Movicol in Childhood Constipation (ProMotion Study)

Condition(s) targeted: Feces, Impacted

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

Phase: Phase 2

Status: Completed

Sponsored by: Norgine

Official(s) and/or principal investigator(s):
David CA Candy, MD, Principal Investigator, Affiliation: St Richard's Hospital

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.

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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: evaluate the safety and efficacy of Movicol in the treatment of faecal impaction in children.

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If on day 8 the patient was still impacted they were withdrawn from study and treated according to their individual needs.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

Minimum age: 2 Years. Maximum age: 11 Years. Gender(s): Both.

Criteria:

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

St Richard's Hospital, Royal West Sussex Hospital NHS Trust, Chichester PO19 4SE, United Kingdom

Related publications:

Dalziel SR et al. Efficacy of Movicol in children with faecal impaction. A series of en case histories (A13). British Society of Paediatric Gastroenterologists Annual Meeting. Bristol:21-22, Jan 2000

Attar A, Lemann M, Ferguson A, Halphen M, Boutron MC, Flourie B, Alix E, Salmeron M, Guillemot F, Chaussade S, Menard AM, Moreau J, Naudin G, Barthet M. Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. Gut. 1999 Feb;44(2):226-30.

Starting date: October 2000
Ending date: April 2002
Last updated: January 3, 2007