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Clinical Studies
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Closed for Enrollment
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A Phase 2 Dose Ranging, Randomized, Double Blind, and Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of EDP-305 in Subjects with Nonalcoholic Steatohepatitis (NASH) (NASH)
Scottsdale/Phoenix, Ariz.,
La Crosse, Wis.
The purpose of this double-blind study is to obtain the most unbiased assessment of clinical safety and efficacy with the doses of EDP-305 being studied.
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A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) (AIDA)
La Crosse, Wis.
The purpose of this study is to evaluate the safety and tolerability of long-term treatment with SHP647 in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD).
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A Phase 3 Randomized, Double-blind, Placebo Controlled, Parallel Group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) (FIGARO UC 303)
La Crosse, Wis.
The purpose of this study is to evaluate the efficacy of SHP647 as maintenance therapy in participants with moderate to severe ulcerative colitis (UC) who achieved clinical response in induction studies.
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A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel Group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 302)
La Crosse, Wis.
The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).
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A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 306) (SHP647)
La Crosse, Wis.
The purpose of this study is to evaluate the efficacy and safety of SHP647 in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.
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A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome
La Crosse, Wis.
This study is being done to see if Lyrica helps people with irritable bowel syndrome. Lyrica is the trade name for pregabalin, which was first approved by the FDA in June 2005 and has been available through prescription since fall 2005, and is marketed by Pfizer. Lyrica is known to have clinical efficacy treating pain disorders including irritable bowel syndrome-related conditions such as fibromyalgia.
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CARMEN CD 307: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects with Moderate to Severe Crohn's Disease (SHP647)
La Crosse, Wis.
The purpose of this study is to evaluate the efficacy of SHP647 as maintenance therapy in subjects with moderate-to-severe Crohn's disease.
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Correlation of Infliximab Levels with Outcomes in Ulcerative Colitis
Rochester, Minn.,
La Crosse, Wis.
The purpose of this study is to assess if infliximab drug levels in patients who have Ulcerative Colitis predict the risk of needing a colectomy. Additionally, the investigators will estimate an optimal day 4 infliximab level based on the study results.
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Recent Elevated Glucose And Recent Diabetes (REGARD) Cohort (REGARD)
La Crosse, Wis.,
Rochester, Minn.,
Eau Claire, Wis.
The purpose of this study is to establish a biobank of blood samples to study the relationship between diabetes mellitus and other pancreatic conditions.
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Use of Medication Therapy Management to Optimize Care Through Effective Resource Management in Inflammatory Bowel Disease
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.,
Eau Claire, Wis.,
Mankato, Minn.,
La Crosse, Wis.
The management of Inflammatory Bowel Disease (IBD) is complex and time consuming. While Current Procedural Terminology for MTM services are available they are under-utilized given the time constraints placed on practitioners trying to address multiple health care issues during a single visit. There are companies that specialize in patient pharmacy services to improve health care outcomes. Our aim is to utilize these services in a small number of IBD patients to assess effectiveness of such services within a tertiary care practice.
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