Clinical trials: Mild-to-moderate Ulcerative Colitis
Proctitis, Ulcerative
Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis
This is a prospective, multicenter, double-blind (DB), controlled, randomized, parallel group comparison Phase 3a study to evaluate the efficacy and safety of new mesalamine suppositories (MAX-002) as compared to placebo and…
- Trial name
- NCT01016262
- Testing
- MAX-002, Canasa®
- Where
- 40 sites in United States, Canada and 1 more
- Volunteers
- 119 people
- Sponsor
- Forest Laboratories
Mild to Moderate Ulcerative Colitis
Safety and Activity of ORE1001 in Subjects With Ulcerative Colitis
A clinical trial is being conducted to test the effects of a potential new treatment in patients with ulcerative colitis. Study participants will be given capsules containing either ORE1001 or a matching placebo capsule and will…
- Trial name
- NCT01039597
- Testing
- ORE1001
- Where
- 7 sites in Canada, India
- Volunteers
- 50 people
- Sponsor
- Ore Pharmaceuticals, Inc.
Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD)
AIM-IBD: A Microbiome-Targeted Supplement in Mild-to-Moderate Ulcerative Colitis
This Phase 2b randomized, double-blind, placebo-controlled, multicenter trial will evaluate the efficacy and safety of a once-daily oral microbiome-targeted food supplement compared with matching placebo in adults with…
- Conditions
- Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD), Colitis
- Trial name
- AIM-IBD (NCT07619638)
- Testing
- Microbiome-Targeting Nutraceutical
- Where
- Turkey (Türkiye)
- Volunteers
- 162 people
- Sponsor
- ENBIOSIS BIOTECHNOLOGIES
Ulcerative Colitis
A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis
The study is designed to investigate efficacy and safety of KBL697 in patients with mild to moderate active ulcerative colitis. KBL697 has been developed as a potential new treatment for ulcerative colitis.
- Trial name
- NCT04898348
- Testing
- KBL697
- Where
- Australia
- Sponsor
- KoBioLabs
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.
Ulcerative Colitis
GI-270384 Study In Patients With Mild To Moderate Ulcerative Colitis
The aim of this double blind, placebo controlled, study is to evaluate activity consistent with efficacy provided by 14 days administration of GI270384X, and to provide preliminary pharmacokinetics and safety/tolerability of 14…
- Trial name
- NCT00457171
- Testing
- GI-270384
- Volunteers
- 16 people
- Sponsor
- GlaxoSmithKline
Ulcerative Colitis
Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)
This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of remission in participants with active mild or moderate ulcerative…
- Trial name
- NCT01532648
- Testing
- Budesonide MMX®, 5-ASA
- Where
- 114 sites in United States, Bulgaria and 9 more
- Volunteers
- 510 people
- Sponsor
- Bausch Health Americas, Inc.
Ulcerative Colitis
Phase II Study of HMPL-004 in Patients With Ulcerative Colitis
The purpose of this study is to evaluate the safety and efficacy of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), compared with placebo.
- Trial name
- NCT00659802
- Testing
- HMPL-004 low dose, HMPL-004 high dose
- Volunteers
- 224 people
- Sponsor
- Hutchison Medipharma Limited
Ulcerative Colitis
A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis
To explore the safety of FE 999322 (microbiota suspension) and FE 999324 (microbiota capsule) versus placebo in subjects with active mild to moderate ulcerative colitis (UC).
- Trial name
- NCT06260267
- Testing
- Microbiota suspension, Microbiota capsule
- Where
- 10 sites in United States
- Sponsor
- Ferring Pharmaceuticals
Ulcerative Colitis
A Safety Study of Lactobacillus Reuteri BGP-014 in Patients With Ulcerative Colitis
The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of Lactobacillus reuteri BGP-014 in mild to moderate active Ulcerative Colitis (UC) patients as an oral administered local treatment…
- Trial name
- NCT05118919
- Testing
- BGP-014
- Where
- 4 sites in Sweden
- Volunteers
- 35 people
- Sponsor
- BioGaia Pharma AB
Ulcerative Colitis
Safety and Pharmacokinetics Study of HE3286 in Patients With Active, Mild-to-Moderate Ulcerative Colitis
The purpose of this pilot, exploratory study is to evaluate the safety, tolerance, pharmacokinetics and potential activity of an investigational agent, HE3286, when administered orally, daily for 28 days to patients with…
- Trial name
- NCT00628433
- Testing
- HE3286
- Where
- 10 sites in United States
- Volunteers
- 27 people
- Sponsor
- Harbor Therapeutics
Colitis, Ulcerative
(CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release Tablets
Open-label, 8 week study, to assess the efficacy and safety of oral Budesonide-MMX 9 mg Extended-release Tablets in patients with mild to moderate, active ulcerative colitis who are not in remission based on the Ulcerative…
- Trial name
- NCT01100112
- Testing
- Budesonide
- Where
- 15 sites in India
- Volunteers
- 61 people
- Sponsor
- Bausch Health Americas, Inc.
