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A Phase IIa Pilot Study to Determine the Safety of an Oral Dose of Green Tea Extract (Polyphenon E®) and Provide Preliminary Evidence to Support Its Efficacy in Ulcerative Colitis


Phase 2
18 Years
85 Years
Not Enrolling
Both
Mild to Moderately Active Ulcerative Colitis

Thank you

Trial Information

A Phase IIa Pilot Study to Determine the Safety of an Oral Dose of Green Tea Extract (Polyphenon E®) and Provide Preliminary Evidence to Support Its Efficacy in Ulcerative Colitis


Inclusion Criteria:



- Adult male or female with mildly to moderately active ulcerative colitis

Exclusion Criteria:

- Off prohibited medications for proscribed period of time

- Evidence of infectious colitis

- Labs outside of range

- Pregnancy or lactation

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

A reduction in the Disease Activity Index of >3, or clinical remission.

Outcome Time Frame:

Two years

Safety Issue:

No

Principal Investigator

Gerald W Dryden, MD, MSPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Louisville

Authority:

United States: Food and Drug Administration

Study ID:

390.05

NCT ID:

NCT00718094

Start Date:

March 2008

Completion Date:

April 2012

Related Keywords:

  • Mild to Moderately Active Ulcerative Colitis
  • Ulcerative colitis
  • EGCG
  • Green tea polyphenols
  • Inflammatory bowel disease
  • Colitis
  • IBD
  • Green tea
  • Colitis
  • Colitis, Ulcerative
  • Ulcer

Name

Location
University of Louisville Clinical Research Center Louisville, Kentucky  40202