Experimental Medicine Study to Validate Pharmacodynamic Pain Assessments in Healthy Volunteers With an Opioid Analgesic (Remifentanil)
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|ClinicalTrials.gov Identifier: NCT02602002|
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : November 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Remifentanil Drug: Placebo||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Care Provider)|
|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)|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
Remifentanil 0.1 ug/kg/min to 0.10 ug/kg/min
Placebo Comparator: Placebo
- To measure the Heat Pain Threshold of a marketed opioid analgesic versus placebo on quantitative experimental pharmacodynamic pain markers. [ Time Frame: pre-dose to 67 mins ]Heat pain threshold
- To measure the Mechanical Pain Threshold of a marketed opioid analgesic versus placebo. on quantitative experimental pharmacodynamic pain markers. [ Time Frame: Change from Baseline (pre-dose) in mechanical pain thresholds measurements at 46 minutes ]Mechanical pain threshold measurements (von Frey filaments) reported by treatment group and dose levels.
- To measure the Pressure Pain Threshold of a marketed opioid analgesic versus placebo on quantitative pharmacodynamic experimental pain markers. [ Time Frame: Change from Baseline (pre-dose) in mechanical pain thresholds measurements at 46mins ]Mechanical pain threshold measurements (von Frey filaments) reported by treatment group and dose levels.
- To measure the Mood and Alertness of a marketed opioid analgesic versus placebo on alertness on quantitative pharmacodynamic experimental pain markers. [ Time Frame: Change from Baseline (Pre-dose) in pressure pain thresholds and tolerance measurements at 46mins, 67 minutes ]Pressure pain threshold and tolerance measurements at 2 specified tender points reported by treatment group and dose levels. Mood and Alertness (Bond and Lader Visual Analogue Scale) presented graphically using box plots.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602002
|Korea, Republic of|
|GSK Investigational Site|
|Seoul, Korea, Republic of, 110-744|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|