Clinical trials: Mild to Moderately Active Ulcerative Colitis
Ulcerative Colitis
Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis
The primary objective of this study is to evaluate the efficacy (as measured by induction of remission) of two dose levels (low and high) per age group (5 to <12 and 12 to ≤17 years) of budesonide rectal foam as compared to an…
- Trial name
- NCT05976802
- Testing
- High dose budesonide rectal foam, Low dose budesonide rectal foam
- Volunteers
- 100 people
- Sponsor
- Bausch Health Americas, Inc.
Colitis, Ulcerative
Confirmatory Clinical Study in Active Ulcerative Colitis
The main goal of the study is to check if MH002 works and is safe to use. In a previous study in 45 patients with Ulcerative Colitis, MH002 was found to have favorable effects.
- Trial name
- StarFish-UC (NCT07296315)
- Testing
- Low-dose MH002, High-dose MH002
- Where
- 49 sites in United States, Czechia and 5 more
- Volunteers
- 204 people
- Sponsor
- MRM Health NV
Ulcerative Colitis
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis
This is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (PK) of budesonide extended-release tablets for the induction of remission in pediatric subjects…
- Trial name
- NCT04314375
- Testing
- Low Dose Budesonide, High Dose Budesonide
- Where
- 4 sites in United States
- Volunteers
- 70 people
- Sponsor
- Bausch Health Americas, Inc.
Colitis, Ulcerative
To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis
To demonstrate non-inferiority in efficacy of FE 999315 to mesalazine in patients with mild to moderate active ulcerative colitis after 8 weeks of treatment.
- Trial name
- NCT03412682
- Testing
- Budesonide (6 mg), Budesonide (9 mg), Mesalazine (3,600 mg)
- Where
- 72 sites in Japan
- Volunteers
- 274 people
- Sponsor
- Ferring Pharmaceuticals
Ulcerative Colitis
Microbiota-targeted Diet for Pediatric UC
Ulcerative colitis is a chronic inflammatory disease primarily involving the colon and has long been considered to be due to a dysregulated immune response targeting the colon, and involves unknown environmental factors.
- Trial name
- UCD (NCT02922881)
- Testing
- Ulcerative Colitis Diet (UCD)
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Children's Hospital of Philadelphia
Ulcerative Colitis (UC)
Use of a Novel Diet (UC DIET) for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis
The goal of the study is to evaluate strategies that target the microbiota for the treatment of Ulcerative Colitis , This study will involve a novel diet that the investigators developed , based on the hypothesis that UC involves…
- Trial name
- NCT02345733
- Testing
- Ulcerative Colitis Diet, Antibiotic cocktail
- Where
- 3 sites in United States, Canada and 1 more
- Volunteers
- 20 people
- Sponsor
- Prof. Arie Levine
Ulcerative Colitis
Combination of Diet and 5ASA ( 5-aminosalicylic Acid) for Ulcerative Colitis
Combination Therapy with Drug and Diet for Induction of Remission in Mild to Moderate Active Pediatric Ulcerative colitis: A Single Blinded, International Randomized Controlled Trial
- Trial name
- INDUCT (NCT03980405)
- Testing
- Group 1- Control Diet, Group 2- UCD Diet
- Where
- Israel
- Volunteers
- 12 people
- Sponsor
- Prof. Arie Levine
Ulcerative Colitis
Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis
The overall objective of this study is to assess the safety and efficacy of high dose and low dose Asacol administered as 400 mg delayed-release tablets given every 12 hours for 6 weeks to children and adolescents with…
- Trial name
- NCT00713310
- Testing
- Asacol 400 mg
- Where
- 42 sites in United States, Canada and 3 more
- Volunteers
- 83 people
- Sponsor
- Warner Chilcott