Trial Outcomes & Findings for Maintenance Treatment for Children With Constipation (NCT NCT01566409)

NCT ID: NCT01566409

Last Updated: 2016-09-28

Results Overview

Recovery is defined as the child having no symptoms of constipation according to the Rome III criteria.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 115 participants
• Primary outcome timeframe: ½ year
• Results posted on: 2016-09-28

Participant Flow

Participant milestones

Measure	Active Maintenance Treatment Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.	Placebo Maintenance Treatment Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
Overall Study STARTED	49	53
Overall Study COMPLETED	47	48
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Maintenance Treatment for Children With Constipation

Baseline characteristics by cohort

Measure	Active Maintenance Treatment n=49 Participants Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.	Placebo Maintenance Treatment n=53 Participants Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.	Total n=102 Participants Total of all reporting groups
Age, Customized	6.2 years n=5 Participants	6.1 years n=7 Participants	6.1 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	27 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	26 Participants n=7 Participants	57 Participants n=5 Participants
Region of Enrollment Denmark	49 participants n=5 Participants	53 participants n=7 Participants	102 participants n=5 Participants

PRIMARY outcome

Timeframe: ½ year

Recovery is defined as the child having no symptoms of constipation according to the Rome III criteria.

Outcome measures

Measure	Active Maintenance Treatment n=49 Participants Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.	Placebo Maintenance Treatment n=53 Participants Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
Treatment Recovery	33 participants	19 participants

SECONDARY outcome

Timeframe: ½ year

Outcome measures

Outcome data not reported

Adverse Events

Active Maintenance Treatment

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Placebo Maintenance Treatment

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Measure	Active Maintenance Treatment n=49 participants at risk Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.	Placebo Maintenance Treatment n=53 participants at risk Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
Musculoskeletal and connective tissue disorders Broken arm	2.0% 1/49 • Number of events 1	0.00% 0/53

Other adverse events

Measure	Active Maintenance Treatment n=49 participants at risk Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.	Placebo Maintenance Treatment n=53 participants at risk Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
Gastrointestinal disorders abdominal pain	12.2% 6/49 • Number of events 12	41.5% 22/53 • Number of events 40
Gastrointestinal disorders Bloating	2.0% 1/49 • Number of events 12	0.00% 0/53
Infections and infestations Fever, upper respiratory infektion	34.7% 17/49 • Number of events 34	17.0% 9/53 • Number of events 22
Nervous system disorders Headach	2.0% 1/49 • Number of events 1	1.9% 1/53 • Number of events 1

Additional Information

Dr. Line Modin

Pediatric Department, Hospital Lillebaelt, Kolding

Phone: 0045 61386349

Email: line.modin@rsyd.dk

Results disclosure agreements

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

Restriction type: LTE60