Comparison of Lidocaine 5% plasters and Pregabalin for the treatment of the painful condition called Complex Regional Pain Syndrome.

Phase 1

• Conditions: Complex regional pain syndrome type 1.; MedDRA version: 14.1Level: LLTClassification code 10064334Term: Complex regional pain syndrome Type ISystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2009-010557-12-GB
• Lead Sponsor: The Pennine Acute Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-14
• Study Completion: 2012-09-24
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 899999991

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified