Movicol in Childhood Constipation (ProMotion Study)
|ClinicalTrials.gov Identifier: NCT00403858|
Recruitment Status : Completed
First Posted : November 27, 2006
Last Update Posted : January 4, 2007
|Condition or disease||Intervention/treatment||Phase|
|Feces, Impacted||Drug: Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol) Drug: Lactulose||Phase 2|
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If on day 8 the patient was still impacted they were withdrawn from study and treated according to their individual needs.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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2000|
|Estimated Study Completion Date :||April 2002|
- evaluate the safety and efficacy of Movicol in the treatment of faecal impaction in children.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00403858
|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|