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):

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).

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: 683699 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : October 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Primary Outcome Measures :
  1. Proportion of subjects who are responders at Week 6.

Secondary Outcome Measures :
  1. - 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00101946

  Hide Study Locations
United States, California
GSK Investigational Site
Garden Grove, California, United States, 92840
GSK Investigational Site
Roseville, California, United States, 95661
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33173
United States, Kansas
GSK Investigational Site
Topeka, Kansas, United States, 66614
United States, Massachusetts
GSK Investigational Site
West Yarmouth, Massachusetts, United States, 02673
United States, New York
GSK Investigational Site
Great Neck, New York, United States, 11021
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28211
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45219
United States, Oregon
GSK Investigational Site
Medford, Oregon, United States, 97504
United States, South Carolina
GSK Investigational Site
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
GSK Investigational Site
Memphis, Tennessee, United States, 38120
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030
Canada, Alberta
GSK Investigational Site
Calgary, Alberta, Canada, T2N 4N1
Canada, Ontario
GSK Investigational Site
Toronto, Ontario, Canada, M3N 2V7
GSK Investigational Site
Windsor, Ontario, Canada, N8X 5A6
Canada, Quebec
GSK Investigational Site
Levis, Quebec, Canada, G6V 3Z1
Canada, Saskatchewan
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 1J5
GSK Investigational Site
Quebec, Canada, G1S 4L8
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00101946     History of Changes
Other Study ID Numbers: 683699/004
First Posted: January 19, 2005    Key Record Dates
Last Update Posted: April 13, 2015
Last Verified: April 2015

Keywords provided by GlaxoSmithKline:
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases