Trial Outcomes & Findings for Comparison Trial of Enema vs. PEG 3350 for Constipation (NCT NCT00467350)

NCT ID: NCT00467350

Last Updated: 2020-11-02

Results Overview

On day 5, the number of participants who respond "improved" to the question "Has your child's main symptom improved, stayed the same or gotten worse?"

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: 5 days
• Results posted on: 2020-11-02

Participant Flow

A convenience sample of patients aged 1 to 17 years was recruited between December 2006 and May 2009 from a pediatric emergency department.

There were no significant events that occurred after enrollment and before study arm assignment.

Participant milestones

Measure	Enema milk and molasses enema: enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance	PEG 3350 PEG 3350: PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance
Overall Study STARTED	41	39
Overall Study COMPLETED	40	39
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison Trial of Enema vs. PEG 3350 for Constipation

Baseline characteristics by cohort

Measure	Enema n=40 Participants Rectal enema containing mixture of milk and molasses milk and molasses enema: enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance	PEG 3350 n=39 Participants Medication to be taken orally once each day for three consecutive days PEG 3350: PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance	Total n=79 Participants Total of all reporting groups
Age, Continuous	6.8 years STANDARD_DEVIATION 0.7 • n=5 Participants	6.9 years STANDARD_DEVIATION 0.7 • n=7 Participants	6.9 years STANDARD_DEVIATION 0.5 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	20 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants
Race/Ethnicity, Customized White	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized African American	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized other	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	40 Participants n=5 Participants	39 Participants n=7 Participants	79 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days

On day 5, the number of participants who respond "improved" to the question "Has your child's main symptom improved, stayed the same or gotten worse?"

Outcome measures

Measure	Enema n=40 Participants milk and molasses enema: enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance	PEG 3350 n=39 Participants PEG 3350: PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance
The Number of Participants With Main Symptom Improvement	28 Participants	22 Participants

Adverse Events

Enema

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

PEG 3350

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Enema n=40 participants at risk milk and molasses enema: enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance	PEG 3350 n=39 participants at risk PEG 3350: PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance
Gastrointestinal disorders treatment failure	2.5% 1/40 • Number of events 1	10.3% 4/39 • Number of events 4

Additional Information

Melissa Miller MD

Children's Mercy Hospitals and Clinics

Phone: 8162343000

Email: mmiller@cmh.edu

Results disclosure agreements

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