Naproxen + Pregabalin for Acute Pain

This trial aims to test how two medications, pregabalin (a nerve pain medication) and naproxen (a nonsteroidal anti-inflammatory drug), relieve different types of pain in the body. Researchers will use a series of short, controlled pain tests to observe how these drugs affect pain responses. The trial will involve up to 25 healthy adults, each trying pregabalin, naproxen, and a placebo in different sequences. Suitable candidates are healthy individuals who can handle brief cold, heat, and pressure tests and report moderate pain during these assessments. While the study will not provide direct medical benefits to participants, it will aid in improving future pain treatment testing. As an unphased trial, this study offers participants the opportunity to contribute to foundational research that could shape future pain management therapies.

Yes, you must stop taking any prescription medications, except for hormonal contraceptives or hormone replacement therapy, starting 14 days before the first dose of the study medication and throughout the study, unless approved by the Investigator.

Previous studies have shown that single doses of naproxen, such as the 550 mg dose used here, are safe and effective for treating sudden pain. Research indicates that short-term use of naproxen does not increase the risk of side effects compared to a placebo.

Studies have shown that pregabalin is generally well-tolerated. While some side effects like dizziness or sleepiness can occur, its overall safety remains manageable. Pregabalin has been used for over ten years, and its side effects are well-known and consistent.

Researchers are excited about using Naproxen and Pregabalin for acute pain because these medications could offer a more effective pain relief strategy than current options. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) known for reducing inflammation and pain, while Pregabalin acts by calming overactive nerves. This combination could potentially offer quicker and more comprehensive pain relief by targeting both pain and inflammation simultaneously. Unlike some current treatments that might focus on either pain or inflammation alone, this duo promises a more well-rounded approach. This could mean faster relief with potentially fewer doses needed.

This trial will evaluate the effectiveness of naproxen and pregabalin for acute pain. Studies have shown that naproxen effectively relieves various types of sudden pain, with about half of the users experiencing at least a 50% reduction in pain within four to six hours. Pregabalin also reduces pain, particularly nerve-related pain and post-surgical pain, by lowering pain levels and decreasing the need for other pain medications. Naproxen reduces inflammation in the body, while pregabalin affects the brain and spinal cord to manage pain. Participants in this trial will receive different sequences of these treatments to assess their effectiveness.¹³⁶⁷⁸