Clinical Trials
CROHN’S DISEASE
A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study To Evaluate The Efficacy And Safety Of PF-04236921 In Subjects With Crohn’s Disease Who Are Anti-Tnf Inadequate Responders (Andante)
PI: Gerald Dryden, M.D. 502-852-0156
Research Coordinator: Susie Mann, L.P.N. 502-852-1919 sbmann01@gwise.louisville.edu
Protocol Number TU100P2T2 / A Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects with Moderate Crohn’s Disease
PI: Gerald Dryden, M.D. 502-852-0156
Research Coordinator: Susie Mann, L.P.N. 502-852-1919 sbmann01@gwise.louisville.edu
A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease (IM133005)
PI: Gerald Dryden, M.D. 502-852-0156
Research Coordinator: Mechelle Stoner, RN 502-852-7407
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase II Study To Evaluate The Efficacy And Safety Of 12 Weeks Of Treatment With Two Different Doses Of Oral CNDO 201 Trichuris Suis Ova Suspension (TSO) As Compared To Placebo, Followed By A 12 Week Open-Label Treatment Period With TSO, In Patients With Moderately To Severely Active Crohn’s Disease
PI: Gerald Dryden, M.D. 502-852-0156
Research Coordinator: Mechelle Stoner, RN 502-852-7407
ULCERATIVE COLITIS
Randomized, double blind, prospective trial investigating the efficacy of Methotrexate in induction and maintenance of steroid free remission in ulcerative colitis (MEthotrexate Response In Treatment of UC - Merit-UC)
PI: Gerald Dryden, M.D. 502-852-0156
Research Coordinator: Lisa Hatter, R.N. 502-852-3383 lisa.hatter@louisville.edu
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of Multistem (PF-05285401) in Subjects with Moderate to Severe Ulcerative Colitis.
PI: Gerald Dryden, M.D. 502-852-0156
Research Coordinator: Susie Mann, L.P.N. 502-852-1919 sbmann01@gwise.louisville.edu
IBS
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome
PI: Gerald Dryden, M.D. 502-852-0156
Research Coordinator: Mechelle Stoner, RN 502-852-7407
C. DIFFICILE INFECTION
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Effectiveness of a Single Infusion of MK-3415A (Human Monoclonal Antibody to Clostridium difficile toxin A and toxin B) in Patients Receiving Antibiotic Therapy for C. difficile Infection (CDI) (MODIFY II)
PI: Gerald Dryden, M.D. 502-852-0156
Research Coordinator: Susie Mann, L.P.N. 502-852-1919 sbmann01@gwise.louisville.edu
HEPATITIS C
A Phase 3, Safety and Efficacy Study of Boceprevir/Peginterferon Alfa-2a/ribavirin in Chronic HCV Genotype 1 IL28B CC Subjects
PI: Matt Cave, MD
Research Coordinator: Lisa Hatter, RN 502-852-3383 lisa.hatter@louisville.edu
A Randomized, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly with Peginterferon alfa-2b and Ribavirin in Treatment-Naive Patients with Chronic Genotype 1 Hepatitis C Virus Infection (CIRRHOTIC COHORT)
PI: Matt Cave, MD
Research Coordinator: Lisa Hatter, RN 502-852-3383 lisa.hatter@louisville.edu
GASTROPARESIS
GpR 2: Continuation of the NIDDK Gastroparesis Registry for the Characterization and Clinical Course of Gastroparesis Patients
PI: Thomas Abell, MD
Research Coordinator: Karen Beatty, RN 540-1428 karen.beatty@louisville.edu
