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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00457171
Recruitment Status : Terminated
First Posted : April 5, 2007
Last Update Posted : May 18, 2009
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Brief Summary:
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 or disease Intervention/treatment Phase
Ulcerative Colitis Drug: GI-270384 Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
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
Study Start Date : December 2004

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Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00457171

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

Responsible Party: Study Director, GSK Identifier: NCT00457171     History of Changes
Other Study ID Numbers: EBD100729
First Posted: April 5, 2007    Key Record Dates
Last Update Posted: May 18, 2009
Last Verified: May 2009

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

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