Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn’s Disease - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00295165

Purpose

The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohn's disease.

Condition	Intervention	Phase
Crohn's Disease	Drug: Sargramostim	Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Double-Blind, Placebo-Controlled, Phase 3 Induction Study to Assess the Efficacy and Safety of 6g Sargramostim (Leukine) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn’s Disease

Further study details as provided by Bayer:

Primary Outcome Measures:

Induction of clinical response and/or remission as defined by decrease in CDAI score following 8 weeks of treatment

Secondary Outcome Measures:

Time and duration to response/remission, QoL (different methods) and safety profile of the product

Estimated Enrollment:	300
Study Start Date:	January 2006

Detailed Description:

This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

able to give informed consent
stable but active Crohn’s disease at the time of screening
must be able to self-inject or have another person who can help with the injection
must not be pregnant and agree to use birth control if sexually active male or female of childbearing potential

Exclusion Criteria:

not pregnant or breastfeeding
not have a colostomy or ileostomy
not be taking prohibited medications as defined in the protocol
not have had GI surgery or a bowel obstruction in the last 6 months or planned surgery for the next months
not have ever taken this drug or drugs of similar type in the past

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295165

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Clinical Research Center

clinical-trials-contact@bayerhealthcare.com

More Information

This study is the same study protocol as NCTNCT00295321, with different locations. This link exits the ClinicalTrials.gov site

Study ID Numbers:	310187, NOVEL8
Study First Received:	February 21, 2006
Last Updated:	May 8, 2007
ClinicalTrials.gov Identifier:	NCT00295165
Health Authority:	United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; Brazil: Ministry of Health; Bulgaria: Bulgarian Drug Agency; Canada: Health Canada; Israel: Israeli Health Ministry Pharmaceutical Administration; Romania: National Medicine agency; Russia: Pharmacological Committee, Ministry of Health; South Africa: Medicines Control Council; Ukraine: Ministry of Health; New Zealand: Scott

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

ClinicalTrials.gov processed this record on January 16, 2009