Feces, Impacted
Conditions
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 If on day 8 the patient was still impacted they were withdrawn from study and treated according to their individual needs.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.
Interventions
DRUGLactulose
Sponsors
Norgine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* patients that, in the opinion of the investigator, are constipated/fecally impacted as to require hospital stay to treat and/or relieve the impaction * children aged 2 - 11 years old inclusive * patients of either sex
Exclusion criteria
Patients with * intestinal perforation or obstruction * severe inflammatory conditions of the intestinal tract * uncontrolled renal/hepatic/cardiac diseases * uncontrolled endocrine disorder(s) * any neuromuscular condition affecting bowel function * hypersensitivity to lactulose or PEG or other constituent of Movicol * patients who have taken any investigational drug in the three months * patients or patients whose parents would in the opinion of the investigator are unable to comply with requirements of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| evaluate the safety and efficacy of Movicol in the treatment of faecal impaction in children. | — |
Countries
United Kingdom
Outcome results
None listed