Experimental Medicine Study to Validate Pharmacodynamic Pain Assessments in Healthy Volunteers With an Opioid Analgesic (Remifentanil)

Pain Clinical Trial

Official title: Experimental Medicine Study to Validate Pharmacodynamic Pain Assessments in Healthy Volunteers in a Randomised, Double Blind, Placebo Controlled, 2 Way Cross-over Design With an Opioid Analgesic (Remifentanil)

Status Completed

Clinical Trial Summary

This was a single centre, randomised, double blind, placebo controlled, two-way cross-over design study to assess the feasibility of pain PD tests and to determine the variability and effects of a known analgesic drug (the opioid remifentanil) in South Korean healthy volunteers.

Clinical Trial Description

Pain is an area of large unmet medical need and a priority disease area for GlaxoSmithKline. Selection of new candidates for pain involves tests in animal models; however, their predictive value may be limited. High risks are carried forward into Phase II Proof of Concept (PoC) studies that require large financial and time commitments.

Assessment of pain in Phase I studies can serve as a useful indicator of pharmacodynamic activity of potential analgesic treatments to reduce development risks, help make decisions about further compound progression, dose selection and design of clinical studies in pain patients. GlaxoSmithKline's Pain & Neurophysiology group at Clinical Unit Cambridge (CUC) has developed a number of human pain models specifically tailored for GSK's portfolio and began their implementation into clinical development. Some of these models have already been used successfully to detect PD activity in Phase I [Chizh, 2007] Currently, for most candidates selected by the neurology Centre for Excellence in Drug Discovery (CEDD, there are plans to utilise human pain models as part of clinical development, including FTIH studies. Because of the limited in-house capacities, there is an ongoing effort to identify a suitable external group(s) to which some of the methodologies in pain models and PD assessments could be transferred. Involving such external groups could also help access new patient groups, such that Phase I and Phase II experimental assessments could be facilitated to provide early indication of efficacy before large scale multi-centre trials are initiated.

South Korea has been identified as a country within the Asia-Pacific region to which GlaxoSmithKline would like to collaborate more closely in terms of early phase clinical trials, particularly First Time in Human studies. A satisfactory validation study will enable us to use these methodologies in future pain studies in order to link early efficacy assessments (Phase I) with future patient studies (Phase II) within South Korea.

One group that has been identified is the Clinical Trials Center of Seoul National University Hospital. This site is being considered to perform a number of clinical studies of potential new treatments for pain. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver)

Related Conditions & MeSH terms

• Pain

• NCT number: NCT02602002
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Completed
• Phase: Phase 1
• Start date: April 2008
• Completion date: June 2008