Lidocaine 5% Medicated Plaster in Chronic Neuropathic Postoperative Pain

• Status: Terminated
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grünenthal GmbH
• Treatments: Analgesics; Lidocaine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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