Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Dr. Falk Pharma GmbH
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent,
Men or women aged 18 to 75 years,
Historically confirmed diagnosis of ulcerative colitis by endoscopy and histology,
Patient being in remission, defined (according to Rachmilewitz) as:
Clinical Activity Index (CAI) \<= 4, and Endoscopic Index (EI) \< 4,
Extent of inflammation during last acute episode was \>15 cm beyond the anal margin,
Last acute episode ended within 3 months prior to study entry.
You may not be if
Crohn's disease,
Prior bowel resection leading to diarrhoea,
Toxic megacolon,
Gastric or duodenal ulcer,
Haemorrhagic diathesis,
Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of haemorrhoids or hiatal hernia),
Active colorectal cancer or a history of colorectal cancer,
Serious other secondary illnesses of an acute or chronic nature,
Asthma,
Severe impairment of renal (e.g., serum creatinine \> 1.5 mg/dl) and/or liver functions (e.g., serum transaminase \[ALT and/or AST\] or alkaline phosphatase \>=2x upper limit of normal \[ULN\]),
Application of immunosuppressants within 3 months and/or corticosteroids (oral, intravenous \[IV\] or topical rectal) within 30 days prior to baseline,
Application of non-steroidal anti-inflammatory drugs (NSAIDs) as long term treatment (i.e. \> 6 weeks), other than acetylsalicylic acid (\<= 350 mg/day), or paracetamol,
Known intolerance/hypersensitivity to salicylic acid and its derivatives or to any of the other constituents of the study drugs,
Well-founded doubt about the patient's cooperation,
Existing or intended pregnancy, breast-feeding,
Women of child-bearing potential without adequate contraceptive protection, e.g., hormonal contraception, intrauterine device (IUD), double-barrier method of contraception (e.g., use of a condom and spermicide), partner has undergone vasectomy and subject is in monogamous relationship. The investigator is responsible for determining whether the subject has adequate birth control for study participation,
Participation in another clinical trial within the last 30 days,simultaneous participation in another clinical trial, or previous participation in this trial.
