Movicol in Childhood Constipation (ProMotion Study)
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.
Drug: Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- evaluate the safety and efficacy of Movicol in the treatment of faecal impaction in children.
|Study Start Date:||October 2000|
|Estimated Study Completion Date:||April 2002|
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If on day 8 the patient was still impacted they were withdrawn from study and treated according to their individual needs.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.
|St Richard's Hospital, Royal West Sussex Hospital NHS Trust|
|Chichester, United Kingdom, PO19 4SE|
|Principal Investigator:||David CA Candy, MD||St Richard's Hospital|