We are currently enrolling for the following exciting research trials:

• Crohn's Disease

The OPERA research study is designed to determine if an investigational medicine safely and effectively treats subjects with Crohn’s disease who are anti-TNF inadequate responders.

You may be eligible for the OPERA research study if you:
Are between 18 to 75 years old 
Have active Crohn’s disease 
Have failed to respond to anti-TNF treatment (e.g., Remicade®, Humira®, Cimzia®)
Have failed or are intolerant to immunosuppressant’s (e.g., methotrexate, azathioprine, 6-mercaptopurine)

Design

Three doses (22.5, 75 and 225 mg) of the study drug versus placebo (in a 1:1:1:1 ratio) will be investigated. Study participants will be randomly assigned to 1 of 4 treatment groups for the 12 week induction period. Subjects who complete the 12 week induction period will either enter the open label extension study (A7281007) or will enter the 2 year follow up period for this study. Subjects will be asked to visit Gastroenterology of the Rockies approximately 14 to 20 times..

For more information about this study, please contact Patricia Townsend directly at (720) 238-4310 or email at Patricia.Townsend@gastrorockies.com

Subject Compensation will be provided

• Irritable Bowel Syndrome

We are actively recruiting for a Prospective, Open Label, and Observational Study Evaluating LOTRONEX Use in Clinical Practice in Women with Severe Diarrhea-Predominant Irritable Bowel Syndrome. The Primary Objective will be on symptom relief, specifically, improvement in bowel habits and IBS pain

Primary Endpoints:

Change in Baseline in Stool Consistency
Change in Baseline in IBS Pain Intensity
Quality of Life
Stool Frequency
Change in Proportion of Days with Fecal Urgency

Study procedure

• Study Visits will consist of 4 Visits (Screening, Baseline-Day 1 of Prescribed Medication, Visit 3-4 weeks and Visit 4-Week 12)

• Subjects will be initially prescribed at Screening, but not to start until Baseline a Dose of Lotronex at 0.5 mg twice a day. Dose may be increased to 1 mg after 4 weeks (Visit3) if starting dose is well tolerated but does not adequately control IBS symptoms.

Inclusion/Exclusion

Women between 18 and 65 years old
Have experienced chronic IBS symptoms lasting 6 months or longer
Have failed to respond adequately to other IBS therapy
Either is not treated with or has been on a stable treatment regimen with any of the following medications for 1 month prior to Day 1 (first dose of Lotronex

a. Hormone Replacement Therapy
b. Oral contraceptives
c. Lipid Lowering agents
d. Thyroid replacement Therapy

For more information about this study, please contact Patricia Townsend directly at (720) 238-4310 or email at Patricia.Townsend@gastrorockies.com

Subject Compensation will be provided

• Ulcerative Colitis

Multistem Cell Study

We are actively recruiting for a MultiStem Cell Study which uses cell therapy as a medicinal product that is being developed for the treatment of Ulcerative Colitis in patients with moderate to severe Ulcerative Colitis. This study will assess safety, tolerability and preliminary efficacy/pharmacodynamics of the proposed doses.

Inclusion/Exclusion

a. Males and females with a documented diagnosis (endoscopic or radiographic) of UC 6 months prior to screening.

b. Active moderate-to-severe UC defined as Mayo score of 6 and <11.

c. Modified Baron endoscopic score of 2 determined within 7 days of first dosing for Cohort 3 (flexible sigmoidoscopy unless surveillance colonoscopy clinically indicated).

d. Subjects must have failed or be intolerant (as determined by the investigator) of at least one of the following treatments for UC: Oral corticosteroids, azathioprine or 6-Mercaptopurine (6-MP), or anti- tumor necrosis factor (TNF) therapy, e.g., infliximab or adalimumab

NOTE: Excluded medications include anti-TNF therapies used within 8 weeks of Day 1study visit or cyclosporine, mycophenolate, or tacrolimus used within 4 weeks of Day 1 Study visit as described in the exclusion criteria.

For more information about the MultiStem study, please contact Patricia Townsend directly at (720)238-4310 or email at Patricia.Townsend@gastrorockies.com

Subject Compensation will be provided

• Clostridium Difficile

A Randomized, Double-Blinded Study of CB-183,315 in Patients with Clostridium Difficile Associated Diarrhea (CDAD)

Primary Objectives: • To demonstrate the non-inferiority of CB-183,315 versus oral Vancomycin in Adult subjects with CDAD based on the difference in clinical response rates at end-of-therapy.

Inclusion Criteria:

To be eligible for enrollment, a subject must meet all of the following criteria prior to any Study related procedures:

1. Informed Consent obtained and signed;
2. Age ≥18 and <90 years;
3. Has diarrhea with a minimum of three unformed bowel movements or >200 mL Volume of stool for subjects with a collection device (e.g. rectal tube or colostomy Bag) over a period of 24 hours; and
4. Has a positive result for C. difficile toxin by EIA, PCR, or a cell culture cytotoxin Neutralization assay from a sample obtained within 48 hours prior to first dose of Study drug.

Exclusion Criteria:

1. Toxic megacolon and/or known small bowel ileus;
2. Received treatment with intravenous immune globulin (IVIG) within 30 days prior to the first dose of study drug;
3. Received treatment with a fecal transplant within 7 days, and/or is anticipated to receive a fecal transplant during the study;
4. Antibacterial therapy specific for current CDAD:
• Received >4 doses or >24 hours of oral vancomycin for the current episode of CDAD prior to first dose of study drug.
• Received >4 doses or >24 hours of oral/IV metronidazole for the current episode of CDAD prior to first dose of study drug unless patient received at least 3 days of such therapy and is considered a treatment failure for CDAD.
• Received >24 hours of any other antibacterial for the current CDAD within 14 days prior to the first dose of study drug, unless considered a treatment failure for CDAD

For more information about this study, please contact Patricia Townsend directly at (720) 238-4310 or email at Patricia.Townsend@gastrorockies.com

Subject Compensation will be provided