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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
History of Changes
  Purpose

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).


Condition Intervention Phase
Crohn's Disease
 Drug: 683699
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

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.

Estimated Enrollment: 150
Study Start Date: October 2004
Intervention Details:
    Drug: 683699
    Other Name: 683699
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101946

  Show 19 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00101946     History of Changes
Other Study ID Numbers: 683699/004
Study First Received: January 18, 2005
Last Updated: July 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
CD
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 16, 2013