Last updated: 11/04/2018 04:04:06
Nine-Weeks Treatment With 683699 In Subjects With Moderately-To-Severely Active Crohn's Disease
GSK study ID
683699/004
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of nine-weeks administration of three doses of SB-683699 in subjects with moderately to severely active crohn's disease
Trial description: This study will evaluate the effectiveness and safety of the investigational drug 683699 in treating subjects with moderately to severely active CD (Crohn's Disease).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Number of participants who were responders at Week 6 of treatment
Timeframe: At Week 6
Secondary outcomes:
Number of participants with the indicated response at other time points
Timeframe: At Week 3
Number of participants in remission defined by a CDAI score < 150
Timeframe: Week 3 and 6
Number of participants with response or remission
Timeframe: At Week 3 and 6
Change from baseline in CDAI scores
Timeframe: Baseline (Day 1), Week 3, 6, 9, Early termination and follow-up ( Week 12)
Average rate of response for the CDAI during treatment at specified time points
Timeframe: Up to follow-up (Week 12)
Change from baseline in Harvey Bradshaw Index scores
Timeframe: Baseline (Day 1), Week 3, 6, 9, Early termination and follow-up (Week 12)
Improvements in Inflammatory Bowel Disease (IBD)-related Quality of Life (QoL) scores
Timeframe: Up to Week 12
Interventions:
Enrollment:
17
Primary completion date:
2006-10-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Crohn's Disease
Product
firategrast
Collaborators
Not applicable
Study date(s)
October 2004 to July 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Diagnosed with CD and reconfirmed in previous 2 years by a radiologic or endoscopic assessment including histology.
- CDAI (Crohn's Disease Activity Index) score of 220-450 after 1 week of screening.
- Significantly abnormal laboratory tests or ECG (electrocardiogram) results.
- Current use of an elemental diet or parenteral nutrition.
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosed with CD and reconfirmed in previous 2 years by a radiologic or endoscopic assessment including histology.
- CDAI (Crohn's Disease Activity Index) score of 220-450 after 1 week of screening.
- CRP (C-Reactive Protein) level of >4mg at screening.
Exclusion criteria:
- Significantly abnormal laboratory tests or ECG (electrocardiogram) results.
- Current use of an elemental diet or parenteral nutrition.
- Clinically significant positive stool culture.
- Ongoing neoplastic disease of the bowel.
- Bowel perforation other than fistulae.
- Has an ileostomy or colostomy.
- Fixed symptomatic gastrointestinal (GI) stricture within 6 months or obstructive symptoms within 3 months of screening.
- Any bowel resection within 12 months of screening or bowel resection without subsequent demonstration of recurrence of active CD.
- More than 100cm of bowel resected.
- Non-curative bowel surgery with 2 months of screening.
- Symptoms attributed to short bowel syndrome.
- Uncontrolled bacterial, viral, or fungal infection or congenital or acquired immunodeficiency.
- Women who are pregnant, breast feeding, or planning to become pregnant during the study. Permitted medications:
- Less than or equal to 20mg/day oral corticosteroids for at least 4 weeks prior to screening and on stable doses for 2 weeks prior to screening.
- Azathioprine and 6-MP (6-Mercaptopurine) stable dose for 3 months prior to screening.
- 5-ASA (5-Aminosalicylic acid) stable dose for 1 month prior to screening. Prohibited medications:
- Greater than 20mg/day oral corticosteroids, or systemic intravenous corticosteroids, or antibiotics as a treatment for CD within 4 weeks prior to screening.
- Cyclosporine or methotrexate during the 2 months prior to screening.
- Infliximab or other biological treatments within 3 months prior to screening.
Trial location(s)
Location
GSK Investigational Site
Altoona, Pennsylvania, United States, 16602
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29425
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Galveston, Texas, United States, 77555
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Kansas, United States, 64131
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Garden Grove, California, United States, 92840
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M3N 2V7
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28801
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Great Neck, New York, United States, 11021
Status
Recruiting
Location
GSK Investigational Site
Burlington, Massachusetts, United States, 01805
Status
Terminated/Withdrawn
Location
GSK Investigational Site
West Yarmouth, Massachusetts, United States, 02673
Status
Study Complete
Location
GSK Investigational Site
Cleveland, Ohio, United States, 44195
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 1J5
Status
Study Complete
Location
GSK Investigational Site
Lakewood, Colorado, United States, 80215
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Arlington Heights, Illinois, United States, 60005
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45219
Status
Study Complete
Location
GSK Investigational Site
Chevy Chase, Maryland, United States, 20815
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Simpsonville, South Carolina, United States, 29681
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M5G 1X5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Oro Valley, Arizona, United States, 85739
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28211
Status
Study Complete
Location
GSK Investigational Site
Egg Harbor Township, New Jersey, United States, 08234
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40202
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Metairie, Louisiana, United States, 70001
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Roseville, California, United States, 95661
Status
Study Complete
Location
GSK Investigational Site
Trumbull, Connecticut, United States, 06611
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Portland, Oregon, United States, 97239
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38120
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60637
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Torrington, Connecticut, United States, 06790
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Winter Park, Florida, United States, 32789
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Los Angeles, California, United States, 90048
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Anaheim, California, United States, 92801
Status
Terminated/Withdrawn
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2006-10-07
Actual study completion date
2006-10-07
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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