Clinical Research Trials

Gastro Florida offers clinical research trials in which volunteers participate and receive a trial treatment for a particular condition while under supervision. There are multiple advantages for participating in a clinical research trial. They include:

  • Access to the latest treatments before they are widely available
  • Therapeutic options when other methods have not worked
  • Playing an active role in your health care
  • Help others by contributing to science and research
  • Research may lead to better treatment of their condition
  • No monetary cost to the patient

 

For more information about the active trials listed below, please e-mail This email address is being protected from spambots. You need JavaScript enabled to view it. or call (727) 347-0005 and dial extension 1005.

Active Trials

Click on a condition below to see active trials

Genentech: Bergamot

GA29144: This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderate to severely active CD in participants who are refractory or intolerant to corticosteroids (CS), immunosuppressants (IS), or anti-tumor necrosis factors (anti-TNFs) or have inadequate response to anti-tumor necrosis factor (TNF-IR). Participants who enroll on the basis of refractory or intolerance to CS and/or IS may have been previously exposed to anti-TNFs or be naïve to anti-TNFs. The study period will consist of Screening Phase (up to 35 days) plus (+) 14-week Induction Phase + 52-week Maintenance Phase + 12-week Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving decrease of 70 points in Crohn's Disease Activity Index (CDAI) from baseline (CDAI-70 response) without the use of rescue therapy will continue to the Maintenance Phase.

Pfizer: Pizzicato

B7981007: The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.

Janssen: Seavue

CNTO1275CRD3007: The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.

Celgene: True North

RPC01-3201: This is a Phase 3, randomized, double-blind, placebo-controlled study to explore the effect of oral ozanimod as an induction treatment for subjects with moderately to severely active Crohn's Disease.

Shire: Carmen

SHP647-306: 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.

Takeda

Vedolizumab-4006: The purpose of this study is to determine the effect of triple combination therapy with an anti-integrin (vedolizumab intravenous [IV]), a tumor necrosis factor (TNF) antagonist (adalimumab subcutaneously [SC]), and an immunomodulator (oral methotrexate) on endoscopic remission in participants with newly-diagnosed CD stratified at higher risk for complications.

Allergan

3150-301-008: This study seeks to evaluate the safety and efficacy of Brazikumab versus placebo (Stage I) and versus an active comparator (Stage 2) in participants with moderately to severely active CD and will include assessments of clinical response as demonstrated by improvement of symptoms and colonic mucosal appearance as observed on endoscopy.

Reistone

RSJ10201: The proposed study is a randomized, double-blind, placebo-controlled, multi-center Phase II study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active Crohn's Disease. The study aims to evaluate the optimal dose of SHR0302 and time needed in inducing clinical remission in active CD. This is an 12+12 weeks study, in which participants who complete the first 12 weeks treatment phase, will have the option to enter a blinded active arms 12-week extension phase. Early withdrawn subjects during the first treatment phase cannot enter the extension phase. The total duration of the study participation, including extension and follow-up, will be approximately 26 weeks.

Ironwood

C3718-301: The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard-dose proton pump inhibitors (PPIs).

Prometheus

16HEP01: Procurement of blood samples from subjects with diagnosed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) for use in the development of a liver fibrosis test.

Tobira: Aurora

3152-301-002: The AURORA study will be conducted to confirm the efficacy and safety of Cenicriviroc (CVC) for the treatment of liver fibrosis in adult subjects with NASH.

Enata

EDP 305-201: A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis.

GlaxoSmithKline

201000: This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC). Participants will be treated with either placebo or one of the 4 dose regimens of GSK2330672 (20 milligram [mg], 90 mg or 180 mg taken once daily or 90 mg twice daily). Subjects on GSK2330672 will also receive placebo tablets to maintain blinding. The total duration of a subject's participation will be up to 45 days of screening and 24 weeks of study including follow-up.

Allergan

The present study (3151-201-008) seeks to evaluate the efficacy and safety of Brazikumab versus placebo in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy.

Eli Lilly: Lucent

I6T-MC-AMAN: The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.

Pfizer: Vibrato

B7981005: The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.

Seres

SERES-201: This is a Phase 2B randomized, double-blind, placebo-controlled, multiple dose, multicenter study designed to evaluate the efficacy, safety and microbiome alterations associated with two dose levels of SER-287, after pre-treatment with vancomycin, in adult subjects, age 18-80, with active mild-to-moderate ulcerative colitis (UC).

Shire: Figaro

SHP647-302: 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 participants with moderate to severe ulcerative colitis (UC).

AbbVie

M14-675: The objective of this study is to evaluate the efficacy and safety of Upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).

Arena

APD334-301: The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.

Sublimity

Study CYC-202 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ST-0529 in subjects with moderately to severely active UC, defined as a score of 5 to 9 on the 3-Component Adapted Mayo Score (comprised of rectal bleeding, stool frequency and endoscopy sub-scores; score range 0-9).

Reistone

RSJ10101: The proposed study is a randomized, double-blind, placebo-controlled, multicenter phase 2 study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active ulcerative colitis. The study aims to evaluate the optimal dose of SHR0302 and time needed in inducing clinical response in active ulcerative colitis patients. This is an 8+8 weeks study, in which participants who complete the first 8 weeks treatment phase, will have the option to enter a blinded active arms 8-week extension phase. Early withdrawn subjects during the first treatment phase cannot enter the extension phase. The total duration of the study participation, including extension and follow-up, will be approximately 18 weeks.

Pfizer

B7581002: The purpose of this study is to determine if PF-06687234 is effective and safe as add-on therapy to infliximab in subjects with active ulcerative colitis who are not in remission.

Vedanta

VE303-002: This study will evaluate the safety and efficacy of VE303 for participants with recurrent Clostridium difficile infection (rCDI).

Allergan

RLM-MD-01: This study will evaluate the safety and efficacy of Relamorelin compared to placebo in patients with diabetic gastroparesis. Patients will report daily severity scores of their diabetic gastroparesis symptoms.