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CLINICAL TRIALS PROFILE FOR GRALISE

Clinical Trials for Gralise

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01301001	A Trial of Gabapentin in Vulvodynia: Biological Correlates of Response	Completed	University of Tennessee Health Science Center	N/A	The Specific aims of this project are to (1) test the prediction that pain from tampon insertion (primary outcome measure) is lower in PVD patients when treated with gabapentin compared to when treated with placebo. Secondary outcome measures include intercourse pain and 24-hour pain and (2)perform a mechanism-based analysis of gabapentin effectiveness, and to gain insight into the underlying pathophysiology of subtypes of PVD that may lead to more specific treatment options.
NCT01301001	A Trial of Gabapentin in Vulvodynia: Biological Correlates of Response	Completed	University of Tennessee	N/A	The Specific aims of this project are to (1) test the prediction that pain from tampon insertion (primary outcome measure) is lower in PVD patients when treated with gabapentin compared to when treated with placebo. Secondary outcome measures include intercourse pain and 24-hour pain and (2)perform a mechanism-based analysis of gabapentin effectiveness, and to gain insight into the underlying pathophysiology of subtypes of PVD that may lead to more specific treatment options.
NCT01623271	Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)	Terminated	Massachusetts General Hospital	N/A	The purpose of this study is to see if an FDA-approved drug (Gralise) can help people with certain types of neuropathic pain without causing too many side effects.
NCT01678911	Efficacy of Gralise® for Chronic Pelvic Pain	Terminated	Rehabilitation Institute of Chicago	Phase 4	This study is done to investigate the pain relieving effects of the study drug Gralise (a novel long acting gabapentinoid) for people who experience chronic pelvic pain. Subjects with Irritable Bowel Syndrome, Interstitial Cystitis, Ulcerative Colitis, and Prostatitis will be recruited. The purpose of this research is to look at how the study drug can be used to benefit people who experience this type of pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug has been approved by the Food and Drug Administration and has been reported to be well tolerated and effective in the treatment of various chronic pain conditions, particularly in neuropathic pain. About 36 subjects will take part in this study.
NCT01764464	GRASSP: Gralise® for Spine Surgery Pain	Recruiting	University of Rochester	Phase 4	Evaluate the analgesic benefit of Gralise® for post-laminectomy pain syndrome (PLPS)
NCT01776671	Once Daily Gabapentin in the Treatment of Post Amputation Pain	Recruiting	Chicago Anesthesia Pain Specialists	Phase 3	Phantom limb pain (PLP) is a common disorder reported by the patients who undergo amputation. Even though the cause of PLP remains unclear, Gabapentin has been widely used. The purpose of this study is to evaluate the accuracy and efficacy achieved in using of extended release Gabapentin. Reducing the incidence of chronic post-amputation pain and improving clinical outcomes postoperatively.
NCT02052414	Study of Gralise to Treat Fibromyalgia Patients	Completed	Depomed	N/A	To determine Gralise in treating fibromyalgia pain: - efficacy - safety
Trial ID	Title	Status	Sponsor	Phase	Summary