A Phase 2 interventional study of Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol) and Lactulose in Feces, Impacted, sponsored by Norgine. Completed at 1 site in United Kingdom. Open to participants aged 2 Years to 11 Years. Per ClinicalTrials.gov, last updated 2007-01-04.
Sponsored by Norgine · Phase 2, Interventional, and Treatment
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If on day 8 the patient was still impacted they were withdrawn from study and treated according to their individual needs.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.
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evaluate the safety and efficacy of Movicol in the treatment of faecal impaction in children.
This study is completed, as verified in Jan 2007. You cannot join it, but the record below documents what was studied.
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Fecal Impaction
Norgine