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||16 Years - 75 Years|
- - Male and female patients, 16 to 75 years old, diagnosed with ulcerative colitis.
- - Diagnosis of ulcerative colitis in active phase of mild to moderate entity.
- - Female patients must fulfill at least one of the following criteria: Post-menopausal (women ≥45 years with no menstrual period for at least 12 months without an alternative medical cause), surgically sterile, using a medically approved contraception throughout the trial period or her male partner using medically approved contraception throughout the trial period.
- - Male patients must agree to use medically approved contraception throughout the trial period.
- - Patients with limited distal proctitis.
- - Patients with infectious colitis.
- - Patients with history of colectomy.
- - Patients with severe diseases in other organs and systems.
- - Evidence or history of toxic megacolon.
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.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: Budesonide (6 mg)
Experimental: Budesonide (9 mg)
Active Comparator: Mesalazine (3,600 mg)
Drug: - Budesonide (6 mg)
Budesonide (6 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.
Drug: - Budesonide (9 mg)
Budesonide (9 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.
Drug: - Mesalazine (3,600 mg)
Mesalazine (3,600 mg) administered once a day plus three mesalazine 400 mg three times a day, over an 8-week treatment period.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.