Complex regional pain syndrome type 1. MedDRA version: 14.1 Level: LLT Classification code 10064334 Term: Complex regional pain syndrome Type I System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Versatis 5% Medicated Plaster
Product Name: Lidocaine 5% Plaster
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: LIDOCAINE
CAS Number: 137-58-6
Other descriptive name: versatis
Sponsors
The Pennine Acute Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria at the week 0 visit will be eligible for this study. 1. Patients diagnosed with Complex Regional Pain Syndrome, type 1 2. Patients aged >18 years. 3. Patients who have had pain for > 3 months in duration. 4. Patients who have an average pain intensity > 4 in 0-10 numerical rating scale (question 4 of the BPI), 0 being no pain and 10 being the worst pain one can imagine. 5. Patients who are on a stable consumption (no change in medication or dosage) of pain medication for at least one month before the beginning of the study. Treatment may have included conventional neuropathic pain medications such as tricyclic antidepressants, antiepileptics (excluding gabapentin and pregabalin), tramadol, strong opioids and capsaicin but not lidocaine plasters or pregabalin. 6. Patients who have stopped taking gabapentin for at least one month prior to the study start date, if gabapentin formed part of their previous treatment. 7. Female patients who fulfil one of the following three criteria: • Post-menopausal, defined as amenorrhoea for at least 24 months together with an appropriate clinical profile (i.e., no alternative medical cause). • Not of child-bearing potential with a documented history of irreversible surgical sterilisation. • Of child-bearing potential with negative serum pregnancy test at week 0 visit and must have a history of consistent use of a highly effective method of birth control for the previous 3 months and be prepared to continue its use throughout the study and for 3 months after study completion. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: A patient will not be eligible for inclusion in this study if any of the following criteria apply. The following criteria should be assessed at the week 0 visit. 1. Patients with any other form of pain other than CRPS of similar or greater intensity. 2. Previous use of either lidocaine plasters or pregabalin for CRPS or any other type of pain 3. Patients who have a skin infection, inflammation or injuries with broken skin or insufficient wound healing at the site of application of the lidocaine plaster. 4. Patients with a history of sensitivity to lidocaine or pregabalin. 5. Patients who are receiving mexiletine, tocainide or other local anaesthetic medications. 6. Patients taking any other form of topical medications for pain relief 7. Patients on monoamine oxide inhibitors (MAOIs). 8. Patients with a clinically relevant history or presence of dementia, severe depression or severe renal or hepatic impairment. 9. Female patients who are pregnant or lactating. 10. Patients judged to be unreliable or unable to understand the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to compare the analgesic efficacy of lidocaine 5% plaster and pregabalin as measured from the Brief Pain Inventory in complex regional pain syndrome type 1.;Secondary Objective: The secondary objectives are: • To compare the responses to the quality of life issues, general activity, mood, walking ability, normal work, sleep, etc, as measured by the non-pain component of BPI, for Lidocaine 5% plaster and Pregabalin. • To compare the tolerability of Lidocaine 5% plaster and Pregabalin by the presence or absence of adverse effects and their severity (mild, moderate or severe). • To compare the area and threshold for mechanical allodynia using von Frey’s hairs for Lidocaine 5% plaster and Pregabalin. • To compare the results of Patient Global Impression of Change (PGIC), to Lidocaine 5% plaster and Pregabalin.;Primary end point(s): The main outcome measures will be reduction in pain intensity rating and pain relief as measured from the Brief Pain Inventory (BPI).;Timepoint(s) of evaluation of this end point: Pain intensity rating and pain relief will be measured at the following timepoints, Visits 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 at Weeks 0, 2, 4, 6, 8, 10, 12,14, 16, 18 and 20 respectively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Non-pain components are measured using the brief pain inventory at the following timepoints, Visits 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 at Weeks 0, 2, 4, 6, 8, 10, 12,14, 16, 18 and 20 respectively. Mechanical allodynia is measured by von Frey's hairs at the following timepoints, Visits 0, 4 and 10 at weeks 0, 8 and 20 respectively. The Change in Patient Global Impression Scale is measured at the following timepoints, Visits 4 and 10 at weeks 8 and 20. Visits ;Secondary end point(s): Measurement of change in non-pain components by the non-pain component of the Brief Pain Inventory Measurement of area and threshold of Mechanical Allodynia Measurement of change in the patient global impression scale | — |
Countries
United Kingdom
Contacts
Public ContactResearch and Development Dept.
The Pennine Acute Hospitals NHS Trust
Outcome results
None listed