Trial Information

Summary: New Research Takes Aim At Crohn's Disease

We are looking for study volunteers at least 18 years old who have been diagnosed for 3 months or more with Crohn’s Disease. An oral investigational drug is being evaluated at our clinical research site for people who have Crohn’s Disease.

Purpose of the study
This clinical research study will assess the safety, efficacy and tolerability of the investigational study medication for the induction and maintenance of clinical remission in study subjects who have moderate to severe Crohn’s Disease.

Study information

• Duration of the study is up to 10 weeks. Study participants will be seen at Screening (the screening period lasts up to 2 weeks), at Baseline (randomization), and at Weeks 1, 2, 4, & 8, for a total of 6 study visits. There may also be a pre-study visit for reviewing the consent form.
• Investigational study drug or placebo will be provided for oral administration twice daily. There are three different doses of the investigational study medication. Random treatment assignment will occur in a double-blinded method at a ratio of 1:1:1:1. Chance of receiving placebo is 25%.
• Study procedures include physical exams, an ECG, labwork, and pharmacokinetic sampling (to determine blood levels of the study drug at various time intervals). Visualization of the colon will be performed at screening if this has not been done within the past 24 months.
• To complete pharmacokinetic sampling, the study volunteer will need to be at the research site for approximately two and a half hours at Visits 2 & 5, and for approximately one hour at Visits 3 & 4.
• There is no charge for participation.
• A stipend will be provided to study participants for study related time and/or travel in the amount of $25 for Visits 1 & 6; $75 for Visits 2 & 5 and $45 for Visits 3 & 4 (when pharmacokinetic sampling will take place); total possible = $290. Please note that there is no stipend for the pre-study visit. If a colon procedure is performed at Visit 1 (Screen), an extra stipend of $50 will be provided for that visit.
• Investigator: John Goff, M.D. of Rocky Mountain Gastroenterology Associates

Patient Inclusion Criteria:

• Male or female, at least 18 years old
• Diagnosis of Crohn’s Disease for at least the past 3 months
• Must be in general good health besides Crohn’s Disease; other medical conditions must be well-controlled
• Must currently be receiving treatment with one of the following:
  • Oral 5-ASA or sulfasalazine at a stable dose for at least 3 weeks
  • Oral corticosteroids (prednisolone 40 mg or less or equivalent, budesonide
• 9 mg/kg or less) at a stable dose for at least 2 weeks
• Antibiotics (such as metronidazole or rifaximin) at a stable dose for at least 2 weeks
• Rectally administered formulation of corticosteroids or 5-ASA at a stable dose for at least 2 weeks
• Females who have the potential to become pregnant must be willing to use two acceptable methods of birth control during the study, and non-vasectomized males with a female partner who has the potential to become pregnant must be willing to use a condom in addition to having the female partner use another form of contraception.

Patient Exclusion Criteria:

• May not be currently receiving the following treatments:
• Immunosuppressant therapy (azathioprine/6-mercaptopurine, methotrexate, cyclosporine, mycophenolate, tacrolimus)
• Interferon therapy within the past 8 weeks
• Anti-TNF? therapy within the past 12 weeks
• For other inclusion/exclusion criteria information, please talk with a study coordinator

If you would like to learn more about participating in this study, please send an e-mail message using the form below.