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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
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
Observational study model:
Not applicable
Primary completion date:
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
- 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.
- 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.
Inclusion and exclusion 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)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Terminated (halted prematurely)
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
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