NCT00101946

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2004

Geographic Reach
2 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

April 13, 2015

Status Verified

April 1, 2015

Enrollment Period

1.7 years

First QC Date

January 18, 2005

Last Update Submit

April 10, 2015

Conditions

Crohn's Disease

Keywords

CDCrohn's Disease

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects who are responders at Week 6.

Secondary Outcomes (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.

Interventions

683699DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

GSK Investigational Site

Garden Grove, California, 92840, United States

Location

GSK Investigational Site

Roseville, California, 95661, United States

Location

GSK Investigational Site

Miami, Florida, 33173, United States

Location

GSK Investigational Site

Topeka, Kansas, 66614, United States

Location

GSK Investigational Site

West Yarmouth, Massachusetts, 02673, United States

Location

GSK Investigational Site

Great Neck, New York, 11021, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28211, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27612, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45219, United States

Location

GSK Investigational Site

Medford, Oregon, 97504, United States

Location

GSK Investigational Site

Simpsonville, South Carolina, 29681, United States

Location

GSK Investigational Site

Memphis, Tennessee, 38120, United States

Location

GSK Investigational Site

Houston, Texas, 77030, United States

Location

GSK Investigational Site

Calgary, Alberta, T2N 4N1, Canada

Location

GSK Investigational Site

Toronto, Ontario, M3N 2V7, Canada

Location

GSK Investigational Site

Windsor, Ontario, N8X 5A6, Canada

Location

GSK Investigational Site

Lévis, Quebec, G6V 3Z1, Canada

Location

GSK Investigational Site

Québec, Quebec, G1S 4L8, Canada

Location

GSK Investigational Site

Saskatoon, Saskatchewan, S7K 1J5, Canada

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2005

First Posted

January 19, 2005

Study Start

October 1, 2004

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

April 13, 2015

Record last verified: 2015-04

Locations

CA(6)US(13)