Our Center for Clinical Research
Dr. Gellis is a fine, caring physician and is a great addition to your staff.
 
-- Anonymous, Patient Satisfaction Survey -- 2010

 

Past Clinical Research Studies

Over the past 15 years we have participated in the following clinical research trials. Due to ongoing confidentiality agreements, some portions of the study name have been “XXXX” out.
 
  • Multicenter Randomized, Double Blind, Placebo Controlled Evaluation of Healing and Relapse Rates Following Oral GRXXXXX in Combination with Clarithromycin Compared to GRXXXXX, Clarithromycin, and Placebo in Patient with Duodenal Ulcer
  • Multicenter Randomized, Double Blind, Placebo Controlled Evaluation of Healing and Relapse Rates Following Oral GRXXXXX in Combination with Clarithromycin Compared to GRXXXXX, Clarithromycin, and Placebo in Patient with Gastric Ulcer
  • Double Blind, Randomized, Placebo Controlled Study of The Safety and Efficacy of Three Dose Regimens of Oral XXXXX in the Treatment of Ulcerative Colitis
  • Twelve week-randomized, double blind, Placebo controlled, Multicenter Study of GRXXXXX in Female Subjects with Irritable Bowel Syndrome (IBS)
  • Intron A & Ribavirin for Treatment of Patients with Interferon Refractory or Interferon-Relapsed Chronic Hepatitis C
  • Intron A & Ribavirin for Treatment of Patients with Chronic Hepatitis C, not previously treated with Intron A or Ribavirin
  • A Twelve-Week Randomized, Double-Blind, Placebo-Controlled, Multi-center, Study of XXXXXX In Female Subjects With Irritable Bowel Syndrome (IBS)
  • A 24 Week Randomized, Open label Study of Health Care Resource Use, Quality of Life and productivity with Alosetron 1mg Twice Daily, versus Traditional Therapy in Females with Non-Constipated Irritable Bowel Syndrome
  • Double Blind, Placebo-Controlled, Randomized, Multicenter Study to Investigate the Efficacy and Safety of Cilansetron in Non-Constipated Patients with Established Irritable Bowel Syndrome, ADDENDUM 1: An Open Labeled, Multi-Center Study to Investigate the Long Term Safety of Cilansetron in Non-Constipated Patients with Established Irritable Bowel Syndrome
  • Phase III, prospective, randomized, double-blind, 3-arm, multi-center study to compare the efficacy and safety of Celecoxib 200 mg bid, and Celecoxib 400mg bid, versus placebo in reducing the occurrence of new adenomatous polyps in the colo-rectum at Year 1, and Year 3 after endoscopic polypectomy. NCI Protocol No N01-CN-95015 G.D. Searle Protocol NO IQ4-99-02-005, Prevention of Sporadic Colorectal Adenomas with Celecoxib
  • A Clinical Study to Determine the Safety of Rxxxxxxxx in Subjects with Crohn’s Disease
  • TREAT Registry for Crohn’s patients
  • A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Investigate the Safety and Efficacy of 2 mg Gxxxxxxxxx over 12 Weeks Followed by a 4-week Re-randomized Treatment Period in Diarrhea-Predominant Irritable Bowel Syndrome Subjects
  • A Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Efficacy, Safety and Tolerability of XXX 2 mg BID and 6 mg BID Given Orally vs. Placebo in Patients with Chronic Constipation
  • Multi-Center, Open-Label, Safety Study of Oral XXX for the Treatment of Occasional Constipation
  • A Phase III 48-Week Open-Label Safety Study of Oral XX-XXXX for the Treatment of Occasional Constipation
  • A Phase III, multi-national, multi-centre, double-blind, placebo-controlled, parallel group, 26 week study to assess the safety and efficacy of the humanised anti-TN PEG conjugate, XXXXXX, 400 mg, (dosed at Weeks 0, 2, 4 then 4-weekly to Week 24), in the treatment of patients with active Crohn’s disease
  • A Phase III, multi-national, multi-centre, open label, 52 week safety study to assess the safety of chronic therapy with the humanised anti-TNF PEG conjugate XXXXXX 400 mg sc, (dosed 4-weekly to Week 48), in the treatment of patients with active Crohn’s disease who have previously completed studies XXXX-031 or XXXX-032
  • A Phase III, multi-national, multi-centre, open label, 52 week safety study to assess the safety of re-exposure after a variable interval and subsequent chronic therapy with the humanised anti-TNF PEG conjugate XXXXXX 400 mg sc (Dosed at weeks 0, 2 and 4 then 4-weekly to Week 48), in the treatment of patients with active Crohn’s disease who have previously been withdrawn from study XXXXXX-031 or XXXXXX-032 due to an exacerbation of Crohn’s disease
  • Irritable Bowel Syndrome Longitudinal Outcomes Study (ILOS)
  • A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody XXXXXXXX for the Induction of Clinical Remission in Subjects with Moderate to Severe Crohn’s Disease who Have Lost Response or are Intolerant to Infliximab
  • A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody XXXXX to Evaluate the Long-term Safety and Tolerability of Repeated Administration of XXXXXX in Subjects with Crohn’s Disease
  • A Phase 3 Study to Evaluate the Efficacy and Safety of XXX-XXX (60 mg QD and 90 mg QD) Compared to Placebo on Symptom Relief in Subjects with Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD)
  • A Phase 3 Study to Evaluate the Efficacy and Safety of XXX-XXXXX (60 mg QD and 90 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on healing of Erosive Esophagitis
  • A Phase 3 Study to Evaluate the Safety and Efficacy of XXX-XXXX (60 mg QD and 90 mg QD) Compared to Placebo in Maintenance of Healing in Subjects with Healed Erosive Esophagitis
  • A Phase 3, Open-Label Study to Assess the Long-Term Safety of XXX-XXXX (60 mg QD and 90 mg QD)
  • Multi-center, Randomized, Double-blind, Placebo-Controlled Trial of XXXX Tablets in the Treatment of Mild to Moderate Active Crohn’s Disease in Adults
  • Multi-center, Randomized, Blinded, Placebo Controlled, Cross-Over Study to Investigate the Safety and Tolerability of Intravenous XXX-XX in Patients with Iron Deficiency Anemia
  • A 12-Week, Multi-center, Double-Blind, Randomized Efficacy and Safety Study of XXXXXXXXXXXX for the Treatment of Constipation-Predominant Irritable Bowel Syndrome
  • An Open-Label Safety Study of XXXXXXXX for Constipation-Predominant Irritable Bowel Syndrome
  • A Multi-center, Open-Label Treatment Protocol of the Human Anti-TNF Monoclonal Antibody XXXXXXXXX in Patients with Moderate to Severe Crohn’s Disease with Previous Exposure to Infliximab
  • Qualitative Study of Patients with Gastroesophageal Reflux Disease
  • A Multicenter, Randomized, Double-blind, Placebo-controlled study of the Human Anti-TNF Monoclonal Antibody XXXXXXXXXX for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis
  • A phase IV multi-center, open-label study to assess clinical recurrence related to compliance with treatment with XXX mesalamine 2.4g/day given once daily for the maintenance of quiescent ulcerative colitis.
  • A 5 year registry study of XXXXX in subjects with moderately to severely active Crohn’s disease
  • A phase 2B, multi-center, randomized, double-blind, placebo controlled, dose ranging study comparing the efficacy, safety, and pharmacokinetics of intravenous infusions of XXX-XXX vs. placebo in subjects with moderately to severely active Crohn’s disease.
For more information, please contact our research coordinator by calling 216-593-7461, or sending an email to research@gastro-associates.com.