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Clinical Trials and Disease Education

As an IBD (Inflammatory Bowel Disease) Center of Excellence, we have made a commitment to our patients to participate in the Advancement of Science, with goals to contribute to & improve the global understanding & treatment of IBD.  We are proud to offer all IBD patients access to both conventional & novel therapies through a variety of Clinical Trails, ranging from Gut-Specific Antibiotics to Stem-Cell Infusions.  We have been involved in the Research & Development of IBD medications since 1997, collaborating with leaders in medical & pharmaceutical science and have participated in the development of many currently available therapies such as Remicade®, Humira®, Cimzia®, Stelara® and Simponi®.

We invite you to view the Clinical Trials in which we are currently enrolling. Qualified participants will receive Study Medications and Study-related Evaluations at NO Cost. Some weblinks are provided for more detailed information.

ENROLLING TRIALS

Crohn’s Disease

Ulcerative Colitis

FILLED TRIALS

Crohn’s Disease

Ulcerative Colitis

Inflammatory Bowel Disease

Irritable Bowel Syndrome

Ulcerative Proctitis or Proctosigmoiditis

Please contact our Clinical Coordinator, Kara Fitch, RN or Sally Hewit, RN or Renee DePanicis, RN, if you have any questions at [407] 628-8121 or [877] 4-GI-Health.

 

ENROLLING TRIALS


Crohn’s Disease

APOLLO

ENROLLING
ADoes Clinical Response Correlate with Serum Certolizumab Levels? A Prospective Open-label Trial of Adult Patients with Active Crohn’s Disease. IRB Approved: 10/15/2015. (NCT02597829)

BERGAMOT (GA29144)

ENROLLING
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction and Maintenance Treatment for Patients with Moderately to Severely Active Crohn’s Disease. IRB Approved: 06/03/2015. (NCT02394028)

CELESTE (M13-740)

ENROLLING
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn’s Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy. (NCT02365649)

JUNIPER (GA29145)

ENROLLING
An Open-Label Extension and Safety Monitoring Study of Patients with Moderately to Severely Active Crohn’s Disease Previously Enrolled in the Etrolizumab Phase III. IRB Approved: 07/30/2015. (NCT02403323)

LUX (D5170C00002)

ENROLLING
A Phase 2b Double-blind, Multi-dose, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy. (NCT02574637)

PASS (MLN-0002_401) (CD)

ENROLLING
Entyvio (Vedolizumab) long-term safety study: An International Observational Prospective Cohort Study Comparing Vedolizumab to Other Biologic Agents in Patients with Ulcerative Colitis or Crohn’s Disease. IRB Approved: 02/17/2016. (NCT02674308)

Protocol 603

ENROLLING
A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Prochymal™ (ex vivo cultured adult human mesenchymal stem cells) Intravenous Infusion for the Induction of Remission in Subjects Experiencing Treatment-Refractory Moderate-to-Severe Crohn’s Disease. IRB Approved: 10/04/2010. (NCT00482092)

Protocol 611

ENROLLING
A Multicenter, Open-label Study to Evaluate the Safety of Prochymal® (remestemcel-L) Intravenous Infusion in Subjects Who Have Received Previous Remestemcel-L Induction Treatment for Treatment-refractory Moderate-to-Severe Crohn’s Disease. IRB Approved: 11/03/2011. (NCT01233960)

RECD3125

ENROLLING
A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease. (NCT02240121)

SECURE (C87075)

ENROLLING
A Non-Interventional, Long-term, Post-marketing Reigstry of Patients Treated with Certolizumab Pegol (Cimzia®) for Crohn’s Disease. IRB Approved: 01/23/2009. (NCT00844285)

SERENE CD (M14-115)

ENROLLING
A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohn’s Disease and Evidence of Mucosal Ulceration. (NCT02065570)

SERENE CD (M14-347)

ENROLLING
A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn’s Disease. (NCT02185014)

VERSIFY (MLN0002-3028)

ENROLLING
An Open-label, Phase 3b Study to Assess Mucosal Healing in Subjects with Moderately to Severely Active Crohn’s Disease Treated with Vedolizumab IV. IRB Approved: 03/22/2016. (NCT02425111)

VISIBLE CD (MLN0002SC-3031)

ENROLLING
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease who Achieved Clinical Response Following Open-label Vedolizumab Intravenous Therapy. IRB Approved: 04/01/2016. (NCT02611817)

VISIBLE CD (MLN0002SC-3030)

ENROLLING
A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease. IRB Approved: 04/01/2016. (NCT02620046)
 

Ulcerative Colitis

COTTONWOOD (GA28951)

ENROLLING
An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase III Studies. (NCT02118584)

