Status:
TERMINATED
Lidocaine 5% Medicated Plaster in Chronic Neuropathic Postoperative Pain
Lead Sponsor:
Grünenthal GmbH
Conditions:
Pain
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain in comparison to placebo plaster.
Detailed Description
Some patients who undergo different types of surgery develop distressing and long-lasting pain. This pain is often characterized by signs such as: allodynia (a pain due to a stimulus which does not no...
Eligibility Criteria
Inclusion
- Male or female subjects with \>= 18 years of age
- Intact skin in the area of topical treatment
- Patients suffering from moderate to severe ( 5 or more points on an 11 point Numerical Rating Scale where 10 is the worst possible pain, and 0 indicates no pain) chronic daily postoperative neuropathic pain for the past 6 to 24 months.
- Patients should have symptoms for example allodynia (a pain due to a stimulus which does not normally provoke pain); and or dysesthesia (unpleasant, abnormal sense of touch).
Exclusion
- Contraindications to lidocaine 5% medicated plaster, or paracetamol
- Evidence or history of alcohol, medication or drug abuse and/or dependency in the past 3 years.
- Evidence or history (during the past 3 years) of epilepsy, neurotic personality, psychiatric illness, or suicide risk.
- Pregnant or breastfeeding women
- Women of childbearing potential who are sexually active without satisfactory contraception for at least 28 days prior to enrollment, during the trial, and until 28 days after the follow-up visit.
- Severe renal, hepatic or heart disorder.
- Surgery in the past 3 months before screening.
- Anticipated need for surgery during the trial, requiring at least regional or general anesthesia.
- Pending litigation due to chronic pain or disability.
- Participation in another trial of investigational medicinal products or devices parallel to or less than 1 month before entry into the trial, or previous participation in this trial.
- Presence of other severe pain that could confound the assessment or self- evaluation of the localized postoperative neuropathic pain.
- For patients with chronic postoperative neuropathic pain related to a surgery due to tumors: suspected residual tumor or metastases, chemotherapy or radiotherapy for treatment of tumor(s).
- Total anesthesia in the area of localized chronic pain
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01155986
Start Date
August 1 2010
End Date
November 1 2012
Last Update
October 16 2019
Active Locations (22)
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1
Site 31
Abbeville, France
2
Site 26
Bayonne, France
3
Site 34
Bobigny, France
4
Site 35
Bordeaux, France