GI-270384 Study In Patients With Mild To Moderate Ulcerative Colitis

This study has been terminated.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00457171
First received: April 4, 2007
Last updated: May 15, 2009
Last verified: May 2009
  Purpose

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 days administration of GI270384X in patients with mild to moderate active ulcerative colitis (UC).


Condition Intervention Phase
Ulcerative Colitis
Drug: GI-270384
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Phase I/II Study in Patients With Mild to Moderate Ulcerative Colitis Treated With GI-270384X, an Oral ICAM-1 and E-Selectin Inhibitor

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Modified Truelove/Witts activity index for disease severity, between baseline and week 4 Endoscopic severity at 2 weeks Quality of life, as assessed by Inflammatory Bowel Disease Questionnaire, and changes on UC imaging scanning (leukocyte scan)

Secondary Outcome Measures:
  • Vital signs (blood pressure, heart rate, body weight, 12-lead ECG), clinical laboratory data (haematology, clinical chemistry, urinalysis) and adverse events Cmax and AUC(0-4) of GI270384X, GI266193X and GW277348X after 14 days dosing.

Estimated Enrollment: 16
Study Start Date: December 2004
Intervention Details:
    Drug: GI-270384
    Other Name: GI-270384
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Females can be of childbearing or non-childbearing potential
  • Subjects who have relapsing (relapsed = 6 weeks ago; this being at least a second episode) mild to moderate UC (score of 4 - 11 on the MTWI at Screening and with an endoscopy score of = 2). Diagnosis of UC originally must be established by sigmoidoscopy or colonoscopy, and have compatible histology.
  • As confirmed through signed informed consent, the subject must understand and be able, willing and likely to fully comply with study procedures and restrictions

Exclusion criteria:

  • Subjects with severe UC according to the MTWI (score >11) and subjects who have been in relapse for > 6 weeks.
  • Subjects are not eligible for this study if they have Crohn's Disease, proctitis (where the extent of inflammation = 15 cm), bleeding disorders, or active ulcer disease.
  • Positive stool culture for enteric pathogens (including Salmonella, Shigella, Yersinia, Aeromonas, Plesiomonas or Campylobacter).
  • Presence of Clostridium difficile toxin present or with ova or parasites as detected by microscopy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457171

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, B.Sc. GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00457171     History of Changes
Other Study ID Numbers: EBD100729
Study First Received: April 4, 2007
Last Updated: May 15, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by GlaxoSmithKline:
GI-270384 colitis patients ECAM oral

Additional relevant MeSH terms:
Ulcer
Colitis, Ulcerative
Colitis
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Inflammatory Bowel Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014