HICKORY (GA28950)

ENROLLING
A Phase III, Double Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab during Induction and Maintenance in Patients with Moderate to Severe Active Ulcerative Colitis Who are Refractory to or Intolerant of TNF Inhibitors. (NCT02100696)

LAUREL (GA29102)

ENROLLING
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Maintenance of Remission) and Safety of Etrolizumab Compared with Placebo in Patients with Moderate to Severe Active Ulcerative Colitis Who are Naïve to TNF Inhibitors. (NCT02165215)

LEGACY (P11-282)

ENROLLING
A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis. (NCT01848561)

MEER (000174)

ENROLLING
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis. IRB Approved: 01/19/2016. (NCT02522767)

MEER (000175)

ENROLLING
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis. IRB Approved: 01/19/2016. (NCT02522780)

PASS (MLN-0002_401) (UC)

ENROLLING
Entyvio (Vedolizumab) long-term safety study: An International Observational Prospective Cohort Study Comparing Vedolizumab to Other Biologic Agents in Patients with Ulcerative Colitis or Crohn’s Disease. IRB Approved: 02/17/2016. (NCT02674308)

Sanofi LTS12593 (FUSCIA-OL)

ENROLLING
A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis. (NCT01861249)

SERENE UC (M14-033)

ENROLLING
A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis. (NCT02065622)

TRIUMPH (GS-US-326-1100)

ENROLLING
A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis. IRB Approved: 10/16/2015. (NCT02520284)

UNIFI (CNTO1275UCO3001)

ENROLLING
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis. IRB Approved: 09/29/2015. (NCT02407236)

VARSITY (MLN0002-3026)

ENROLLING
A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects with Ulcerative Colitis. IRB Approved: 10/09/2015. (NCT02497469)

VISIBLE UC (MLN0002SC-3027)

ENROLLING
A Phase 3 Randomized, Double-blind, Placebo-controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-label Vedolizumab Intravenous Therapy. IRB Approved: 04/01/2016. (NCT02611830)

VISIBLE UC (MLN0002SC-3030)

ENROLLING
A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease. IRB Approved: 04/01/2016. (NCT02620046)
 

FILLED TRIALS


Crohn’s Disease

C13008 (GEMINI) (CD)

FILLED
A Phase 3 Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease. IRB Approved: 12/03/2008. (NCT00790933)

CD-IA-MEDI2070-1147

FILLED
A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy. (NCT01714726)

Cimzia IIS

FILLED
An Open-label, Investigator Initiated, Single Site Study of Mucosal Healing in Patients with Small Bowel Crohn’s Disease Treated with Certolizumab Pegol (Cimzia) Assessed by Wireless Capsule Endoscopy. IRB Approved: 12/24/2009. (NCT01053559)

IM129008

FILLED
A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn’s Disease. IRB Approved: 01/10/2012. (NCT01466374)

IMUNITI (CNTO1275CRD3003)

FILLED
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Effficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease. IRB Approved: 05/16/2011. (NCT01369355)

MA-209

FILLED
Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn’s Disease (CD) Subjects Receiving an Immunomodulator (IMM) and/or a Biological Treatment. (NCT01942720)

MAP US (RHB-104-01)

FILLED
A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease. (NCT01951326)

PREVENT (REMICADECRD3001)

FILLED
A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Comparing Remicade® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who are at an Increased Risk of Occurrence. IRB Approved: 06/29/2010. (NCT01190839)

Protocol C87088

FILLED
A Phase IIIb, Multinational, Open-label, Follow-on Trial to C87085 Designed to Assess the Long-term Safety of certolizumab pegol, a pegylated Fab’ Fragment of a Humanized anti-TNF-alpha monoclonal antibody, Administered at Weeks 0, 2, and 4, and then every 4 Weeks Thereafter, in Subjects with Moderately to Severe Active Crohn’s Disease Who Have Participated in Study C87085. IRB Approved: 12/12/2007. (NCT00552344)

Protocol CD0006

FILLED
Validation of Clinical and Demographic Predictors of Maintaining Remission in Crohn’s Disease Patients Prescribed Certolizumab Pegol in Community Practice.

