Study Stopped
Trial was stopped due to difficult enrolment
Lidocaine 5% Medicated Plaster in Chronic Neuropathic Postoperative Pain
2 other identifiers
interventional
74
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 pain
Started Aug 2010
Typical duration for phase_2 pain
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2010
CompletedFirst Posted
Study publicly available on registry
July 2, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedOctober 16, 2019
October 1, 2019
2.3 years
July 1, 2010
October 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic postoperative neuropathic pain
Participants will be selected based on their medical history and clinical examination. A questionnaire called DN4, which stands for 'douleur neuropathique 4' (i.e., '4 questions neuropathic pain will be used to identify subjects with neuropathic pain.) Pain will be assessed on and 11-point numerical rating scale (0 = no pain, 10 = worst pain imaginable). Efficacy of the treatment (i.e., reduction of neuropathic pain) will be evaluated with the 11-point numeric rating scale (NRS).
daily assessments over 4 weeks
Secondary Outcomes (6)
Effect of lidocaine 5% medicated plaster on quality of life
4 weeks
Neuropathic Pain Symptoms
4 weeks
Incidence of adverse events
up to 44 days
Hospital Anxiety and Depression Scale
4 weeks
Subject's Global Impression of Change
4 weeks
- +1 more secondary outcomes
Study Arms (2)
Placebo Plaster
PLACEBO COMPARATORActive Comparator
Lidocaine Plaster
ACTIVE COMPARATORInterventions
Topical hydrogel plaster (700mg lidocaine)
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Grünenthal GmbHlead
Study Sites (22)
Site 31
Abbeville, France
Site 26
Bayonne, France
Site 34
Bobigny, France
Site 35
Bordeaux, France
Site 12
Boulogne-Billancourt, France
Site 24
Brest, France
Site 15
Châteauroux, France
Site 30
Corbeil-Essonnes, France
Site 39
La Roche-sur-Yon, France
Site 23
Lille, France
Site 17
Limoges, France
Site 21
Marseille, France
Site 33
Montauban, France
Site 14
Nice, France
Site 18
Orléans, France
Site 27
Paris, France
Site 36
Paris, France
Site 22
Rennes, France
Site 20
Saint-Etienne, France
Site 19
Saint-Genis-Laval, France
Site 38
Tours, France
Site 28
Voiron, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Bruxelle
Fondation Ophtalmologique Adolphe de Rotschild, Service de Neurochirurgie, CEntre d'Evaluation et de Traitement de la Douleur
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2010
First Posted
July 2, 2010
Study Start
August 1, 2010
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
October 16, 2019
Record last verified: 2019-10