INDIANAPOLIS—Researchers from Indiana University School of Medicine are studying the safety and efficacy of a drug combination for patients with chronic pancreatitis (CP). The phase 1 multi-site trial led by IU recently received $1.1 million in funding from the National Institutes of Health.
Chronic abdominal pain is the main symptom of CP, with 50-80 percent of patients seeking medical attention for pain management. While several analgesic options are available, opioids are the most effective. However, opioid-induced hyperalgesia (OIH), a phenomenon resulting in dose escalation, could occur. Researchers believe an anti-seizure drug called lacosamide could help.
“This drug combination may result in improved pain control with a decrease in opioid dosing necessary for pain relief,” said Fletcher White, MS, PhD, VK Stoelting Professor of Anesthesia for the IU School of Medicine Department of Anesthesia. White is also a primary investigator for the Stark Neurosciences Research Institute and a research scientist with the Richard L. Roudebush Veterans Affairs Medical Center. “This study is testing the safety, tolerability and dose-limiting toxicity of the combination of opioids and lacosamide.”
In pre-clinical and clinical trials with neuropathic pain, lacosamide in combination with opioids reduced both pain scores and dosing amount of the opioid necessary for pain relief. There are no data, however, evaluating the use of lacosamide in CP patients.
White is leading the study in Indianapolis along with Evan Fogel, MSc, MD, Stuart Sherman Professor of Gastroenterology and Hepatology for the IU School of Medicine Department of Medicine. There are five additional satellite sites, including Stanford University, Mayo Clinic, The Ohio State University, University of Pittsburgh and MD Anderson. Given the small sample size and strong potential for patient recruitment at IU and the other clinical centers across the nation, it is anticipated that all data will be accrued within 36 months of study initiation.
“Chronic, debilitating abdominal pain is the most common reason why patients with chronic pancreatitis are referred to gastroenterologists,” Fogel said. “While some patients may be candidates for endoscopic or surgical therapies, the majority of patients are managed medically, with analgesics. There is a need to identify safe and effective agents which can be added to our armamentarium.”
“Most of the pain management options available to these individuals often have disappointing efficacy, and opioids remain a mainstay of therapy,” White said. “Our hope is that this drug combination may provide greater efficacy of the opioid drug at a much lower dose. Essentially making for a safer, more effective pain drug.”
It is anticipated the results of this pilot study will support a phase 2 trial assessing the efficacy of lacosamide added to opioid therapy to alleviate abdominal pain from CP.
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IU School of Medicine is the largest medical school in the United States and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability.