Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2009-010557-12-GB
EUCTR2009-010557-12-GB
Active, not recruiting
Phase 1

A Single Blind, Randomised, Cross-over Study to Compare the Efficacy of Lidocaine 5% Plasters(Versatis) versus Pregabalin (Lyrica) in the Treatment of Complex Regional Pain Syndrome, Type 1. - Lidocaine vs. pregabalin in CRPS

The Pennine Acute Hospitals NHS Trust0 sites899,999,991 target enrollmentOctober 14, 2009
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsComplex regional pain syndrome type 1.MedDRA version: 14.1Level: LLTClassification code 10064334Term: Complex regional pain syndrome Type ISystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsVersatis 5% Medicated PlasterLyrica

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Complex regional pain syndrome type 1.
Sponsor
The Pennine Acute Hospitals NHS Trust
Enrollment
899999991
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 14, 2009
End Date
September 24, 2012
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
The Pennine Acute Hospitals NHS Trust

Eligibility 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.

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.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
A research study to compare two treatments for treating a respiratory disease known as asthma-COPD overlap syndrome (ACOS).
EUCTR2015-002046-31-HUMundipharma Research Limited130
Active, not recruiting
Phase 1
A research study to compare two treatments for treating a respiratory disease known as asthma-COPD overlap syndrome (ACOS).Fixed airflow obstruction with elevated eosinophilsMedDRA version: 18.1Level: LLTClassification code 10077006Term: Asthma-COPD overlap syndromeSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
EUCTR2015-002046-31-SKMundipharma Research Limited130
Active, not recruiting
Phase 1
A research study to compare two treatments for treating a respiratory disease known as asthma-COPD overlap syndrome (ACOS).Fixed airflow obstruction with elevated eosinophilsMedDRA version: 19.0Level: LLTClassification code 10077006Term: Asthma-COPD overlap syndromeSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
EUCTR2015-002046-31-PLMundipharma Research Limited130
Active, not recruiting
Phase 1
A research study to compare two treatments for treating a respiratory disease known as asthma-COPD overlap syndrome (ACOS).Fixed airflow obstruction with elevated eosinophilsMedDRA version: 18.1Level: LLTClassification code 10077006Term: Asthma-COPD overlap syndromeSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
EUCTR2015-002046-31-ESMundipharma Research Limited130
Active, not recruiting
Phase 1
Study of the effect and safety of a new immunoglobulin preparation (HyQvia) for subcutaneous usage in patients with Multifocal Motor NeuropathyMultifocal Motor Neuropathy (MMN)MedDRA version: 18.1Level: PTClassification code 10064135Term: Polyneuropathy chronicSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
EUCTR2015-003453-18-DKRigshospitalet20