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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
683699
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring CD, Crohn's Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Proportion of subjects who are responders at Week 6.

Secondary Outcome Measures

- 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.

Full Information

First Posted
January 18, 2005
Last Updated
April 10, 2015
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00101946
Brief Title
Nine-Weeks Treatment With 683699 In Subjects With Moderately-To-Severely Active Crohn's Disease
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
CD, Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
683699
Primary Outcome Measure Information:
Title
Proportion of subjects who are responders at Week 6.
Secondary Outcome Measure Information:
Title
- 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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92840
Country
United States
Facility Name
GSK Investigational Site
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
GSK Investigational Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66614
Country
United States
Facility Name
GSK Investigational Site
City
West Yarmouth
State/Province
Massachusetts
ZIP/Postal Code
02673
Country
United States
Facility Name
GSK Investigational Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
GSK Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
GSK Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
GSK Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
GSK Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
GSK Investigational Site
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
GSK Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
GSK Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3N 2V7
Country
Canada
Facility Name
GSK Investigational Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
Facility Name
GSK Investigational Site
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
GSK Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 1J5
Country
Canada
Facility Name
GSK Investigational Site
City
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada

12. IPD Sharing Statement

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

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