic pain and peripheral hyperalgesia get etoricoxib 90mg for 8 days
Arm Title
etoricoxib, no peripheral hyperalgesia
Arm Type
Active Comparator
Arm Description
14 patients with neuropathic pain without peripheral hyperalgesia get etoricoxib 90mg for 8 days
Arm Title
placebo, peripheral hyperalgesia
Arm Type
Placebo Comparator
Arm Description
14 patients with neuropathic pain with peripheral hyperalgesia get placebo for 8 days
Arm Title
placebo, no peripheral hyperalgesia
Arm Type
Placebo Comparator
Arm Description
14 patients with neuropathic pain without peripheral hyperalgesia get placebo for 8 days
Intervention Type
Drug
Intervention Name(s)
Etoricoxib
Other Intervention Name(s)
Arcoxia
Intervention Description
the patients get etoricoxib 90mg for 8 days. They get one pill with 90mg per day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
patients get one pill of placebo (sugar-pill) per day for 8 days.
Primary Outcome Measure Information:
Title
Superior improvement of peripheral hyperalgesia at day six after initiation of Cox-2-inhibiting-medication in comparison to placebo
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Reduction of the average on-going pain
Description
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
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Maier, Dr.med
Organizational Affiliation
University hospital Bergmannsheil department of pain therapy
Official's Role
Study Director
Facility Information:
Facility Name
Bergmannsheil department of pain therapy
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44789
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Etoricoxib on Peripheral Hyperalgesia

We'll reach out to this number within 24 hrs