Left-Sided Ulcerative Colitis, Proctosigmoiditis
Safety, Tolerability, Efficacy Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis
PUR 0110 is a 100% natural novel investigational medicinal product that has been demonstrated in several in vitro and in vivo pharmacology studies to have potent anti-inflammatory, anti-oxidative and immunomodulatory effects.
- Trial name
- NCT01149707
- Testing
- PUR 0110 Rectal Enema 250 mg, PUR 0110 Rectal Enema 500 mg, PUR 0110 Rectal Enema 1000 mg
- Where
- 6 sites in Germany
- Volunteers
- 34 people
- Sponsor
- PurGenesis Technologies Inc.
Mild-to-moderate Ulcerative Colitis
Study to Assess Effectiveness of Therapy Timely Adjustment Based on Self-monitoring in Patients Suffering From Mild-to-moderate Ulcerative Colitis (OPTIMISE Study)
The purpose of this study is to provide evidence that a therapy of Ulcerative Colitis (UC) disease adjusted on tight monitoring of non-invasive parameters, such as clinical symptoms and faecal calprotectin (FC) (substance that is…
- Trial name
- OPTIMISE (NCT04340895)
- Testing
- Faecal Calprotectin Home Test, PRO-2 Scoring
- Where
- 42 sites in Czechia, Hungary and 4 more
- Volunteers
- 250 people
- Sponsor
- Ferring Pharmaceuticals
Ulcerative Colitis
Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis
The primary objective of the study is to determine the efficacy of Asacol™ 4.8 g/day (800 mg tablets) to induce clinical and endoscopic remission after 6 weeks of treatment compared to placebo in subjects with active ulcerative…
- Trial name
- NCT01059344
- Testing
- Mesalamin
- Where
- 31 sites in Belarus, India and 2 more
- Volunteers
- 281 people
- Sponsor
- Tillotts Pharma AG
Ulcerative Colitis
A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With Ulcerative Colitis
This study will examine the safety and efficacy in subjects with mild to moderate ulcerative colitis, as measured by Modified Mayo Score, Modified Baron Score, IBDQ, calprotectin and other assessments.
- Trial name
- NCT01839214
- Testing
- VB-201 160mg
- Where
- 3 sites in Bulgaria, Hungary and 1 more
- Volunteers
- 112 people
- Sponsor
- Vascular Biogenics Ltd. operating as VBL Therapeutics
Ulcerative Colitis
Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)
The purpose of this trial is to investigate the efficacy of mesalamine for the induction of clinical and endoscopic remission in subjects with active, mild to moderate UC.
- Trial name
- NCT02522767
- Testing
- Mesalamine
- Where
- 93 sites in United States, Bulgaria and 9 more
- Volunteers
- 228 people
- Sponsor
- Ferring Pharmaceuticals
Ulcerative Colitis, Inflammatory Bowel Disease
Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis
To explore the safety of orally delivered rhIL-11 in patients with mild to moderate left-sided ulcerative colitis. To explore the effects of orally administered rhIL-11 on pharmacogenomics in blood samples and in colonic biopsy…
- Trial name
- NCT00038922
- Testing
- rhIL-11
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Ulcerative Colitis
Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis
To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.
- Trial name
- PACE (NCT02093663)
- Testing
- MMX Mesalamine/Mesalazine (Low Dose), MMX Mesalamine/Mesalazine (High Dose)
- Where
- 33 sites in United States, Canada and 5 more
- Volunteers
- 107 people
- Sponsor
- Shire
Ulcerative Colitis
Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis
The primary objective of the study was to compare the percentage of subjects in remission after 8 weeks of treatment with SPD476, 2.4 g/day once daily vs placebo and SPD476 4.8 g/day once daily versus placebo
- Trial name
- NCT00548574
- Testing
- SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine, Mesalazine
- Where
- Belgium
- Volunteers
- 343 people
- Sponsor
- Shire