Movicol in Childhood Constipation (ProMotion Study)

Norgine

Status and phase

Completed

Phase 2

Conditions

Feces, Impacted

Treatments

Drug: Lactulose

Drug: Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00403858

99/05 (Part I)

Details and patient eligibility

About

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.

Full 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If on day 8 the patient was still impacted they were withdrawn from study and treated according to their individual needs.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.

Sex

All

Ages

2 to 11 years old

Volunteers

No Healthy Volunteers

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