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Clinical Research

Dr. Singaram’s Completed Major Research Projects:

  1. Immunohistochemical mapping of the neurotransmitters in the GI tract – Harvard Medical School 1988-1992; Funded by VA MERIT Award.
  2. Characterization of a Novel Achalasia model in Opossum, UW-Madison, 1994-2000; Funded by VA RAG Award and NIH-R01 grants.
  3. Alterations in neurotransmitter status and its molecular mechanisms in animal models and in humans, UW-Madison, Wisconsin, 1992-1998; Funded by UW Research Foundation, CCFA, Industrial support.
  4. Clinical study on sphincter muscle mechanisms of defecation in Humans-1993 UW-Madison; Funded by Industry support.Clinical and endoscopic study as part of multicenter evaluation of effect of NSAID on gastric mucosal integrity in short term, UW-Madison, Clinical research center, 1996; Funded by NIH as part of multicenter project.
  5. Clinical study on mechanism and blockage of visceral sensitivity using advanced anorectal manometrical procedures in humans, UW-Madison, 1994; Funded by UW Research Foundation.
  6. Clinical studies on the mechanisms of oropharyngeal disorders in elderly, UW-GRECC and VA hospitals, 1992-1996; Funded by UW-Madison GRECC.

Completed Clinical Research Projects (Last 10 Years) for Which Dr. Singaram Served as Principal Investigator:

  1. Instrument evaluation project for double pull-through capsule endoscopy, Olympus Instruments; Completed in 2011
  2. Solesta injection dose response study for Fecal Incontinence; Salix, completed in 2011;
  3. Long term non-interventional registry to assess safety and effectiveness of HUMIRA in subjects with moderately to severely active Crohn’s disease. 2009-2014.
  4. A non-interventional long-term post marketing registry of patients treated with Cimzia for Crohn’s disease. 2009-Febuary 2021.
  5. A 12 week, randomized double-blind placebo-controlled study of Asimadoline in subjects with diarrhea predominant irritable bowel syndrome. October 2012- January 2013.
  6. TEN-01-302: A 26-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C). May 2016-September 2017.
  7. Vedolizumab-4006: An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy with Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects with Crohn’s Disease Stratified at Higher Risk for Developing Complications. February 2017-October 2018.
  8. RECD3125: 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 Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease. September 2014-November 2018.
  9. RHB 105-02: A Randomized Double Blind Active Comparator Controlled Phase III Study to Assess the Safety and Efficacy of RHB-105 in the Treatment of Confirmed Helicobacter pylori (H. pylori) Infection.
  10. A Randomized, Double-blind Multidose, Placebo-controlled, Parallel Group, Multicenter Trial to Evaluate the Safety and Efficacy of IMO-9200 versus Placebo in Subjects with Active Ulcerative Colitis
  11. A Randomized, Double-blind Multidose, Placebo-controlled, Parallel Group, Multicenter Trial to Evaluate the Safety and Efficacy of IMO-9200 versus Placebo in Subjects with Active Crohn’s Disease

Ongoing Phase Clinical Research Trials for Which Dr. Singaram is Serving as Principal Investigator:

  1. Vedolizumab-4014: A Phase 4, Open-Label Study to Evaluate Vedolizumab IV Dose Optimization on Treatment Outcomes in Nonresponders With Moderately to Severely Active Ulcerative Colitis (ENTERPRET). March 2017-Current. Role: Principal Investigator
  2. LUCENT 1 Protocol I6T-MC-AMAN: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis
  3. LUCENT 2 Protocol I6T-MC-AMBG: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis
  4. LUCENT 3 Protocol I6T-MC-AMBG: A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis
  5. VIVID-1 Protocol I6T-MC-AMAM: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn’s Disease
  6. CeD-LA-3001: A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide for Relief of Persistent Symptoms in Patients with Celiac Disease on a Gluten Free Diet