Clinical trial NCT00101946: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: CD
Crohn's Disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-01-19
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Proportion of subjects who are responders at Week 6.
Secondary outcomes:
measure: - 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.
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: GSK Investigational Site
state: California
city: Roseville
country: United States
facility: GSK Investigational Site
state: California
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Topeka
country: United States
facility: GSK Investigational Site
state: Kansas
city: West Yarmouth
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Great Neck
country: United States
facility: GSK Investigational Site
state: New York
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Simpsonville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Levis
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: GSK Investigational Site
state: Saskatchewan
city: Quebec
country: Canada
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: