Movicol in Childhood Constipation (ProMotion Study)

Overview

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.

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 If on day 8 the patient was still impacted they were withdrawn from study and treated according to their individual needs.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

Interventions

Eligibility

Locations (1)

Outcomes