| TITLE |
BODY LOCATION |
DISEASE TYPE |
COORDINATOR |
| A Phase 2b, Multicenter, Randomized, Double-blind, Placebo–controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Previously Treated with TNF Antagonist Therapy (CERTIFI)
|
Large Intestine,Other,
|
Crohns Disease
|
|
|
|
| A Phase III Study to Demonstrate the Efficacy and Safety of RG1068 (Synthetic Human Secretin)-Enhanced Magnetic Resonance Cholangiopancreatography (MRCP) in the Evaluation of Subjects with a History of Acute or Acute Recurrent Pancreatitis
|
Pancreas,
|
Pancreatitis
|
|
|
|
| A Study of the Safety and Effectiveness of CNTO 148 (Golimumab) in Patients With Moderately to Severely Active Ulcerative Colitis--Rollover Study
|
Large Intestine,
|
Ulcerative Colitis
|
Rebekah Whichard,
|
| The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis.
|
| A Study of The Safety and Effictiveness of CNTO 148 (Golimumab) in Patients with Moderately to Severely Active Ulcerative Colitis
|
Large Intestine,
|
Ulcerative Colitis
|
Rebekah Whichard,
|
| The purpose of this clinical study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with Ulcerative Colitis.
|
| A Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease (GEMINI II)
|
Large Intestine,
|
Crohns Disease
|
Rebekah Whichard,
|
| This multicenter, phase 3, randomized, blinded, placebo-controlled study in patients with moderately to severely active CD comprises two phases:
The Induction Phase, designed to establish the efficacy and safety of vedolizumab (MLN0002) for the induction of clinical response and remission; and the Maintenance Phase, designed to establish the efficacy and safety of vedolizumab(MLN0002) for the maintenance of clinical response and remission.
|
| A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients With Moderate to Severe Crohn's Disease
|
Large Intestine,
|
Crohns Disease
|
Rebekah Whichard,
|
| This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's Disease. The study hypothesis is that at least one of the dose levels to be tested will be more effective than placebo (inactive drug).
|
| An Open-Label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease (GEMINI III)
|
Large Intestine,
|
Crohns Disease
|
Rebekah Whichard,
|
| This multicenter, 2-year open-label study will collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.
|
| Cimzia Registry
|
Large Intestine,Other,
|
Crohns Disease
|
|
|
|
| Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction) (SOD)
|
Large Intestine,
|
S.O.D.
|
Rebekah Whichard,
|
| This is an open-label single center study of duloxetine in patients with SOD who have failed to respond to the standard treatments.
This protocol is designed to explore the tolerability and efficacy of Duloxetine in the management of patients with known or suspected Sphincter of Oddi dysfunction (SOD).
|
| Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction (EPISOD)
|
|
S.O.D.
|
Rebekah Whichard,
|
| SOD is a disorder that involves the circular muscle that surrounds the drainage hole through which bile and pancreatic juices flow from the liver and pancreas into the duodenum (small intestine). Some patients who have had their gall bladders removed (cholecystectomy) develop increased pressure in the sphincter muscle. This causes back up of bile and/or pancreatic juices, which results in attacks of abdominal pain.
ERCP (Endoscopic retrograde cholangio-pancreatography) is a standard (non-research) procedure commonly used to diagnose problems in the liver, gallbladder, bile ducts, and pancreas including SOD.
During ERCP, the doctor can also measure the pressure (squeeze) of the sphincter muscle. This is called sphincter of Oddi manometry (SOM). Patients with abnormal SOM pressure results are usually treated at the same time by cutting the sphincter muscle (sphincterotomy), so that it cannot go into spasm, in the hope of preventing further attacks of pain. As part of the procedure, a small plastic drainage tube (stent) is usually placed (temporarily) to improve drainage and prevent complications.
The main purpose of the EPISOD trial is to study whether sphincterotomy is effective and how well patients respond. Although ERCP, SOM, and sphincterotomy are all standard clinical procedures routinely performed in patients with SOD, there is no clear scientific data showing the effectiveness of sphincterotomy (how well it works in particular patients) or whether the pressure measurements (SOM) can predict how well patients will respond to the sphincterotomy.
|