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

• Status: Completed
• Trial end date: 2003-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norgine
• Treatments: Polyethylene glycol 3350

Criteria

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.