NCT00403897

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

An Open Single Centre Study To Assess the Safety and Efficacy of Movicol in the Treatment of Chronic Constipation in Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 24 Months – 11 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Chronic Constipation

Interventions

Type	Name	Description
DRUG	Polyethylene glycol 3350 Na bicarbonate NaCl KCl	6.9g sachet, oral

Timeline

• Start date: 2001-08-01
• Completion: 2003-01-01
• First posted: 2006-11-27
• Last updated: 2008-04-16

Locations

1 site across 1 country: Australia