Status:
COMPLETED
Nine-Weeks Treatment With 683699 In Subjects With Moderately-To-Severely Active Crohn's Disease
Lead Sponsor:
GlaxoSmithKline
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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).
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00101946
Start Date
October 1 2004
End Date
July 1 2006
Last Update
April 13 2015
Active Locations (19)
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1
GSK Investigational Site
Garden Grove, California, United States, 92840
2
GSK Investigational Site
Roseville, California, United States, 95661
3
GSK Investigational Site
Miami, Florida, United States, 33173
4
GSK Investigational Site
Topeka, Kansas, United States, 66614