Experimental Medicine Study to Validate Pharmacodynamic Pain Assessments in Healthy Volunteers With an Opioid Analgesic (Remifentanil)
Condition: Pain
Study type: Interventional
Phase: Phase 1

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.
    

Detailed 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.
    

Intervention name(s): Remifentanil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IV; Placebo
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Keywords: Remifentanil, Pharmacodynamic Pain assessments, Intravenous, South Korea