Back to resultsGI-270384 Study In Patients With Mild To Moderate Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
GI-270384
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring GI-270384 colitis patients ECAM oral
Eligibility 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.
Sites / Locations
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00457171
Brief Title
GI-270384 Study In Patients With Mild To Moderate Ulcerative Colitis
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 Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Terminated
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
GI-270384 colitis patients ECAM oral
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
16 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GI-270384
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, B.Sc.
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
GI-270384 Study In Patients With Mild To Moderate Ulcerative Colitis
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