Nine-Weeks Treatment With 683699 In Subjects With Moderately-To-Severely Active Crohn's Disease
NCT ID: NCT00101946
Last Updated: 2015-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
17 participants
INTERVENTIONAL
2004-10-31
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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683699
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Garden Grove, California, United States
GSK Investigational Site
Roseville, California, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Topeka, Kansas, United States
GSK Investigational Site
West Yarmouth, Massachusetts, United States
GSK Investigational Site
Great Neck, New York, United States
GSK Investigational Site
Charlotte, North Carolina, United States
GSK Investigational Site
Raleigh, North Carolina, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Medford, Oregon, United States
GSK Investigational Site
Simpsonville, South Carolina, United States
GSK Investigational Site
Memphis, Tennessee, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Calgary, Alberta, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Windsor, Ontario, Canada
GSK Investigational Site
Lévis, Quebec, Canada
GSK Investigational Site
Québec, Quebec, Canada
GSK Investigational Site
Saskatoon, Saskatchewan, Canada
Countries
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Other Identifiers
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683699/004
Identifier Type: -
Identifier Source: org_study_id
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