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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00101946
• Other study ID #: 683699/004
• Status: Completed
• Phase: Phase 2
• First received: January 18, 2005
• Last updated: April 10, 2015
• Start date: October 2004
• Est. completion date: July 2006

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• 683699

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Levis	Quebec
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Saskatoon	Saskatchewan
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Windsor	Ontario
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Garden Grove	California
United States	GSK Investigational Site	Great Neck	New York
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Medford	Oregon
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Roseville	California
United States	GSK Investigational Site	Simpsonville	South Carolina
United States	GSK Investigational Site	Topeka	Kansas
United States	GSK Investigational Site	West Yarmouth	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who are responders at Week 6.
Secondary	- 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.