Clinical Trials Logo
  1. Home
  2. Colitis, Ulcerative
  3. NCT02000453

Safety and Tolerability Study of GSK2586184 in Patients With Moderate to Severely Active Ulcerative Colitis.

Colitis, Ulcerative Clinical Trial

Official title:
An Open Label, Experimental Medicine Investigation of the Safety and Tolerability of 400 mg b.i.d. GSK2586184 in Patients With Moderate to Severely Active Ulcerative Colitis.

Clinical Trial Summary

This is an open label exploratory study to investigate the safety of 400 milligram (mg ) twice a day (b.i.d.) GSK2586184 in patients with moderate to severe, active ulcerative colitis (UC). Study medication will be administered orally (as tablets), twice daily, for up to 8 weeks (56 days). Study medication will be taken with food. Each subject will have 6 out-patient visits: Screening (Day -30 to -1); Baseline and Start of treatment (Day 1); Week 2 (Day 14); Week 4 (Day 28); Week 8 (Day 56); and Follow-up (Week 12; Day 84). Visit windows for weeks 2, 4 and 8 will be + 2 days. The primary objective of this study is to assess the safety and tolerability of GSK2586184. The primary endpoints to measure safety are laboratory tests (including haematology, clinical chemistry and serum creatinine), vital signs, 12-lead electrocardiogram (ECG), physical examination, and adverse event reporting. These are standard measurements to evaluate safety.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02000453
Study type Interventional
Source GlaxoSmithKline
Contact
Status Terminated
Phase Phase 1
Start date December 20, 2013
Completion date August 8, 2014
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04989907 - A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
Completed NCT03494764 - Hyperbaric Oxygen Therapy for Ulcerative Colitis Flares Phase 2
Recruiting NCT03937609 - TITRATE (inducTIon for acuTe ulceRATivE Colitis) Phase 4
Completed NCT00503243 - Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis Phase 3
Completed NCT03606499 - Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
Completed NCT02537210 - Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis N/A
Active, not recruiting NCT02316678 - Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics N/A
Completed NCT00488631 - An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis Phase 3
Completed NCT00928681 - A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis Phase 1
Recruiting NCT05242484 - A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis Phase 2
Completed NCT01036022 - Effect of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis Phase 2
Recruiting NCT03841045 - Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases
Active, not recruiting NCT05528510 - A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis Phase 3
Completed NCT02825914 - CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM) N/A
Recruiting NCT06049017 - A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis Phase 2
Completed NCT04567628 - Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes
Withdrawn NCT05999708 - A First Time in Human Study to Evaluate the Safety and Tolerability of GSK4381406 in Healthy Participants Phase 1
Recruiting NCT05611671 - A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC Phase 2
Active, not recruiting NCT03596645 - A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis Phase 3
Completed NCT03648541 - BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis Phase 2