Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT00403858
Brief 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If on day 8 the patient was still impacted they were withdrawn from study and treated according to their individual needs.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.
Study:
NCT00403858
Study Brief:
Protocol Section:
NCT00403858