Hyperalgesia Clinical Trial
Official title:
A Double-blind, Double-dummy, Placebo-controlled, Incomplete Block, Two Period Crossover Study of the Histamine H3 Antagonist GSK189254 and Duloxetine in the Electrical Hyperalgesia Model of Central Sensitisation in Healthy Volunteers
GSK189254 is a highly potent histamine 3 (H3) receptor antagonist which has demonstrated
efficacy in the reduction of mechanical hyperalgesia and allodynia in the chronic
constriction injury pre-clinical model of neuropathic pain (NP). The mechanism of action of
GSK 189254 in the pain model is hypothesised to be via enhanced release of monoamines in the
central nervous system (CNS). A similar mechanism of action has also been shown for
duloxetine. In this phase I study, the safety and efficacy of GSK189254 will be investigated
in the electrical hyperalgesia (EH) model in healthy volunteers to build confidence that the
preclinical efficacy demonstrated by this compound will translate into patients.
This study will be conducted as a double-blind, double-dummy, placebo-controlled, incomplete
block, two period crossover study. Up to 40 healthy male or female volunteers, aged 18-45
years old, will be randomised into the study in order to achieve 32 evaluable subjects.
Subjects will undergo two 3-week treatment periods and will be randomised to receive placebo
and either GSK189254 (up to 100µg once daily) or duloxetine (up to 60mg daily). There will be
a one week washout between treatment periods. The effects of repeated oral dosing of
GSK189254 and duloxetine on secondary hyperalgesia in the EH model will be determined.
Subject: GSK189254, Neuropathic pain (NP), H3 antagonist, duloxetine, Electrical
hyperalgesia, Phase I, Healthy volunteers, Double blind, Safety, tolerability.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01301079 -
Evaluation of the Effect of Ketamine on Remifentanil-induced Hyperalgesia
|
Phase 3 | |
| Completed |
NCT00833755 -
Effect of Ketamine on Opioid-Induced Hyperalgesia
|
N/A | |
| Completed |
NCT00279032 -
GW406381 In Patients With Peripheral Nerve Injury
|
Phase 1 | |
| Completed |
NCT03793790 -
The Role of Learning in Nocebo Hyperalgesia
|
N/A | |
| Completed |
NCT03985995 -
Pain Response to Cannabidiol in Induced Acute Nociceptive Pain, Allodynia and Hyperalgesia By Using a Model Mimicking Acute Pain in Healthy Adults
|
N/A | |
| Completed |
NCT04199858 -
Electrophysiological Correlates of Nocebo Effects on Pain
|
N/A | |
| Completed |
NCT02938455 -
DNA Methylation and Perioperative Pain Treatment
|
||
| Not yet recruiting |
NCT02934763 -
Opioid Induced Hyperalgesia (OIH) Modulation With Propranolol
|
Phase 4 | |
| Completed |
NCT02653703 -
L-menthol as a Topical Counter-irritant to TRPA1-induced Neurogenic Inflammation and Pain
|
N/A | |
| Completed |
NCT02253966 -
Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty
|
Phase 2 | |
| Completed |
NCT01702389 -
Opioid-induced Hyperalgesia After Remifentanil Infusion
|
Phase 4 | |
| Terminated |
NCT01615510 -
Evaluation of the Antihyperalgesic Effect of Tapentadol in Two Human Experimental Models
|
Phase 1 | |
| Completed |
NCT00218374 -
Dextromethorphan, Gabapentin, and Oxycodone to Treat Opioid-Induced Hyperalgesia
|
N/A | |
| Completed |
NCT04197154 -
Pain-related Fear as a Facilitator of Nocebo Hyperalgesia
|
N/A | |
| Completed |
NCT02976337 -
Effect of High-dose Naloxone Following Third Molar Extraction
|
Phase 2 | |
| Completed |
NCT03354624 -
Cortical Neuroplasticity by Muscle Pain of Pain-induced Plasticity
|
N/A | |
| Completed |
NCT02596360 -
Dextromethorphan Effect on Central Sensitization to Pain in Healthy Volunteers
|
Phase 1 | |
| Recruiting |
NCT01480765 -
Preventing Pain After Heart Surgery
|
Phase 4 | |
| Recruiting |
NCT01015482 -
The Effect of High-dose Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers (HighDose RemiSun)
|
Phase 4 | |
| Completed |
NCT01025245 -
Effect of Intraoperative Magnesium on Remifentanil-induced Postoperative Hyperalgesia After Thyroidectomy
|
Phase 4 |