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

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

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).

Study Overview

• Status: Terminated
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: GI-270384

• Study Type: Interventional
• Enrollment: 16
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, B.Sc., GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: April 4, 2007
• First Submitted That Met QC Criteria: April 4, 2007
• First Posted (Estimate): April 5, 2007

Study Record Updates

• Last Update Posted (Estimate): May 18, 2009
• Last Update Submitted That Met QC Criteria: May 15, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: GI-270384 colitis patients ECAM oral
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: EBD100729

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No