Movicol in Childhood Constipation (ProMotion Study)

• Status: Completed
• Trial end date: 2002-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norgine
• Treatments: Lactulose; Polyethylene glycol 3350

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