Trial Outcomes & Findings for Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis (NCT NCT01059344)

NCT ID: NCT01059344

Last Updated: 2017-08-02

Results Overview

Clinical remission defined as stool frequency score of 0, rectal bleeding score of 0, no urgency

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 281 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2017-08-02

Participant Flow

November 2009 - February 2011

Screen failures, not complying to inclusion and exclusion criteria

Participant milestones

Measure	Mesalamin Mesalamin: 4.8g/day, 800 mg tablets	Placebo Placebo to Mesalamin: 4.8g/day, 800 mg tablets
Overall Study STARTED	140	141
Overall Study COMPLETED	118	95
Overall Study NOT COMPLETED	22	46

Reasons for withdrawal

Measure	Mesalamin Mesalamin: 4.8g/day, 800 mg tablets	Placebo Placebo to Mesalamin: 4.8g/day, 800 mg tablets
Overall Study Adverse Event	12	30
Overall Study Withdrawal by Subject	6	9
Overall Study Lost to Follow-up	1	1
Overall Study Other	3	6

Baseline Characteristics

Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis

Baseline characteristics by cohort

Measure	Mesalamin n=140 Participants Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.	Placebo n=141 Participants Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.	Total n=281 Participants Total of all reporting groups
Age, Continuous	42.6 years STANDARD_DEVIATION 14.3 • n=5 Participants	40.72 years STANDARD_DEVIATION 13.8 • n=7 Participants	41.8 years STANDARD_DEVIATION 14.1 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	66 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Male	87 Participants n=5 Participants	75 Participants n=7 Participants	162 Participants n=5 Participants
Race/Ethnicity, Customized White	114 participants n=5 Participants	110 participants n=7 Participants	224 participants n=5 Participants
Race/Ethnicity, Customized Asian	26 participants n=5 Participants	31 participants n=7 Participants	57 participants n=5 Participants
Region of Enrollment Turkey	13 participants n=5 Participants	11 participants n=7 Participants	24 participants n=5 Participants
Region of Enrollment Ukraine	54 participants n=5 Participants	55 participants n=7 Participants	109 participants n=5 Participants
Region of Enrollment Belarus	47 participants n=5 Participants	44 participants n=7 Participants	91 participants n=5 Participants
Region of Enrollment India	26 participants n=5 Participants	31 participants n=7 Participants	57 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: ITT

Clinical remission defined as stool frequency score of 0, rectal bleeding score of 0, no urgency

Outcome measures

Measure	Mesalamin n=140 Participants Mesalamin: 4.8g/day, 800 mg tablets	Placebo n=141 Participants Placebo to Mesalamin: 4.8g/day, 800 mg tablets
To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC).	42 participants	29 participants

SECONDARY outcome

Timeframe: 10 weeks

Population: ITT

Clinical remission defined as a score of 0 for stool frequency, 0 for rectal bleeding and no urgency

Outcome measures

Measure	Mesalamin n=140 Participants Mesalamin: 4.8g/day, 800 mg tablets	Placebo n=141 Participants Placebo to Mesalamin: 4.8g/day, 800 mg tablets
Clinical Remission	57 Participants	30 Participants

SECONDARY outcome

Timeframe: 6 weeks

Population: ITT

Endoscopic remission is defined as a sigmoidoscopy score of 1 or less

Outcome measures

Measure	Mesalamin n=140 Participants Mesalamin: 4.8g/day, 800 mg tablets	Placebo n=141 Participants Placebo to Mesalamin: 4.8g/day, 800 mg tablets
Endoscopic Remission	64 Participants	35 Participants

SECONDARY outcome

Timeframe: 10 weeks

Population: ITT

Endoscopic remission is defined as a sigmoidoscopy score of 1 or less

Outcome measures

Measure	Mesalamin n=140 Participants Mesalamin: 4.8g/day, 800 mg tablets	Placebo n=141 Participants Placebo to Mesalamin: 4.8g/day, 800 mg tablets
Endoscopic Remission	73 Participants	52 Participants

SECONDARY outcome

Timeframe: 6 weeks

Population: ITT

Improvement is defined as a reduction of at least 3 points from baseline in the modified UC-DAI score. (minumum 3, maximum 7, higher absolute UC-DAI scores indicate more severe disease)

Outcome measures

Measure	Mesalamin n=140 Participants Mesalamin: 4.8g/day, 800 mg tablets	Placebo n=141 Participants Placebo to Mesalamin: 4.8g/day, 800 mg tablets
Improvement	83 Participants	47 Participants

SECONDARY outcome

Timeframe: 10 weeks

Population: ITT

Improvement is defined as a reduction of at least 3 points from baseline in the modified UC-DAI score. (minumum 3, maximum 7, higher absolute UC-DAI scores indicate more severe disease)

Outcome measures

Measure	Mesalamin n=140 Participants Mesalamin: 4.8g/day, 800 mg tablets	Placebo n=141 Participants Placebo to Mesalamin: 4.8g/day, 800 mg tablets
Improvement	88 Participants	57 Participants

POST_HOC outcome

Timeframe: 6 weeks

Population: modified ITT, eligibility confirmed by central reader

Clinical Remission, defined as stool frequency score of 0, rectal bleeding score of 0 and absence of urgency in subjects with adequate disease extent at baseline confirmed by central reading.

Outcome measures

Measure	Mesalamin n=107 Participants Mesalamin: 4.8g/day, 800 mg tablets	Placebo n=87 Participants Placebo to Mesalamin: 4.8g/day, 800 mg tablets
To Achieve Clinical Remission in the Patient Population Confirmed by the Central Reader	31 Participants	12 Participants

Adverse Events

Mesalamin

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mesalamin n=140 participants at risk Mesalamin: 4.8g/day, 800 mg tablets	Placebo n=141 participants at risk Placebo to Mesalamin: 4.8g/day, 800 mg tablets
Gastrointestinal disorders Colitis ulcerosa	0.00% 0/140 • 19 months	2.1% 3/141 • Number of events 3 • 19 months

Other adverse events

Measure	Mesalamin n=140 participants at risk Mesalamin: 4.8g/day, 800 mg tablets	Placebo n=141 participants at risk Placebo to Mesalamin: 4.8g/day, 800 mg tablets
Investigations Monozytopenia	3.6% 5/140 • Number of events 5 • 19 months	7.1% 10/141 • Number of events 10 • 19 months
Blood and lymphatic system disorders Anaemia	6.4% 9/140 • Number of events 9 • 19 months	5.0% 7/141 • Number of events 7 • 19 months
Gastrointestinal disorders Colitis ulcerosa	9.3% 13/140 • Number of events 13 • 19 months	21.3% 30/141 • Number of events 30 • 19 months

Additional Information

Brian G. Feagan et al

The Role of Centralized Reading of Endoscopy in a Randomized Controlled Trial of Mesalamine for Ulcertive Colitis

Phone: Gastroenterology 2013; 145:

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place