Trial Outcomes & Findings for Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis (NCT NCT00718094)

Results Overview

This Index is a measure of ulcerative colitis severity. The index assesses four variables, which include stool frequency, severity of bleeding, colonic mucosal appearance, and the physician's overall assessment of disease activity. Each variable is scored from 0-3 so that the total index score ranges from 0-12; 0-2: remission; 3-6: mild; 7-10: moderate; \>10: severe UC.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

day 56

Results posted on

2017-12-14

Participant Flow

Participant milestones

Participant milestones
Measure	Polyphenon Treatment Polyphenon E®: Oral capsules for 56 days	Placebo Placebo Oral Tablet: Oral tablet: placebo
Overall Study STARTED	15	5
Overall Study COMPLETED	15	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Polyphenon E Treatment n=15 Participants Polyphenon E®: Oral capsules	Placebo n=5 Participants Oral Placebo Placebo Oral Tablet: Oral tablet: placebo	Total n=20 Participants Total of all reporting groups
Age, Continuous	44.9 years STANDARD_DEVIATION 15 • n=5 Participants	30.7 years STANDARD_DEVIATION 14.4 • n=7 Participants	40 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	5 participants n=7 Participants	20 participants n=5 Participants
Ulcerative colitis (UC) disease activity index	6.5 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants	7.3 units on a scale STANDARD_DEVIATION 1.7 • n=7 Participants	7.0 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants

PRIMARY outcome

Timeframe: day 56

This Index is a measure of ulcerative colitis severity. The index assesses four variables, which include stool frequency, severity of bleeding, colonic mucosal appearance, and the physician's overall assessment of disease activity. Each variable is scored from 0-3 so that the total index score ranges from 0-12; 0-2: remission; 3-6: mild; 7-10: moderate; \>10: severe UC.

Outcome measures

Outcome measures
Measure	Polyphenon E Treatment n=15 Participants Polyphenon E®: Oral capsules	Placebo n=5 Participants Placebo Oral Tablet: Oral tablet: placebo
Number of Subjects With a Reduction in the Disease Activity Index of >3, or Clinical Remission.	10 Participants	0 Participants

Adverse Events

Polyphenon E Treatment

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Polyphenon E Treatment n=15 participants at risk Polyphenon E®: Oral capsules	Placebo n=5 participants at risk Placebo Oral Tablet: Oral tablet: placebo
Gastrointestinal disorders Hospitalization	6.7% 1/15 • Number of events 1 • 56 days	0.00% 0/5 • 56 days

Other adverse events

Adverse event data not reported

Additional Information

Gerald Dryden, MD

University Louisville

Phone: 502-852-0156

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place