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Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00248053
Recruitment Status : Withdrawn (Subsequent data generated by our collaborators have shown efficacy with curcumin and quercetin in 5 patients in a non placebo controlled trial.)
First Posted : November 3, 2005
Last Update Posted : September 20, 2012
Sponsor:
Information provided by (Responsible Party):
Francis M. Giardiello, Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE November 1, 2005
First Posted Date  ICMJE November 3, 2005
Last Update Posted Date September 20, 2012
Study Start Date  ICMJE November 2005
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2007)
polyp number and size [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00248053 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2007)
side effects and medication compliance [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis Patients
Official Title  ICMJE Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis (FAP) Patients
Brief Summary The purpose of this study is to assess if curcumin, a commonly used food spice, can regress colorectal adenomatous polyps in patients with familial adenomatous polyposis, an inherited form of colorectal cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Familial Adenomatous Polyposis
Intervention  ICMJE Drug: curcumin
curcumin 500 mg by mouth, three times a day for 9 months
Study Arms  ICMJE Lower GI
Intervention: Drug: curcumin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 18, 2012)
0
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Familial adenomatous polyposis
  • 18 years of age or older
  • 5 or more adenomas of colorectum or ileum

Exclusion Criteria:

  • Female patient of child bearing age not on effective birth control pills
  • Pregnant women
  • White blood cell (WBC) count less than 4000
  • Platelets (Plts) less than 100,000
  • Blood urea nitrogen (BUN) greater than 25
  • Creatine greater than 1.5
  • Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs) during duration of trial
  • Malignancy
  • Patient with active bacterial infections of gastroesophageal reflux disease or peptic ulcer disease
  • Patient on warfarin or anti-platelet drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00248053
Other Study ID Numbers  ICMJE 05-04-12-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Francis M. Giardiello, Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francis M Giardiello, M.D. Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP