Pain related to the cannulation of arteriovenous fistula cannulation in haemodialysis patients.
Conditions
Interventions
Trade Name: XYLOCREAM
Pharmaceutical Form: Cream
INN or Proposed INN: LIDOCAINE
CAS Number: 137-58-6
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 2
Sponsors
Verisfield (UK) Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects fulfilling all of the following criteria may be included in the study: 1. Availability of the subject for the entire duration of the study period; 2. Ability to comprehend and be informed of the nature of the study; 3. Read and sign the informed consent form (ICF) as well as willingness to adhere to the protocol requirements; 4. Males and females of at least 18 years of age, undergoing chronic haemodialysis; 5. Ability to understand and use the Visual Analogue Scale to rate his/her pain. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded from the study: 1. Known allergies or sensitivities to lidocaine, prilocaine, or other local anaesthetic; 2. Congenital or idiopathic form of methaemoglobinemia; 3. Participation in any other clinical trial involving investigational products within 30 days prior to enrolment or intention to participate in another clinical trial involving investigational products during participation in this study; 4. Damaged, denuded, or broken skin at the designated site; 5. Concomitant use of an analgesic within the previous 24 hours; 6. Previous use of lidocaine/prilocaine cream; 7. Female subjects who are pregnant or breast-feeding; 8. Any other condition or situation that in the opinion of the study physician would make the subject unsuitable for enrolment or could interfere with the subject participating in and completing the study, such as known psychiatric, visual or neurologic disorders which can influence the assessment of pain.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to establish the therapeutic equivalence of local therapy with Lidocaine + Prilocaine/Verisfield (2.5+2.5)% w/w cream to that of the EMLA/AstraZeneca (2.5+2.5)% cream, in the management of pain associated with arteriovenous fistula cannulation in patients undergoing chronic haemodialysis using the Visual Analogue Scale (VAS).;Secondary Objective: -Testing the superiority of Lidocaine+Prilocaine/Verisfield (2.5+2.5)% w/w cream, to that of the placebo cream, in the management of pain associated with arteriovenous fistula cannulation using the VAS. -Testing the superiority of EMLA/AstraZeneca (2.5+2.5)% w/w cream, to that of the placebo cream, in the management of pain associated with arteriovenous fistula cannulation using the VAS. -Comparing the efficacy of Lidocaine + Prilocaine/Verisfield (2.5+2.5)% w/w cream to that of the EMLA/AstraZeneca (2.5+2.5)% w/w cream, in the management of pain associated with arteriovenous fistula cannulation using a Verbal Rating Scale (VRS). -Assessing the difference in the efficacy of EMLA/AstraZeneca (2.5+2.5)% w/w cream, compared to the placebo cream in the management of pain associated with arteriovenous fistula cannulation using the VRS scale. -Comparing the safety profile of Lidocaine + Prilocaine/Verisfield (2.5+2.5)% w/w cream versus that of EMLA/AstraZeneca (2.5+2.5)% w/w cream.;Primary end point(s): The primary endpoint of this study is the determination of the difference in the mean VAS scores (mm) between the local treatment with Lidocaine + Prilocaine/Verisfield (2.5+2.5)% w/w cream and the reference treatment EMLA/AstraZeneca cream, as recorded by the eligible study population undergoing chronic haemodialysis immediately following the insertion of the cannula in the arteriovenous fistula.;Timepoint(s) of evaluation of this end point: The pain assessment, using VAS, will be performed immediately following the arteriovenous fistula cannulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The first secondary endpoint pertains to the determination of the difference in the mean VAS scores (mm) between the Lidocaine+Prilocaine/Verisfield (2.5+2.5)% treatment and the placebo. - The second secondary endpoint pertains to the determination of the difference in the mean VAS scores (mm) between the EMLA/AstraZeneca (2.5+2.5)% treatment and the placebo. - The third secondary endpoint is the assessment of the difference between the Verbal Rating Scale (VRS) score of the Lidocaine + Prilocaine/Verisfield (2.5+2.5)% w/w cream and that of the EMLA/AstraZeneca cream. - The fourth secondary endpoint is the assessment of the difference between the VRS score of the EMLA/AstraZeneca (2.5+2.5)% w/w cream and that of the placebo cream. - Finally, the fifth secondary endpoint is to compare the frequencies of adverse drug reactions occurred with local therapy with Lidocaine + Prilocaine/Verisfield (2.5+2.5)% w/w cream versus those of EMLA/AstraZeneca (2.5+2.5)% w/w cream. ;Timepoint(s) of evaluation of this end point: The pain assessment, using VAS and/or VRS, will be performed immediately following the arteriovenous fistula cannulation. The safety assessment will be performed during each visit of the patient at the site. | — |
Countries
Greece
Contacts
Public ContactGeneral Manager
Verisfield
Outcome results
None listed