Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Arena Pharmaceuticals
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
A clinical diagnosis of Crohn's disease for at least 3 months prior to screening corroborated by prior endoscopic and histopathologic documentation consistent with Crohn's disease.
Quiescent to mildly active inflammatory Crohn's disease defined with a total of simple endoscopy score for Crohn's disease (SES-CD) score of \< 10 or fecal calprotectin \< 500 mcg/g within 4 weeks before Screening.
Moderate to severe abdominal pain as defined by average abdominal pain score (AAPS) of \>/= 4points on 7 consecutive days of the screening period up to Day -2. AAPS will be based on the 11-point numeric rating scale where 0 (no abdominal pain) to 10 (worst possible abdominal pain).
You may not be if
Female participants who are lactating or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 prior to study drug administration.
Recent history (within 6 months of screening visit) of cerebrovascular disease, Acute Coronary Syndrome, Cerebrovascular accident, Transient ischemic attack, Myocardial infarction, unstable angina.
Other significant chronic pain conditions that in the opinion of the Investigator may influence the abdominal pain score.
History of extensive colonic resection, subtotal or total colectomy.
History of \>3 small bowel resections or diagnosis of short bowel syndrome or who have undergone bowel resection within 6 months prior to randomization.
Chronic active hepatitis B within the last year (unless shown at the time of study entry to be hepatitis B antigen negative) or any history of hepatitis C.
Evidence of current gastro-intestinal infection (bacterial or parasitic) or significant infection within 45 days of screening.