Protocol GED-0301-CD-001

FILLED
A Randomized, Double-Blind, Multicenter Study to Explore the Effect of GED-0301 on Endoscopic and Clinical Outcomes in Subjects with Active Crohn’s Disease. IRB Approved: 10/22/2015. (NCT02367183)

Protocol TU100P2T2

FILLED
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Daikenchuto (TU-100) in Subjects with Moderate Crohn’s Disease. IRB Approved: 08/23/2011. (NCT01388933)

PYRAMID (P06-134)

FILLED
A 5-Year Registry Study of Humira® (Adalimumab) in Subjects with Moderately to Severely Active Crohn’s Disease. IRB Approved: 08/15/2007. (NCT00524537)

TRUST-1 (CNDO 201-003)

FILLED
A Phase II Study to Evaluate the Efficacy and Safety of 12 Weeks of Treatment with Oral CNDO 201 Trichuris Suis Ova Suspension (TSO) as Compared to Placebo, Followed by a 12 Week Open-label Treatment Period in Patients with Moderately to Severely Active Crohn’s Disease. IRB Approved: 06/29/2012. (NCT01576471)

UNITI 1 (CNTO1275CRD3001)

FILLED
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy. IRB Approved: 05/16/2011. (NCT01369329)

UNITI 2 (CNTO1275CRD3002)

FILLED
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease. IRB Approved: 05/16/2011. (NCT01369342)
 

Ulcerative Colitis

C13008 (GEMINI) (UC)

FILLED
A Phase 3 Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease. IRB Approved: 12/03/2008. (NCT00790933)

CONTRIBUTE (C2011-0401)

FILLED
A Phase IIIb Randomized, double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen. IRB Approved: 11/23/2011. (NCT01532648)

FUSCIA (SAR339658 / ACT12688)

FILLED
A Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study Evaluating Efficacy and Safety of SAR339658 in Patients with Active Moderate to Severe Ulcerative Colitis. IRB Approved: 05/10/2012. (NCT01659138)

MERIT-UC

FILLED
A Phase II Randomized, Double-blind, Prospective Trial Investigating the Efficacy of Methotrexate in Induction and Maintenance of Steroid Free Remission in Ulcerative Colitis. IRB Approved: 01/11/2012. (NCT01393405)

OCTAVE Induction 1

FILLED
A Phase 3 Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Oral CP-690,550 as an Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis. IRB Approved: 02/21/2012. (NCT01465763)

OCTAVE Open

FILLED
A Phase 3 Multicentre, Open-label Study of Oral CP-690,550 in Subjects with Moderate to Severe Ulcerative Colitis. IRB Approved: 02/21/2012. (NCT01470612)

OCTAVE Sustain

FILLED
A Phase 3 Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Oral CP-690,550 as a Maintenance Therapy in subjects with Ulcerative Colitis. IRB Approved: 02/21/2012. (NCT01458574)

PROgECT (CNTO148UCO2001)

FILLED
A Phase 2a Open-label study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis. (NCT01988961)

PURSUIT (C0524T18)

FILLED
A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind, Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously in Subjects with Moderately to Severely Active Ulcerative Colitis. IRB Approved: 05/14/2007. (NCT00488631)

TURANDOT (A7281009)

FILLED
A Double-blind, Double-dummy, Randomized, Placebo-controlled, Parallel,Dose-ranging Study to Evaluate the Efficacy and Safety of PF-00547659 in Subjects with Moderate to Severe Ulcerative Colitis. (NCT01620255)

TURANDOT II (A7281010)

FILLED
A Multicenter, Open-label, Extension Study to Assess Long-term Safety of PF-00547659 in Subjects with Ulcerative Colitis. (NCT01771809)

ZA 201

FILLED
A Phase II Double-Blind, Randomized, Comparator-Controlled Study of the Safety and Efficacy of Zoenasa™ Rectal Gel (mesalamine plus N-acetylcysteine) in Subjects with Left-Sided Ulcerative Colitis. IRB Approved: 11/02/2012. (NCT01586533)
 

Inflammatory Bowel Disease

RP1208

FILLED
A Randomized Evaluation of Health Costs and Resource Utilization Comparing Testing-Based Therapy to Empiric Dose Intensification for the Management of Inflammatory Bowel Disease. (NCT01960426)
 

Irritable Bowel Syndrome

RFIB 3053

FILLED
A Phase 3 Study to Assess Repeat Treatment Efficacy and Safety of Rifaximin 550 mg TID in Subjects with Irritable Bowel Syndrome with Diarrhea (IBS-d). IRB Approved: 04/02/2012. (NCT01543178)
 

Ulcerative Proctitis or Proctosigmoiditis

BFPS 3073

FILLED
A Phase 3, Open-label, Multicenter Study to Assess the Safety and Tolerability of Budesonide Foam In Subjects with Active Ulcerative Proctitis or Proctosigmoiditis. IRB Approved: 05/13/2011. (NCT01349673)

BUCF 3002

FILLED
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Budesonide Foam (2mg/25mL BID for 2 weeks, followed by 2mg/25mL QD for 4 Weeks) Versus Placebo in Subjects with Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis. IRB Approved: 10/21/2009. (NCT01349673)
 
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