Clinical trials: Remission of Ulcerative Colitis
Ulcerative Colitis
Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2)
The purpose of this study is to prove the superiority of a 48-weeks treatment with 3.2 g/day delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission in patients with ulcerative colitis (UC)
- Trial name
- PROTECT-2 (NCT02280629)
- Testing
- LT-02, Mesalamine
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- Dr. Falk Pharma GmbH
Ulcerative Colitis
(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.
Randomized, double-blind, comparative study versus placebo performed in patients from studies CB-01-02/01 (NCT00679432), CB-01-02/02 (NCT00679380), or CB-01-02/06 (NCT01100112) who achieved ulcerative colitis disease activity…
- Trial name
- NCT00801723
- Testing
- Budesonide MMX 6 mg Tablet
- Where
- 58 sites in United States, Canada
- Volunteers
- 123 people
- Sponsor
- Bausch Health Americas, Inc.
Ulcerative Colitis
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis
The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.
- Trial name
- GEMINI I (NCT00783718)
- Testing
- vedolizumab
- Where
- 105 sites in United States, Canada and 1 more
- Volunteers
- 895 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Ulcerative Colitis
Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis
The objective of this study is to assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.
- Trial name
- NCT00385736
- Testing
- adalimumab
- Where
- 80 sites in United States, Austria and 11 more
- Volunteers
- 576 people
- Sponsor
- Abbott
Ulcerative Colitis, Crohn Disease
Microbial and Human Determinants of the Onset of IBD Flares
This is a longitudinal, observational study that aims to identify the microbial and human molecular triggers of IBD flares via stool, saliva, and blood metatranscriptomes, whole blood proteome, and collected clinical metadata.
- Conditions
- Ulcerative Colitis, Crohn Disease, Irritable Bowel, Crohns Disease Aggravated
- Trial name
- NCT05463900
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Viome
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.
Ulcerative Colitis
Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis
The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and…
- Trial name
- SELECTION (NCT02914522)
- Testing
- Filgotinib, PTM filgotinib
- Where
- 343 sites in United States, Argentina and 38 more
- Volunteers
- 1,351 people
- Sponsor
- Gilead Sciences
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 (UC)
A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis
Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) characterized by diffuse, continuous inflammation of the colon.
- Trial name
- NCT05316220
- Testing
- Mesalamine
- Where
- 10 sites in United States, Puerto Rico
- Sponsor
- AbbVie
Ulcerative Colitis
Observational Study in the Management of Ulcerative Colitis With Oral 5-ASA
The objectives of this study are to investigate how oral 5-ASA drugs have been used in the condition without symptoms such as abdominal pain or diarrhea/bloody stool (remission stage), or in the transition from the condition with…
- Trial name
- NCT01654783
- Where
- Japan
- Volunteers
- 5,704 people
- Sponsor
- Kyorin Pharmaceutical Co.,Ltd
Colitis, Ulcerative
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for patients with moderate to severe ulcerative colitis.
- Trial name
- EFFECT-UC (NCT06294925)
- Testing
- Etrasimod
- Where
- 41 sites in Canada, Germany and 1 more
- Volunteers
- 360 people
- Sponsor
- Pfizer
Ulcerative Colitis
Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and…
- Trial name
- NCT00151892
- Testing
- SPD476, Asacol
- Where
- 142 sites in United States, Argentina and 26 more
- Volunteers
- 829 people
- Sponsor
- Shire
Ulcerative Colitis
CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission
This dose comparison study, taking place at over 200 sites worldwide, will compare the dosing, safety and efficacy of an investigational medicine OPC-6535 to the dosing, safety and efficacy of Asacol ® in the maintenance of…
- Trial name
- NCT00092508
- Testing
- OPC-6535, Asacol®
- Where
- 26 sites in United States
- Volunteers
- 1,725 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Colitis, Ulcerative
Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.
The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.
- Trial name
- NCT00151944
- Testing
- SPD476 (mesalazine)
- Volunteers
- 400 people
- Sponsor
- Shire
Ulcerative Colitis
Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission
To evaluate the long-term safety and tolerability of encapsulated mesalamine Granules (eMG) (formerly referred to as Mesalamine Pellets [MP]) in participants with ulcerative colitis currently in remission.
- Trial name
- NCT00326209
- Testing
- Encapsulated Mesalamine Granules (eMG)
- Where
- 61 sites in United States
- Volunteers
- 393 people
- Sponsor
- Bausch Health Americas, Inc.
Colitis, Ulcerative
A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M
IBD98-M-2002 is a phase 2a , Randomized, Double blind, Placebo-controlled of IBD98-M Delayed Release capsules in subjects with Mild to Moderately Ulcerative Colitis to investigate the clinical efficacy of IBD98-M delayed release…
- Trial name
- NCT02493712
- Testing
- High dose, Low dose
- Where
- Italy
- Volunteers
- 51 people
- Sponsor
- Holy Stone Healthcare Co., Ltd
Ulcerative Colitis
Mesalamine Pellet to Maintain Remission of Mild to Moderate Ulcerative Colitis
The purpose of this study is to compare the maintenance of mild to moderate ulcerative colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day versus placebo.
- Trial name
- NCT00767728
- Testing
- Granulated mesalamine
- Where
- United States
- Volunteers
- 256 people
- Sponsor
- Bausch Health Americas, Inc.
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
Profermin® in Active Ulcerative Colitis
In this study the investigators aim was to investigate the safety and possible efficacy of Profermin® in patients with ulcerative colitis.
- Trial name
- CUPE-1 (NCT01245465)
- Testing
- Profermin
- Volunteers
- 39 people
- Sponsor
- Nordisk Rebalance A/S
Ulcerative Colitis
Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab (ADA) in patients with…
- Trial name
- NCT00408629
- Testing
- adalimumab
- Where
- 108 sites in United States, Argentina and 16 more
- Volunteers
- 518 people
- Sponsor
- Abbott