Nine-Weeks Treatment With 683699 In Subjects With Moderately-To-Severely Active Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00101946
Recruitment Status : Completed
First Posted : January 19, 2005
Last Update Posted : April 13, 2015
Information provided by (Responsible Party):

January 18, 2005
January 19, 2005
April 13, 2015
October 2004
July 2006   (Final data collection date for primary outcome measure)
Proportion of subjects who are responders at Week 6.
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Complete list of historical versions of study NCT00101946 on Archive Site
- Proportion of subjects with response at other timepoints. - Proportion of subjects in remission. - Average rate of response for the CDAI score. - Mean change from baseline in CDAI score Improvement in Quality of Life.
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Nine-Weeks Treatment With 683699 In Subjects With Moderately-To-Severely Active Crohn's Disease
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
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).
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Crohn's Disease
Drug: 683699
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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July 2006
July 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
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Study Director: GSK Clinical Trials GlaxoSmithKline
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP