Previously completed studies including Phase II, Phase III and post marketing Safety Registries in such disease states as Anemia, Crohn’s disease, Ulcerative colitis, Hepatitis C, Chronic constipation, Irritable Bowel Syndrome, and Opioid induced constipation, Barrett’s Esophagus, Primary Biliary Cirrhosis, Anal Fissures, Proctitis, and Gastroparesis.

Participation in previous clinical trials with the following Sponsors and CRO’s

  • Abbott Laboratories
  • Axcan Pharmaceuticals
  • Barrx Medical
  • Centocor
  • Esai
  • Genomics
  • Icon
  • INC
  • Kendle
  • Janssen Research
  • Johnson & Johnson
  • National Institute of Health
  • Parexel International
  • Pfizer
  • PRA, International
  • Proctor and Gamble
  • Prometheus Therapeutics and Diagnostics
  • Roche
  • Salix
  • Schwarz Biosciences
  • Sucampo
  • UCB Biosciences
  • University of Pennsylvania
Current Clinical Trials

ANEMIA

Luitpold Pharmaceuticals, Inc. 1VIT13035

A Multi-center, Randomized, Open-label, Controlled Study to Investigate the Treatment Response of Intravenous Injectafer (Ferric Carboxymaltose) vs. Oral Iron to Baseline Hepcidin Levels in Patients with Iron deficiency Anemia (IDA) secondary to Inflammatory Bowel Disease.

CROHN’S DISEASE

Abbvie Celest M13-740

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.

Bioserve 9000

Collection of biologic specimens for a genomic repository. This study is to enroll subjects with Moderate to severely active Crohn’s OR Ulcerative Colitis. Must be collected within one week after colonoscopy. Subjects will have local labs for CBC, CRP, ESR, and IL-6 as well as one tube for bio-banking.

Gilead GS-US-395-1663

A Phase 2, double-blind, randomized, placebo-controlled, multicenter study evaluating the safety and efficacy of GS-5745 in subjects with moderately to severely active Crohn’s Disease.

Tsumara

A Multi-center, Randomized, Double-Blind, Placebo-controlled Study of Daikenchuto (TU-100) in Subjects with Moderate Crohn’s Disease

UNITI2-Centocor

A Phase III, Randomized, Double-Blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Ustekinumab (Stelara) Induction therapy in Subjects with Moderately to Severely Active Crohn’s Disease

IMUNITI-Centocor

A Phase III, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease

PREVENT-REMICADECRD3001

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 Risk of Recurrence

Prometheus

A study to assess the association of clinical outcome with serum drug concentration levels and anti-drug antibody in moderately to severely active Cohn’ disease patients treated with Adalimumab. Eligible patients are adults 18 years or older with a diagnosis of moderately to severely active Crohn’s disease who are initiating treatment with Adalimumab.

CLOSTRIDIUM DIFFICLE INFECTION

Seres Ecospore

A randomized, double-blind, placebo-controlled, parallel-group study of SER-109 to prevent recurrent clostridium difficile infection.

PRIMARY BILIARY CIRRHOSIS

PURIFI-Centocor

A Phase II, Multi-center, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Ustekinumab (Stellara) in Subjects with Primary Biliary Cirrhosis Who had an Inadequate Response to Ursodeoxycholic Acid (UDCA)

IRRITABLE BOWEL SYNDROME

Salix RFIB3053

A Study to Assess Repeat Treatment Efficacy and Safety of Rifaxamin 550 mg TID in Subjects with Irritable Bowel Syndrome with diarrhea (IBS-d)

Furiex 27018966IBS3001

A Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea Predominant Irritable Bowel Syndrome.

ULCERATIVE COLITIS

Celgene- CC-10004-UC-001

A phase 2, randomized, placebo controlled, multicenter study to investigate the efficacy and safety of apremilast (CC-10004) for the treatment of subjects with active Ulcerative Colitis.