Last updated: 11/04/2018 06:13:20

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

GSK study ID
EBD100729
Clinicaltrials.gov ID
NCT00457171
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: GI-270384
    • Enrollment:
    16
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Ulcerative colitis
    Product
    GI270384
    Collaborators
    Not applicable
    Study date(s)
    December 2004 to May 2005
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 Years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Females can be of childbearing or non-childbearing potential
    Inclusion and exclusion criteria
    Inclusion 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-27-05

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website