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||15 Years and Over|
- - Patients who were diagnosed with UC during the index period.
- - Patients who had at least two claims of 5-ASA (sulfasalazine, balsalazide, mesalamine) during the index period.
- - Patients who underwent at least one endoscopy within a 3-month period prior to the index date (i.e. the first date of diagnosis with UC).
- - Defined as a claim with relevant endoscopy procedure code.
- - Include the upper gastrointestinal endoscopy, colonoscopy, sigmoidoscopy, which are identified using the procedure code.
- - Patients who were treated with 5-ASA continuously for at least 1-month after the index date.
- - Defined as those who were treated with 5-ASA for more than 30 days within 6-month after the index date (i.e. the first date of diagnosis with UC).
- - Patients less than 15 years old as of the index date (<15 years old).
- - Patients who were treated with 5-ASA during the baseline period (i.e. 12-month prior to the index date).
- - Patients who were diagnosed with UC during the baseline period.
- - Patients who received steroids, immunosuppressants, or biologics during the baseline period.
- - Steroid includes both oral medication and intravenous (IV) injection.
- - Immunosuppressants is defined as at least one claim with Azathioprine or 6-Mercaptopurine.
- - Biologics is defined as at least one claim with Infliximab, Adalimumab, Ustekinumab, Vedolizumab, Golimumab, or Tofacitinib.
- - Patients who were diagnosed with Crohn's disease at any time in the overall study period.
- - Defined as a claim with relevant Crohn's disease code recorded as primary diagnosis during the baseline period or follow-up period (i.e. entire study period).
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.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Global Clinical Compliance|
|Principal Investigator Affiliation||Ferring Pharmaceuticals|
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.
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:
Global Clinical Compliance
For additional contact information, you can also visit the trial on clinicaltrials.gov.