Project Title: Study of Orofacial Pain and PropRANOlol (SOPPRANO)
Sponsor: NIH/National Institute of Dental and Craniofacial Research (NIDCR)
Prime: University of North Carolina at Chapel Hill (Subcontractor: Rho)
Project Status: Active
Project Start: September 2014
Diseases: Temporomandibular Joint Disorders, Craniomandibular Disorders, Jaw Diseases, Musculoskeletal Diseases, Joint Diseases, Muscular Diseases, Myofascial Pain Syndromes, Oral Diseases
Objective: The primary objective of the SOPPRANO study is to evaluate the efficacy of extended-release propranolol compared to placebo for reducing pain in patients with temporomandibular disorder (TMD). There is currently no FDA-approved product labeled specifically to manage/treat TMD; however, classes of drugs are used to relieve TMD-associated pain, such as non-steroidal anti-inflammatory drugs (NSAIDs), anti-inflammatory drugs, corticosteroids, benzodiazepines, sedative hypnotics, muscle relaxants, opioids, antidepressants, and anticonvulsants—although evidence to establish their efficacy and safety in this population is scarce. Practitioners’ justification for their use may be based on poorly controlled clinical trials or clinical trials in other pain disorders, such as acute postsurgical dental pain, arthritic pain, chronic lower back pain, and neuropathic pain. Thus, there is a need for controlled clinical trials to better understand the physiological mechanisms responsible for TMD symptoms.
Project Information: Rho serves as the Data Coordinating Center for the 3-clinical site SOPPRANO study. Our responsibilities encompass a broad range of functions, including clinical project management, data collection and management, statistical design and analysis, clinical operations and monitoring, and product safety and pharmacovigilance services. At the conclusion of the study, Rho will also support the production of study manuscripts.
- Clinical Project Management
- Clinical Data Management
- Biostatistics and Statistical Programming
- Clinical Operations And Monitoring
- Product Safety and Pharmacovigilance Services