Trial Outcomes & Findings for High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children (NCT NCT00495521)

Results Overview

Reduction in the Modified Crohn's Disease Activity Index (mCDAI) score of \>70 points by 4 weeks after randomization compared with baseline

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

4 weeks

Results posted on

2017-09-21

Participant Flow

The study was open to eligible patients under the care of or referred to investigators at 5 different academic medical centers from July 2007 through October 2008.

Recruitment was slow with only 2 patients entered.

Participant milestones

Participant milestones
Measure	Active Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks	Placebo Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
Overall Study STARTED	1	1
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks	Placebo Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
Overall Study Physician Decision	0	1

Baseline Characteristics

High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	4-Aminosalicylic Acid Extended Release Granules n=1 Participants Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks	Placebo Granules n=1 Participants Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks	Total n=2 Participants Total of all reporting groups
Age, Continuous	12 years n=5 Participants	14 years n=7 Participants	13 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Reduction in the Modified Crohn's Disease Activity Index (mCDAI) score of \>70 points by 4 weeks after randomization compared with baseline

Outcome measures

Outcome measures
Measure	Active n=1 Participants Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks	Placebo n=1 Participants Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
Reduction in the Modified Crohn's Disease Activity Index (mCDAI) Score of >70 Points by 4 Weeks Compared With Baseline	1 participants	1 participants

SECONDARY outcome

Timeframe: 4 weeks

Rate of remission was defined by a decrease in modified Crohn's Disease Activity Index (mCDAI) \> 100 points and total mCDAI \< 150 by 4 weeks

Outcome measures

Outcome measures
Measure	Active n=1 Participants Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks	Placebo n=1 Participants Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
Rate of Remission	1 Participants	1 Participants

Adverse Events

Active

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active n=1 participants at risk Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks	Placebo n=1 participants at risk Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
Gastrointestinal disorders Diarrhea	100.0% 1/1 • Number of events 1 • Duration of treatment	0.00% 0/1 • Duration of treatment
Infections and infestations Upper respiratory infection	100.0% 1/1 • Number of events 1 • Duration of treatment	0.00% 0/1 • Duration of treatment
Gastrointestinal disorders Worsening of disease, abdominal pain	100.0% 1/1 • Number of events 1 • Duration of treatment	0.00% 0/1 • Duration of treatment
General disorders Chest pain and headache	0.00% 0/1 • Duration of treatment	100.0% 1/1 • Number of events 1 • Duration of treatment
General disorders Dizziness after exercise	0.00% 0/1 • Duration of treatment	100.0% 1/1 • Number of events 1 • Duration of treatment

Additional Information

Dr. Kathy Aleš, Medical Director

Jacobus Pharmaceutical Company, Inc.

Phone: 609-921-7448

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place