NCT00403858

Movicol in Childhood Constipation (ProMotion Study)

A Single Centre Study to Assess the Safety and Efficacy of Movicol in the Treatment of Faecal Impaction in Children Followed by a Double Blind, Randomised Phase to Compare the Safety and Efficacy of Movicol and Lactulose for Maintenance Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

This was a single centre study comprised of two stages (Parts I and II). Part I was a 9-day open label evaluation of Movicol administered to patients in hospital. This study evaluated the safety and efficacy of Movicol in treating faecal impaction. Movicol was administered over 3 - 7 days to achieve disimpaction.

Detailed description

Patients received Movicol treatment until disimpaction was achieved according to the following regime: Day 1: Ages 2 - 4 received 1 (one) sachet whilst 5 - 11 year olds received 2 (two). Day 2: Ages 2 - 4 received 2 (two) sachets whilst 5 - 11 year olds received 3 (three). Day 3: Ages 2 - 4 received 2 (two) sachets whilst 5 - 11 year olds received 4 (four). Day 4: Ages 2 - 4 received 3 \*three) sachets whilst 5 - 11 year olds received 5 (five). Day 5: Ages 2 - 4 received 3 (three) sachets whilst 5 - 11 year olds received 6 (six). Day 6: Ages 2 - 4 received 4 (four) sachets whilst 5 - 11 year olds received 6 (six). Day 7: Ages 2 - 4 received 4 (four) sachets whilst 5 - 11 year olds received 6 (six). If on day 8 the patient was still impacted they were withdrawn from study and treated according to their individual needs. Disimpaction was assessed clinically (loss of faecal masses and passage of watery stools). Two days following disimpaction patients were randomised (according to the randomisation list) to receive Movicol or Lactulose Dry. During bowel retraining the appropriate maintenance dose of Movicol or Lactulose Dry was determined. Patients were discharged once they were passing regular, painless, bowel actions.

Conditions

• Feces, Impacted

Interventions

Type	Name	Description
DRUG	Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol)
DRUG	Lactulose

Timeline

• Start date: 2000-10-01
• Completion: 2002-04-01
• First posted: 2006-11-27
• Last updated: 2007-01-04

Locations

1 site across 1 country: United Kingdom