PAIN MODELS

Our Experience

• Broad range of clinical pharmacology studies on analgesic drugs, narcotic and non-narcotic, including:
  • First-in-Human (FIH) – single and multiple ascending dose
  • Proof-of-Concept as part of FIH with a number of pain models
  • Phase II dose-ranging studies exploring safety and efficacy
• Different pain models used to assess pain due to neuropathy or inflammation, and tolerance at varying pain intensities following a multi-dose treatment as per the FDA guidance
• Pain models in healthy participants or patient populations
• A wide range of pain scores using objective measures, questionnaires or visual analogue scales

Altasciences Clinical Research has been engaged in clinical pharmacology studies on pain medication for almost 20 years. Our experience includes the completion of pharmacokinetic (PK) studies to demonstrate equivalence between two formulations, as well as studies on extended release and transdermal formulations. In the past 10 years, our experience has extended to the assessment of parameters for PK and pharmacodynamics (PD) on stand-alone studies and as part of a FIH protocol. The PD measures we have examined include abuse liability, cognition, biological biomarkers, as well as a number of different pain assessments in healthy volunteers and select patient populations.

The pain models we have tested examine various aspects of pain depending on the target of the compound, such as neuropathy or inflammation. Also, the models can focus on peripheral or central sensitization looking at allodynia or hyperalgesia. Our scientists are accustomed to designing studies and providing feedback on synopses or protocols provided. We have a number of key opinion leaders with whom we consult, as needed.

Patient Access

• 800+ patients with chronic pain disorders
• Lead recruitment and enrollment site for patients with osteoarthritis of the knee
• Collaboration with highly experienced knee surgeon for study setup and endpoint evaluation
• Easy access to healthy subjects through database of over 225,000 participants
• Ongoing outreach efforts to maintain and increase patient database

Clinical Expertise

• Full project management for multi-site trials, including training sites on recruitment and/or pain models
• Pain Models
  • Heat pain threshold and heat pain tolerance assessment
  • TENS, cold pain, mechanical stimulation model and cutaneous freeze injury
• Administration of medication via multiple routes, including parenteral injections

Case Studies

Study on Analgesia on Visceral Pain, Rectal Sensory Threshold Using the Barostat Method

A Proof-of-Concept Study Assessing NEO6860 in Osteoarthritis Pain

Support Services

Bioanalysis

• Our 20,000-sq.-ft. GLP-compliant LC/MS/MS/MS and ligand binding facility for preclinical to phase IV Support
• Method feasibility, transfer, development and validations in multiple matrices

PK/PD Analysis

• Comprehensive clinical PK and PD data analysis and interpretation
• Robust non-compartmental analysis using WinNonlin^® v6 (Phoenix)

Medical Writing

• Team with over 20 years of experience
• Study design in line with updated regulations
• Clinical trial protocol development
• Integrated ICH E3-compliant clinical study report (CSR)

Data Management

• Team with over 20 years of experience
• Medrio's eClinical EDC
• CDISC standards
• Medical coding using MedDRA and WHO-DDE

Project Management

• Project Manager oversees the complete program conduct and deliverables, from study protocol to reporting
• Extensive expertise in managing clinical trial sites and vendors

Biostatistics

• All programming completed using SAS® and is CDISC-compliant
• Randomization list, Statistical Analysis Plan, including mock TFLs
• Reconciliation of external data e.g. safety lab