Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 60 Years|
- - Signed informed consent - Age between and including 18 and 60 - Diagnosed with UC according to the Copenhagen Diagnostic Criteria - Length of disease of max.
- - Stable remission on 5-ASA (defined as partial Mayo score ≤1) for at least 2 months without need for oral corticosteroids before inclusion.
- - Endoscopic remission defined as Mayo Clinic Endoscopic Score < 2 - Have had a relapse within the last 2 years - Defined as the need of escalation of treatment or change medical treatment.
- - Evidence of infectious diarrhoea (i.e. pathogenic viruses, bacteria or Clostridium difficile toxin in stool culture) within the last month - On immunomodulators, including methotrexate - On any biological therapy - Any previous abdominal surgery related to UC - Any chronic infections (e.g. HBV, HCV, HIV) - Any severe concomitant cardiovascular, autoimmune, hematologic, hepatic, renal, endocrine, oncologic or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results - Well-founded doubt about the patient's cooperation, e.g., because of addiction to alcohol or drugs in the opinion of the investigators.
- - Participation in another clinical trial within the last 30 days, or simultaneous participation in another clinical trial.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Copenhagen University Hospital, Hvidovre|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Flemming Bendtsen, MDSci|
|Principal Investigator Affiliation||Copenhagen University Hospital, Hvidovre|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: 1600 mg Asacol (mesalazine)
1600 mg mesalazine (Asacol) treatment regimen (1 tablet per day) for a year
Active Comparator: 800 mg Asacol (mesalazine)
800 mg mesalazine (Asacol) treatment regimen (3 tablets per day) for a year
Drug: - Mesalazine
1600 mg Asacol [mesalazine]
Drug: - Mesalazine
800 mg Asacol [mesalazine]
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Flemming Bendtsen, MDSci
For additional contact information, you can also visit the trial on clinicaltrials.gov.