Trial investigating the effects of injection volume and needle length.
Research type
Research Study
Full title
A Randomised Study to Investigate the Effects of Injection Volume and Needle Length on Pain and Injection Site Reactions in Healthy Subjects.
IRAS ID
260890
Contact name
Firas Almazedi
Contact email
Sponsor organisation
Eli Lilly & Company Limited
Duration of Study in the UK
0 years, 2 months, 26 days
Research summary
It has been noted that pain around injection sites has been a recurring adverse event in studies where a drug is administered as injections. It is thought that the needle penetration of the skin and injection liquid activate the sensory nerves which in turn causes pain. Previous studies by the sponsor have investigated this phenomenon and determined the combination of buffer solutions and other agents affected injection site pain and the impact of different buffer solutions respectively.
This study will be a single-centre, randomized, subject-blinded, crossover study in healthy subjects to test the delivery of buffer containing hyaluronic acid as a viscosity agent, at different volumes with different needle lengths using clinical infusion syringe pumps and infusion sets both of which are commercially available.This study will compare pain and other injection site reactions (ISRs) such as redness and swelling and will have two cohorts based on the thickness of subcutaneous (SC) tissue, lean and not lean. Subjects aged between 18 and 75 with a body mass index (BMI) between 17.5 and 35 kg/m2 will be assigned based on their ultrasonically measured SC tissue. Daily injections of buffer and hyaluronic acid (a viscosity agent) will be administered, a total of six per subject. Pain after injection will be assessed using the Short-Form McGill Pain Questionnaire (SFMPQ). Additional assessments will be made of redness hardness itching and swelling using a 3D camera.
The total length of the study is estimated at 7.5 weeks from screening to follow-up telephone call with six days’ residence in the Clinical Research Centre (CRU). No active drug is to be used in this study.
REC name
North East - York Research Ethics Committee
REC reference
19/NE/0136
Date of REC Opinion
29 May 2019
REC opinion
Further Information Favourable Opinion