Human Pain Models
Human Pain Models at DVCR
Human pain models are conducted in volunteers in disease states undergoing a surgical procedure. The two most common models are bunionectomy and third molar extractions:
A bunion is a deformity marked by excess or misaligned bone in the first metatarsophalangeal joint. A bunionectomy involves excision of the medial aspect of the first metatarsal with osteotomy and internal fixation. This is considered a hard tissue model for assessing analgesic efficacy. As a pain model, bunionectomy has many desirable characteristics that include:
- Patient availability
- Predictable development and course of post-operative pain with known pathophysiology
- Prototypical analgesic response with minimal placebo response
- Analgesic requirements typically exceeding 7 days
- Osteotomy, which is critical for upside sensitivity
- Evaluation of various dosing regimens
- Assay sensitivity demonstrated under well controlled conditions
- Interpretable dose response and time effect curves
- Standardized surgical and anesthetic protocols
- Close monitoring and collection of standardized pain data
Third Molar Extraction
Third molar extraction is a well-characterized pain model that relies on healthy volunteers. Its assay sensitivity is high, and it is generally performed without potentially confounding systemic medications with central nervous system effects. With sufficient expertise, surgical protocols are adaptable to suit the study of low- and -high potency analgesic compounds. DVCR investigators have extensive experience with successful enrollment and on-site conduction of third molar studies and proficiency with controlling peri-operative variability.
The Dr. Vince Clinical Research team has broad expertise in pain therapeutics and with bunionectomy and third molar extraction pain models, led by our Executive Vice President, Scientific Affairs, Lynn R. Webster, MD, an internationally recognized clinical research expert in pain and addiction medicine. Since 2003, Dr. Webster has served as an investigator or co-investigator on over 350 clinical trials, giving him significant expertise in human pain models, experimental pain models, human abuse potential, and assessing drugs’ effects on respiratory depression.
DVCR’s trained staff and systematic quality control during each step of clinical trial execution are key to obtaining credible and reliable data. DVCR’s experienced investigators have proven success and expertise with design and execution of pain studies across the full drug development spectrum.
Reach Out Today
If you would like to learn more about how DVCR can support your upcoming human pain model assessment, please contact us.