Mild to Moderate Ulcerative Colitis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of the Safety and Therapeutic 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 take the medicine by mouth for six weeks. Study participants will be asked to visit clinic sites where they will be asked questions about their ulcerative colitis. Small samples of blood will be be drawn at study visits to monitor the participant's health and a tiny sample of tissue will be taken in an endoscopy at two times to determine whether the disease is getting better or worse.
This is a Phase Ib/IIa prospective, multicenter, double blind, randomized, placebo
controlled, clinical study to evaluate the safety, tolerability and pilot therapeutic
activity of ORE1001, administered as capsules by mouth, for 6 weeks in subjects with
Ulcerative Colitis.
Eligible subjects will be randomly assigned to either ORE1001 or placebo, respectively.
Sigmoidoscopies with biopsies will be performed at the first treatment visit and week 6.
Subjects will be instructed to self-administer the study drug on an outpatient basis and
will be scheduled to return for clinical evaluation on weeks 2, 4, 6 and between Weeks
10-12.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01201122 -
Once Versus Twice Daily Mesalamine to Induce Remission in Pediatric Ulcerative Colitis
|
Phase 4 | |
| Completed |
NCT01033305 -
Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™)
|
Phase 2 | |
| Recruiting |
NCT05770609 -
A Study of SPH3127 in the Treatment of Mild to Moderate Ulcerative Colitis
|
Phase 2 | |
| Completed |
NCT01045018 -
A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis
|
Phase 3 |