Use of Curcumin in the Lower Gastrointestinal Tract in Fa... | NCT00248053

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

NCT00248053

Sponsor

Johns Hopkins University

Status

Withdrawn

Last Update Posted

Sep 20, 2012Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Familial Adenomatous Polyposis

Interventions

curcumin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Subsequent data generated by our collaborators have shown efficacy with curcumin and quercetin in 5 patients in a non placebo controlled trial.

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Jun 2008Actual

Completion Date

Not provided

First Submitted Date

Nov 1, 2005

First Submission Date that Met QC Criteria

Nov 1, 2005

First Posted Date

Nov 3, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2012

Last Update Posted Date

Sep 20, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Francis M. Giardiello, Professor of Medicine, Johns Hopkins UniversityPrincipal Investigator

Lead Sponsor

Johns Hopkins UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lower GI	Other		Drug: curcumin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
curcumin	Drug	curcumin 500 mg by mouth, three times a day for 9 months	Lower GI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
polyp number and size		one year

Secondary Outcomes

Measure	Description	Time Frame
side effects and medication compliance		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francis M Giardiello, M.D.	Johns Hopkins University	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011125	Adenomatous Polyposis Coli

Ancestor Terms

ID	Term
D018256	Adenomatous Polyps
D000236	Adenoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003474	Curcumin

Ancestor Terms

ID	Term
D036381	Diarylheptanoids
D006536	Heptanes
D000473	Alkanes
D006839	Hydrocarbons, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided