Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00101946
First received: January 18, 2005
Last updated: July 5, 2012
Last verified: June 2012

January 18, 2005
July 5, 2012
October 2004
Not Provided
Proportion of subjects who are responders at Week 6.
Not Provided
Complete list of historical versions of study NCT00101946 on ClinicalTrials.gov 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.
Not Provided
Not Provided
Not Provided
 
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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Crohn's Disease
Drug: 683699
Other Name: 683699
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
Not Provided
Not Provided

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00101946
683699/004
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2012

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