Clinical trials: Mild to Moderate Ulcerative Colitis
Ulcerative Colitis
New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis
The purpose of this study is to establish the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with mildly to moderately…
- Trial name
- NCT00269438
- Testing
- 5 ASA, enemas, suppositories, corticosteroids
- Where
- 66 sites in United States
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Ulcerative Colitis
A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)
A 2-part study, comprising of a 36-week placebo-controlled period (PCP) and a 24-week open-label extension (OLE) period, to assess the efficacy and safety of 2 dose regimens of GB004 when added to background UC therapy of…
- Trial name
- NCT04556383
- Testing
- GB004
- Where
- 77 sites in United States, Georgia and 7 more
- Volunteers
- 236 people
- Sponsor
- GB004, Inc.
Ulcerative Colitis
Prospective, Longitudinal Multicentric Survey in the Therapeutic Care of Mild to Moderate Ulcerative Colitis
The primary objective of this study is to confirm the long-term efficacy (remission and maintenance in remission) of current validated treatments. Each patient will be followed during 3 years in this non-interventional trial.
- Trial name
- OPTIMUM (NCT01387698)
- Where
- 158 sites in France
- Volunteers
- 812 people
- Sponsor
- Ferring Pharmaceuticals
Ulcerative Colitis
PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative Colitis
Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) characterized by chronic inflammation limited to colonic mucosa. Its pathogenesis is not still clear, even if a multifactorial aetiology has been advocated.
- Trial name
- PROREM UC (NCT03415711)
- Testing
- VSL#3®, Mesalamine
- Where
- Italy
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- VSL Pharmaceuticals
Ulcerative Colitis (UC)
LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis (UC)
A Phase 1b study to evaluate the safety and tolerability of LIV001 in Patients with Mild-to- Moderate Active Ulcerative Colitis
- Trial name
- NCT06749795
- Testing
- LIV001
- Where
- Poland
- Volunteers
- 15 people
- Sponsor
- Liveome Inc.
Colitis, Ulcerative
Efficacy/Safety Pilot Study to Investigate Iberogast N's Efficacy in Mild to Moderate Colitis Ulcerosa Patients
The study will investigate efficacy of STW5-II as add-on therapy on the rate to remission in patients with mild to moderate ulcerative colitis in an acute flare.
- Trial name
- NCT02246686
- Testing
- STW5-II (Iberogast N, BAY98-7410)
- Where
- 8 sites in Germany
- Volunteers
- 3 people
- Sponsor
- Bayer
Ulcerative Colitis
A Study to Evaluate the Efficacy and Safety of ZYIL1 Oral Capsules for the Treatment of Patients With Mild to Moderately Active Ulcerative Colitis Resistant or Intolerant to Oral Aminosalicylates
The purpose of this study is to evaluate efficacy and safety of ZYIL1 oral capsule twice a day for 12 weeks for treatment of mild to moderate active ulcerative colitis resistant or intolerant to oral aminosalicylates.
- Trial name
- NCT06398808
- Testing
- Arm1, Arm 2
- Where
- India
- Volunteers
- 24 people
- Sponsor
- Zydus Lifesciences Limited
Colitis, Ulcerative
Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476
Evaluate the percentage of subjects in remission at the end of an 8-week treatment period for three dose groups (SPD476 1.2 g/day, 2.4 g/day or 4.8 g/day, administered once daily).
- Trial name
- NCT00545389
- Testing
- SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine
- Where
- Belgium
- Volunteers
- 38 people
- Sponsor
- Shire
Mild to Moderate Ulcerative Colitis
A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis
The objectives of this bioequivalence study in patients with ulcerative colitis (UC) were: To establish the therapeutic equivalence of mesalamine delayed release tablet (MDRT) and Asacol Delayed Release Tablets 2.4 g per day (800…
- Trial name
- NCT01045018
- Testing
- Mesalamine
- Sponsor
- EMET Pharmaceuticals, LLC
Ulcerative Colitis
Open Label Study to Assess Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis
This is a proof of concept, randomized, open label, 2-arm study of OPRX-106 in subjects with active mild to moderate ulcerative colitis.
- Trial name
- NCT02768974
- Testing
- OPRX-106
- Where
- 7 sites in Israel
- Volunteers
- 20 people
- Sponsor
- Protalix
Ulcerative Colitis
HMPL-004 Maintenance Treatment in Subjects With Mild to Moderate Ulcerative Colitis
A study with an 8 week open label phase study followed by a year long placebo controlled maintenance phase in subjects with active mild to moderate ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy…
- Trial name
- NATRUL-4 (NCT01882764)
- Testing
- HMPL-004
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Hutchison Medipharma Limited
Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate
ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis
Phase 1B randomized, double-blind, placebo-controlled, two-cohort clinical trial of ABI-M201 in adult subjects with mildly-to-moderately active Ulcerative Colitis(UC) and ongoing treatment with mesalamine.
- Trial name
- NCT03923478
- Testing
- ABI-M201
- Where
- 11 sites in United States, Canada
- Volunteers
- 15 people
- Sponsor
- Assembly Biosciences
Ulcerative Colitis
Efficacy and Tolerability of a New Oral Extended-Release Formulation Containing Parnaparin Sodium, Administered Add-on Therapy
The objective of this study is to evaluate the efficacy and the tolerability of oral parnaparin sodium (210mg), administered in extended-release tablets identified as CB-01-05-MMX™.
- Trial name
- NCT00867438
- Testing
- Sigmoidoscopy
- Volunteers
- 133 people
- Sponsor
- Cosmo Technologies Ltd
Ulcerative Colitis
A Clinical Study to Assess the Effects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and Function
This exploratory, open-label clinical study aims to explore the effects of KB295, a novel glycan, on adult patients with ulcerative colitis (UC) presenting with mild-to-moderate UC symptoms
- Trial name
- NCT04508413
- Testing
- KB295
- Where
- 3 sites in United States, Ireland
- Volunteers
- 12 people
- Sponsor
- Kaleido Biosciences
Colitis, Ulcerative
Effect of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis
This study is the first-time-in-patient trial of GSK1399686, a novel locally-acting anti-inflammatory compound, aimed at obtaining initial information on the tolerability, safety, pharmacokinetics (including concentrations in…
- Trial name
- NCT01036022
- Testing
- GSK1399686
- Where
- 26 sites in Belgium, Canada and 3 more
- Volunteers
- 120 people
- Sponsor
- GlaxoSmithKline
Ulcerative Colitis
Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis
The study will assess the efficacy and safety of oral MT-1303 compared to placebo at 12 weeks as the induction treatment in subjects with active mild to moderate ulcerative colitis (UC), as well as maintenance treatment with…
- Trial name
- NCT04857112
- Testing
- Low Dose MT-1303, High Dose MT-1303, MT-1303
- Where
- 185 sites in United States, Australia and 17 more
- Volunteers
- 322 people
- Sponsor
- Bausch Health Americas, Inc.
Colitis, Ulcerative
Phase III Multicentre Trial of Oral Mesalazine in Patients With Mild to Moderate Ulcerative Colitis.
A randomised, double-blind, double-dummy, multicentre, phase III, non inferiority trial of an oral mesalazine formulation in patients with active mild to moderate ulcerative colitis for the induction of remission.
- Trial name
- NCT06176560
- Testing
- Mesalazine
- Volunteers
- 376 people
- Sponsor
- Faes Farma, S.A.
Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects
TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)
This study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single-dose TD-3504 and single dose 15N2-tofacitinib in healthy subjects and subjects with UC.
- Trial name
- NCT03103412
- Testing
- TD-3504, 15N2-tofacitinib
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Active Ulcerative Colitis, Remission of Ulcerative Colitis
Canadian Active & Maintenance Modified Pentasa Study
The purpose of this study is to demonstrate that the new modified oral extended-release Pentasa® 500mg tablet is at least as efficacious as the currently marketed Pentasa® 500mg tablet in active mild to moderate Ulcerative…
- Trial name
- CAMMP (NCT00603733)
- Testing
- 5-ASA (5-Aminosalicylate)
- Where
- 27 sites in Canada
- Volunteers
- 288 people
- Sponsor
- Ferring Pharmaceuticals
Ulcerative Colitis
A Phase 1b Trial to Evaluate the Safety of MB310 in Patients With Active, Mild-to-Moderate Ulcerative Colitis
A Phase 1b study to evaluate the safety and tolerability of MB310 given to patients who have active mild-to-moderate ulcerative colitis.
- Trial name
- COMPOSER-1 (NCT06582264)
- Testing
- MB310, Vancomycin
- Where
- 22 sites in Austria, Bulgaria and 3 more
- Volunteers
- 29 people
- Sponsor
- Microbiotica Ltd