An Open Single Centre Study To Assess Treatment of Chronic Constipation in Children
|Chronic Constipation||Drug: Polyethylene glycol 3350 Na bicarbonate NaCl KCl||Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Open Single Centre Study To Assess the Safety and Efficacy of Movicol in the Treatment of Chronic Constipation in Children|
- The average number of spontaneous complete defaecations per week recorded over the period of treatment between scheduled visits.
- Assessment of
- abdominal pain
- amount of stool
- faecal form (Bristol stool scale)
- rectal bleeding
- pain on defaecation
- straining on defaecation
- stool withholding
- faecal incontinence (soiling)
- efficacy (investigator and parental assessment)
- concomitant laxative treatment
|Study Start Date:||August 2001|
|Estimated Study Completion Date:||January 2003|
Ages 2 - 6: Day 1= 1 sachet/day; Day 3= 1 sachet BID; Day 5= 1 sachet TID Ages 7 - 11: Day 1= 1 sachet BID; Days 3 & 5 = 2 sachets BID;
Drug: Polyethylene glycol 3350 Na bicarbonate NaCl KCl
6.9g sachet, oral
Other Name: MOVICOL
This was a phase III, open, single centre, non-comparative study. All patients were assigned to treatment with Movicol for a period of 12 weeks.
All patients were screened at Day 0 (Visit 1) when baseline assessment of their bowel movements over the previous 14 days were made. Patients were dispensed with Movicol to commence treatment on the following day (Day 1). During the first 5 days the dose was increased on an every second day basis until normal bowel movement was achieved. Thereafter until the end of the study the dosage was titrated according to the stool consistency (diarrhoea, loose stool, hard stools or no bowel movement for 2 days, respectively).
Four on-treatment visits were performed on Day 14 (Visit 2), Day 28 (Visit 3), Day 56 (Visit 4) and Day 84 (Visit 5). At each visit bowel movements over the previous period were assessed by the investigator using the patient's daily diary card data.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403897
|Royal Children's Hospital|
|Parkville, Victoria, Australia, 3052|
|Principal Investigator:||Winita Hardikar, MD||Royal Children's Hospital|