An Open Single Centre Study To Assess Treatment of Chronic Constipation in Children

Norgine

Status and phase: Completed; Phase 3

Conditions: Chronic Constipation

Treatments: Drug: Polyethylene glycol 3350 Na bicarbonate NaCl KCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT00403897

99/04

Details and patient eligibility

About

The purpose of this study was to evaluate the safety and efficacy of Movicol in the treatment of chronic constipation in children.

Full description

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.

Enrollment: 81 patients

Sex: All

Ages: 24 months to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children aged 24 months - 11 years old inclusive

• patients with constipation defined as:

  • ≤ 2 spontaneous complete bowel movements per week (over the previous 14 days), and one or more of the following:

    • 1/4 or more of bowel movements with straining
    • 1/4 or more of bowel movements with hard or lumpy stools

• patients in whom these symptoms have been present for ≥ 3 months

• new patients or those whose management is unsatisfactory on current laxative treatment

• patients of either sex

• patients of any ethnic origin

• hospital in-patients or outpatients.

Exclusion criteria

Patients with:

• history of bowel washout within the last 2 months
• intestinal perforation or history of obstruction
• recent history of urinary tract infection (within last month)
• Hirschsprungs disease
• paralytic ileus
• toxic megacolon
• severe inflammatory conditions of the intestinal tract
• clinically uncontrolled renal/hepatic/cardiac disease(s)
• clinically uncontrolled endocrine disorder(s)
• any other severe unstable co-existing disease
• hypersensitivity to macrogol or other constituents of Movicol
• encopresis
• patients who have taken any investigational drug in the last three months
• patients or patients whose parents would in the opinion of the investigator be unable to comply with the requirements of the study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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81 participants in 1 patient group

1

Experimental group

Description:

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;

Treatment:

Drug: Polyethylene glycol 3350 Na bicarbonate NaCl KCl